A President Betrayed by Bureaucrats: Scott Atlas’s Masterpiece on the COVID Disaster
By: Jeffrey A. Tucker
The Epoch Times
December 5, 2021
I’m a voracious reader of Covid books but nothing could have prepared me for Scott Atlas’s A Plague Upon Our House, a full and mind-blowing account of the famed scientist’s personal experience with the Covid era and a luridly detailed account of his time at the White House. The book is hot fire, from page one to the last, and will permanently affect your view of not only this pandemic and the policy response but also the workings of public health in general.
Atlas’s book has exposed a scandal for the ages. It is enormously valuable because it fully blows up what seems to be an emerging fake story involving a supposedly Covid-denying president who did nothing vs. heroic scientists in the White House who urged compulsory mitigating measures consistent with prevailing scientific opinion. Not one word of that is true. Atlas’s book, I hope, makes it impossible to tell such tall tales without embarrassment.
Anyone who tells you this fictional story (including Deborah Birx) deserves to have this highly credible treatise tossed in his direction. The book is about the war between real science (and genuine public health), with Atlas as the voice for reason both before and during his time in the White House, vs. the enactment of brutal policies that never stood any chance of controlling the virus while causing tremendous damage to the people, to human liberty, to children in particular, but also to billions of people around the world.
For the reader, the author is our proxy, a reasonable and blunt man trapped in a world of lies, duplicity, backstabbing, opportunism, and fake science. He did his best but could not prevail against a powerful machine that cares nothing for facts, much less outcomes.
If you have heretofore believed that science drives pandemic public policy, this book will shock you. Atlas’s recounting of the unbearably poor thinking on the part of government-based “infectious disease experts” will make your jaw drop (thinking, for example, of Birx’s off-the-cuff theorizing about the relationship between masking and controlling case spreads).
Throughout the book, Atlas points to the enormous cost of the machinery of lockdowns, the preferred method of Anthony Fauci and Deborah Birx: missed cancer screenings, missed surgeries, nearly two years of educational losses, bankrupted small business, depression and drug overdoses, overall citizen demoralization, violations of religious freedom, all while public health massively neglected the actual at-risk population in long-term care facilities. Essentially, they were willing to dismantle everything we called civilization in the name of bludgeoning one pathogen without regard to the consequences.
The fake science of population-wide “models” drove policy instead of following the known information about risk profiles. “The one unusual feature of this virus was the fact that children had an extraordinarily low risk,” writes Atlas. “Yet this positive and reassuring news was never emphasized. Instead, with total disregard of the evidence of selective risk consistent with other respiratory viruses, public health officials recommended draconian isolation of everyone.”
“Restrictions on liberty were also destructive by inflaming class distinctions with their differential impact,” he writes, “exposing essential workers, sacrificing low-income families and kids, destroying single-parent homes, and eviscerating small businesses, while at the same time large companies were bailed out, elites worked from home with barely an interruption, and the ultra-rich got richer, leveraging their bully pulpit to demonize and cancel those who challenged their preferred policy options.”
During continued chaos, in August 2020, Atlas was called by Trump to help, not as a political appointee, not as a PR man for Trump, not as a DC fixer but as the only person who in nearly a year of an unfolding catastrophe had a health-policy focus. He made it clear from the outset that he would only say what he believed to be true; Trump agreed that this was precisely what he wanted and needed. Trump got an earful and gradually came around to a more rational view than that which caused him to wreck the American economy and society with his own hands and against his instincts.
In Task Force meetings, Atlas was the only person who showed up with studies and on-the-ground information as opposed to mere charts of infections easily downloadable from popular websites. “A bigger surprise was that Fauci did not present scientific research on the pandemic to the group that I witnessed. Likewise, I never heard him speak about his critical analysis of any published research studies. This was stunning to me. Aside from intermittent status updates about clinical trial enrollments, Fauci served the Task Force by offering an occasional comment or update on vaccine trial participant totals, mostly when the VP would turn to him and ask.”
When Atlas spoke up, it was almost always to contradict Fauci/Birx but he received no backing during meetings, only to have many people in attendance later congratulate him for speaking out. Still, he did, by private meetings, have a convert in Trump himself, but by then it was too late: not even Trump could prevail against the wicked machine he had permissioned into operation.
It’s a Mr. Smith Goes to Washington story but applied to matters of public health. From the outset of this disease panic, policy came to be dictated by two government bureaucrats (Fauci and Birx) who, for some reason, were confident in their control over media, bureaucracies, and White House messaging, despite every attempt by the president, Atlas, and a few others to get them to pay attention to the actual science about which Fauci/Birx knew and care little.
When Atlas would raise doubts about Birx, Jared Kushner would repeatedly assure him that “she is 100% MAGA.” Yet we know for certain that this is not true. We know from a different book on the subject that she only took the position with the anticipation that Trump would lose the presidency in the November election. That’s hardly a surprise; it’s the bias expected from a career bureaucrat working for a deep-state institution.
Fortunately, we now have this book to set the record straight. It gives every reader an inside look at the workings of a system that wrecked our lives. If the book finally declines to explain the hell that was visited upon us—every day we still ask the question why?—it does provide an accounting of the who, when, where, and what. Tragically, too many scientists, media figures, and intellectuals, in general, went along. Atlas’s account shows exactly what they signed up to defend, and it’s not pretty.
The cliche that kept coming to mind as I read is “breath of fresh air.” That metaphor describes the book perfectly: blessed relief from relentless propaganda. Imagine yourself trapped in an elevator with stultifying air in a building that is on fire and the smoke gradually seeps in from above. Someone is in there with you and he keeps assuring you that everything is fine, when it is obviously not.
That’s a pretty good description of how I felt from March 12, 2020, and onward. That was the day that President Trump spoke to the nation and announced that there would be no more travel from Europe. The tone in his voice was spooky. It was obvious that more was coming. He had fallen sway to extremely bad advice, perhaps he was willing to push lockdowns as a plan to deal with a respiratory virus that was already widespread in the US from perhaps 5 to 6 months earlier.
It was the day that the darkness descended. A day later (March 13), the HHS distributed its lockdown plans for the nation. That weekend, Trump met for many hours with Anthony Fauci, Deborah Birx, son-in-law Jared Kushner, and only a few others. He came around to the idea of shutting down the American economy for two weeks. He presided over the calamitous March 16, 2020, press conference, at which Trump promised to beat the virus through general lockdowns.
Of course, he had no power to do that directly but he could urge it to happen, all under the completely delusional promise that doing so would solve the virus problem. Two weeks later, the same gang persuaded him to extend the lockdowns.
Trump went along with the advice because it was the only advice he was fed at the time. They made it appear that the only choice that Trump had—if he wanted to beat the virus—was to wage war on his policies that were pushing for a stronger, healthier economy. After surviving two impeachment attempts, and beating back years of hate from a nearly united media afflicted by severe derangement syndrome, Trump was finally hornswoggled.
Atlas writes: “On this highly important criterion of presidential management—taking responsibility to fully take charge of policy coming from the White House—I believe the president made a massive error in judgment. Against his gut feeling, he delegated authority to medical bureaucrats, and then he failed to correct that mistake.”
The truly tragic fact that both Republicans and Democrats do not want spoken about is that this whole calamity is that did indeed begin with Trump’s decision. On this point, Atlas writes:
“Yes, the president initially had gone along with the lockdowns proposed by Fauci and Birx, the “fifteen days to slow the spread,” even though he had serious misgivings. But I still believe the reason that he kept repeating his one question—“Do you agree with the initial shutdown?”—whenever he asked questions about the pandemic was precisely because he still had misgivings about it.”
Large parts of the narrative are devoted to explaining precisely how and to what extent Trump had been betrayed. “They had convinced him to do exactly the opposite of what he would naturally do in any other circumstance,” Atlas writes, that is
“to disregard his common sense and allow grossly incorrect policy advice to prevail…. This president, widely known for his signature “You’re fired!” declaration, was misled by his closest political intimates. All for fear of what was inevitable anyway—skewering from an already hostile media. And on top of that tragic misjudgment, the election was lost anyway. So much for political strategists.”
There are so many valuable parts to the story that I cannot possibly recount them all. The language is brilliant, e.g. he calls the media “the most despicable group of unprincipled liars one could ever imagine.” He proves that assertion in page after page of shocking lies and distortions, mostly driven by political goals.
I was particularly struck by his chapter on testing, mainly because that whole racket mystified me throughout. From the outset, the CDC bungled the testing part of the pandemic story, attempting to keep the tests and process centralized in DC at the very time when the entire nation was in panic. Once that was finally fixed, months too late, mass and indiscriminate PCR testing became the desiderata of success within the White House. The problem was not just with the testing method:
“Fragments of dead virus hang around and can generate a positive test for many weeks or months, even though one is not generally contagious after two weeks. Moreover, PCR is extremely sensitive. It detects minute quantities of the virus that do not transmit infection…. Even the New York Times wrote in August that 90 percent or more of positive PCR tests falsely implied that someone was contagious. Sadly, during my entire time at the White House, this crucial fact would never even be addressed by anyone other than me at the Task Force meetings, let alone because for any public recommendation, even after I distributed data proving this critical point.”
The other problem is the wide assumption that more testing (however inaccurate) of whomever, whenever was always better. This model of maximizing tests seemed like a leftover from the HIV/AIDS crisis in which tracing was mostly useless in practice but at least made some sense in theory. For a widespread and mostly wild respiratory disease transmitted the way a cold virus is transmitted, this method was hopeless from the beginning. It became nothing but make work for tracing bureaucrats and testing enterprises that in the end only provided a fake metric of “success” that served to spread public panic.
Early on, Fauci had clearly said that there was no reason to get tested if you had no symptoms. Later, that common-sense outlook was thrown out the window and replaced with an agenda to test as many people as possible regardless of risk and regardless of symptoms. The resulting data enabled Fauci/Birx to keep everyone in a constant state of alarm. More test positivity to them implied only one thing: more lockdowns. Businesses needed to close harder, we all needed to mask harder, schools needed to stay closed longer, and travel needed to be even more restricted. That assumption became so entrenched that not even the president’s wishes (which had changed from Spring to Summer) made any difference.
Atlas’s first job, then, was to challenge this whole indiscriminate testing agenda. To his mind, testing needed to be about more than accumulating endless amounts of data, much of it without meaning; instead, testing should be directed toward a public-health goal. The people who needed tests were the vulnerable populations, particularly those in nursing homes, to save lives among those who were threatened with severe outcomes. This push to test, contact trace, and quarantine anyone and everyone regardless of known risk was a huge distraction, and also caused huge disruption in schooling and enterprise.
To fix it meant changing the CDC guidelines. Atlas’s story of attempting to do that is eye-opening. He wrestled with every manner of bureaucrat and managed to get new guidelines written, only to find that they had been mysteriously reverted to the old guidelines one week later. He caught the “error” and insisted that his version prevail. Once they were issued by the CDC, the national press was all over it, with the story that the White House was pressuring the scientists at the CDC in terrible ways. After a week-long media storm, the guidelines changed yet again. All of Atlas’s work was made null.
Talk about discouraging! It was also Atlas’s first full experience in dealing with deep-state machinations. It was this way throughout the lockdown period, machinery in place to implement, encourage, and enforce endless restrictions but no one person, in particular, was there to take responsibility for the policies or the outcomes, even as the ostensible head of state (Trump) was on record both publicly and privately opposing the policies that no one could seem to stop.
As an example of this, Atlas tells the story of bringing some massively important scientists to the White House to speak with Trump: Martin Kulldorff, Jay Bhattacharya, Joseph Ladapo, and Cody Meissner. People around the president thought the idea was great. But somehow the meeting kept being delayed. Again and again. When it finally went ahead, the schedulers only allowed for 5 minutes. But once they met with Trump himself, the president had other ideas and prolonged the meeting for an hour and a half, asking the scientists all kinds of questions about viruses, policy, the initial lockdowns, the risks to individuals, and so on.
The president was so impressed with their views and knowledge—what a dramatic change that must have been for him—that he invited filming to be done plus pictures to be taken. He wanted to make it a big public splash. It never happened. Literally. White House press somehow got the message that this meeting never happened. The first anyone would have known about it other than White House employees is from Atlas’s book.
Two months later, Atlas was instrumental in bringing in not only two of those scientists but also the famed Sunetra Gupta of Oxford. They met with the HHS secretary but this meeting too was buried in the press. No dissent was allowed. The bureaucrats were in charge, regardless of the wishes of the president.
Another case in point was during Trump’s bout with Covid in early October. Atlas was nearly sure that he would be fine but he was forbidden from talking to the press. The entire White House communications office was frozen for four days, with no one speaking to the press. This was against Trump’s wishes. This left the media to speculate that he was on his deathbed, so when he came back to the White House and announced that Covid is not to be feared, it was a shock to the nation. From my point of view, this was truly Trump’s finest moment. To learn of the internal machinations happening behind the scenes is pretty shocking.
I can’t possibly cover the wealth of material in this book, and I expect this brief review to be one of several that I write. I do have a few disagreements. First, I think the author is too uncritical toward Operation Warp Speed and doesn’t address how the vaccines were wildly oversold, to say nothing of growing concerns about safety, which were not addressed in the trials. Second, he seems to approve of Trump’s March 12th travel restrictions, which struck me as brutal and pointless, and the real beginning of the unfolding disaster. Third, Atlas inadvertently seems to perpetuate the distortion that Trump recommended ingesting bleach during a press conference. I know that this was all over the papers. But I’ve read the transcript of that press conference several times and find nothing like this. Trump makes clear that he was speaking about cleaning surfaces. This might be yet another case of outright media lies.
All that aside, this book reveals everything about the insanity of 2020 and 2021, years in which good sense, good science, historical precedent, human rights, and concerns for human liberty were all thrown into the trash, not just in the US but all over the world.
Atlas summarizes the big picture:
“in considering all the surprising events that unfolded in this past year, two, in particular, stand out. I have been shocked at the enormous power of government officials to unilaterally decree a sudden and severe shutdown of society—to simply close businesses and schools by edict, restrict personal movements, mandate behavior, regulate interactions with our family members, and eliminate our most basic freedoms, without any defined end and with little accountability.”
Atlas is correct that “the management of this pandemic has left a stain on many of America’s once noble institutions, including our elite universities, research institutes and journals, and public health agencies. Earning it back will not be easy.”
Internationally, we have Sweden as an example of a country that (mostly) kept its sanity. Domestically, we have South Dakota as an example of a place that stayed open, preserving freedom throughout. And thanks in large part to Atlas’s behind-the-scenes work, we have the example of Florida, whose governor did care about the actual science and ended up preserving freedom in the state even as the elderly population there experienced the greatest possible protection from the virus.
We all owe Atlas an enormous debt of gratitude, for it was he who persuaded the Florida governor to choose the path of focussed protection as advocated by the Great Barrington Declaration, which Atlas cites as the “single document that will go down as one of the most important publications in the pandemic, as it lent undeniable credibility to focused protection and provided courage to thousands of additional medical scientists and public health leaders to come forward.”
Atlas experienced the slings, arrows, and worse. The media and the bureaucrats tried to shut him up, shut him down, and body bag him professionally and personally. Canceled,meaning removed from the roster of functional, dignified human beings. Even colleagues at Stanford University joined in the lynch mob, much to their disgrace. And yet this book is that of a man who has prevailed against them.
In that sense, this book is easily the most crucial first-person account we have so far. It is gripping, revealing, devastating for the lockdowners and their vaccine-mandating successors, and a true classic that will stand the test of time. It’s simply not possible to write the history of this disaster without a close examination of this erudite first-hand account.
Jeffrey Tucker is founder and president of the Brownstone Institute. He is the author of five books, including “Right-Wing Collectivism: The Other Threat to Liberty.”
Posted inUncategorized|Comments Off on Scott Atlas experienced the slings, arrows, and worse. The media and the bureaucrats tried to shut him up, shut him down, and body bag him professionally and personally. Canceled, meaning removed from the roster of functional, dignified human beings. Even colleagues at Stanford University joined in the lynch mob, much to their disgrace. And yet this book on the COVID disaster is that of a man who has prevailed against them.
A vacuum was created 30 years ago by the peaceful collapse of both the Imperial Russian state constructed over centuries from Peter the Great to Stalin and the Bolshevik dictatorship of the Soviet Union that was purporting to perfect Marxism and spread it to a yearning and grateful world. That vacuum has been filled by China, assisted at least tentatively by selected opportunistic allies.
So thorough, sudden, and bloodless was the American-led triumph over the Soviet Union that it has required 30 years for a serious replacement challenge to the West to emerge. At the end of World War I, when Germany effectively surrendered but was not occupied, the supreme Allied commander, France’s Marshal Foch, correctly described the 1919 Treaty of Versailles as “a 20-year armistice.”
In contrast, the rivalry between the two most powerful victorious nations in World War II, the United States and the Soviet Union began within just a couple of years of the end of the war. When Stalin violated all of his promises in the Yalta Conference agreement to vacate the countries the Red Army had “liberated” from Nazi Germany, he also violated the spheres of influence agreement with British Prime Minister Churchill in Moscow in October 1944, concerning Greece and Yugoslavia. The ensuing confrontation continued for nearly 45 years.
The tactics of re-occupying the vacuum have been for the supposedly communist People’s Republic of China to maintain a communist dictatorship but shift to a primarily capitalist economy, the exact opposite of Mikhail Gorbachev’s reform of the Soviet Union: retention of a command economy while democratizing the political process, a fairly predictable recipe for the complete breakdown of the Soviet state.
While China has been executing what is probably history’s most remarkable story of national economic development, and the first return to Great Power status of a country that had long lost that status, the ragged shards, and fragments of defeated international communism have quickly rediscovered their supposed true vocation as conservators of the environment and therefore the future of the planet.
They have assisted vitally in the confection of an anti-capitalist dogma based on retardation of economic activity, and almost unbelievably, have sold it as a Green inspiration to the Western elites. The luxury of having no rival in the world and only the comparative irritant of almost stateless terrorist organizations, which inflict tragic outrages but cannot threaten the existence of great nations, induced the United States into the first bout of self-hate in its history.
Centuries of often excessive but certainly not unfounded self-commendation as a free and virtuous meritocracy, a champion of freedom in the world, that has made the greatest effort of any in history to raise a subjugated racial minority to a status of equality, have degenerated into an acutely self-critical disorder and caused the United States to detach from its legitimate global strategic interests.
This providential facilitation of Chinese aggrandizement has come in stages. The Clinton, Obama, and both Bush Administrations assumed that concessions and preferments to China would result in that country becoming a progressively more cooperative member of the international community. They all also underestimated the capacity of Russia, sundered though it is, to create problems by conniving with China, Iran, and Turkey in particular, to aggravate and destabilize American interests and alliances.
In this process, most of the Western alliance has become soft and useless, a military parasite of the United States that has failed to maintain its comprehensive military superiority over China. Germany is almost a neutral state and an energy vassal of Russia.
The West should start by recognizing the skill of its principal rivals. The Chinese leadership picked the financial and intellectual and scientific pockets of the West for decades, manipulated the Chinese currency, and dumped their manufactures on the world, exporting unemployment to the West while seducing it.
Their supreme triumph was translating their incompetence in releasing a dangerous virus, communicating it to the world, and shuttering down the economy of the Western world for more than a year. It was dishonest and uncivilized but it was a masterstroke, and as the news every day tells us, our governments are still floundering and flailing as a result.
It enabled the defeat of President Trump, who was resurrecting a satisfactory strategic balance in the world, a cause that history will judge should have motivated his countrymen to be more tolerant of his stylistic infelicities.
For good measure, the last few U.S. secretaries of defense, despite the enormous investment that the Trump Administration made in upgrading America’s military capacity, failed to see the possibilities for hypersonic missiles and failed to assure adequate defense for the Nimitz class aircraft carriers which project American power but are currently vulnerable to sophisticated weapons in the hands of America’s rivals.
The press, academia, the oligarchic social media cartel, Hollywood, Wall Street, Silicon Valley, and major league sports, have all generally failed shamefully to maintain national self-esteem and even to permit elemental vigilance about the dangerous deterioration of America’s position in the world.
Fortunately, the people are wiser; they were snowed, if not swindled, by the massive coalition of Mr. Trump’s enemies last year, who had 95 percent of the press and outspent Trump two to one. Conditions are eroding so swiftly, the country is seeing that this woke idiocy isn’t affordable, and they are almost certain to opt for national renascence and peace through strength next time.
China and Russia have been so successful in the last 18 months that they may be overconfident. If China attacks Taiwan, any substantial deployment of U.S. airpower to that island, cooperating with the Taiwanese, would destroy an attempted amphibious attack of the 500,000 soldiers that would be needed, as they attempted to cross the Formosa Strait, which is four times as wide as the English Channel at Normandy.
The United States would have to send the message that it would not escalate hostilities or extend them beyond the defense of Taiwan; it would be tense, but if the People’s Republic is insolent enough to attempt such a thing it could certainly be defeated.
Ukraine is more complicated. It has not been a successful independent country, though post-Soviet Russia is no marvel of good government, either. It is not improbable that many ethnic Russians in eastern Ukraine would rather be Russians than Ukrainians and we cannot go to war to prevent that any more than the British and French could go to war to prevent Sudetenland from joining Germany in 1938.
To the extent that Russia attempted to subdue non-Russian Ukraine, though, the West could frustrate that by heavily supplying the Ukrainian armed forces. Russia remains a sophisticated armaments maker but it does not have the economic or political strength (its GDP is smaller than Canada’s) to subdue a seriously motivated and well-armed Ukraine that, without its Russian fifth-column, would still have a population of more than 30 million.
The strategic equation is complicated and increasingly dangerous because this administration is so feeble and the United States military has been so incompetently directed recently. Yet the United States is fundamentally a much stronger country than China or Russia, and if it inspires and leads its allies, it is at the head of an overwhelmingly powerful coalition of free states.
We have three more years to muddle through before the leadership that is all that is lacking, can be installed. It is perilous but far from hopeless.
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“I am Mother. I have traveled many miles to this place. Who am I, and why have I come all this way? I am Mother, and I have come all this way because it is near the time of His birth. But what is my origin and how have I been prepared for this event?
I was born of godly parents, St. Anne and St Joachim. I was born full of grace – and in grace I remained, For one day I would carry One who was holy and unblemished, Indeed one day I would carry the Son of God, And therefore a pure vessel was required.
I was not made pure by the removal of sin, I was born pure by the exclusion of sin, Therefore I was born as a stranger into a sinful world, Seeing all the consequences of sin without partaking of it. This was done because of the One I would carry. Was He also a stranger in the world? No, because it was His world into which He was born, But they considered Him a stranger, And therefore the world crucified the very One who had come to save it.
As the Mother of the Redeemer, I was myself redeemed, But I was redeemed before original sin could touch me, And not after it was already a part of who I was. I was born of original grace, not original sin, And in grace I walked, And in grace I carried Him who in justice gives all gifts as He wills.
Who am I? I am Mother. And I have walked many miles. I was born mortal but full of grace, For would the Holy Spirit, the bearer of grace, Consent to be the spouse of one who was not conceived in grace herself? Therefore when I was proclaimed full of grace, It was not at that moment it was granted, But rather from my conception it had been so, For could the giver of grace Dwell in one who had not been immersed in grace from her own beginning? Therefore from the time I knew life, I knew grace.
I am Mother. I have traveled many miles Because it is near the time of His birth. I was conceived immaculate because of the One I was called to bear. God’s grace is outside of time, And comes forth from One who knows all things; Therefore, my future “yes” provided the fertile ground For the grace that was at the beginning imbued in me. For what is to come God sees, And therefore acts with perfect justice in that circumstance which is unknown to man. Therefore the grace I was given at conception Was given in anticipation of the grace that Christ would bring Into the world, And yet was fully given in me before it was granted to the world. For time holds no power over God who indeed has set all in motion. This fullness of grace came about because of my Immaculate Conception, And therefore if you ask who I am, That is who I am, I am the Immaculate Conception.
Who am I and why have I come all this way? I am the Mother of God, And I have come all this way because it is near the time of His birth. I carry Him in my womb, the One who is the giver of all grace, And this bed that has been prepared for Him Is bathed in grace as befits the Son of God. Ask not how this can be For God has redeemed me as He redeems the world, But He has redeemed me before His advent, Indeed from my beginning. Because to be the Mother of the giver of grace, And to provide a bed made holy in anticipation of the One who would there rest, This is what was required, And therefore was given.
Who am I? I am Mother. And I have traveled far. For He comes.“
-S
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Flashback because a NewsMax source said “Francis is Dying”: It might be Good for all of us & for Francis to Read about the “Gruesome Death of Arius” found in the Ecclesiastical History
Today’s NewsMax said:
Newsmax@newsmaxBREAKING: A Vatican source tells Newsmax’s John Gizzi that “Pope Francis is dying,” with insiders saying they believe the Pontiff will not survive past 2022. https://bit.ly/3rHKgGo[https://twitter.com/newsmax/status/1468237821458718726] Here is a appropriate flashback post form if this is true:
I have read the letters of your piety, in which you have requested me to make known to you the events of my times relating to myself, and to give an account of that most impious heresy of the Arians, in consequence of which I have endured these sufferings, and also of the manner of the death of Arius. With two out of your three demands I have readily undertaken to comply, and have sent to your Godliness what I wrote to the Monks; from which you will be able to learn my own history as well as that of the heresy. But with respect to the other matter, I mean the death, I debated with myself for a long time, fearing lest any one should suppose that I was exulting in the death of that man. But yet, since a disputation which has taken place among you concerning the heresy, has issued in this question, whether Arius died after previously communicating with the Church; I therefore was necessarily desirous of giving an account of his death, as thinking that the question would thus be set at rest, considering also that by making this known I should at the same time silence those who are fond of contention. For I conceive that when the wonderful circumstances connected with his death become known, even those who before questioned it will no longer venture to doubt that the Arianheresy is hateful in the sight of God. – Saint Athanasius’s letter to Serapionon the death of Arius
Today, Mary Ann Kreitzer, the President of the Les Femmes-The Truth website, asked for prayers for Francis saying:
As a seventy-something old lady, I relate to that metaphor since the pendulum on my own clock is moving faster these days…
… How many more years (or days) does he have left on his timeline before he succumbs to the grim reaper and faces his Creator? What will he say about his service to Holy Mother Church?
I cringed recently when I read about the pope’s high praise for Fr. James Martin, S.J. whose scandals cry out to heaven. Fr. Martin has over 300,000 followers on his Twitter account. How many is he dragging to the precipice with his enthusiastic advocacy for sins that cry to heaven for vengeance?
It might be good for all of us and for Francis to read about the “Gruesome Death of Arius” found in the Ecclesiastical History:
After the Synod of Jerusalem, Arius went to Egypt, but as he could not obtain permission to hold communion with the Church of Alexandria, he returned to Constantinople. As all those who had embraced his sentiments, and those who were attached to Eusebius, bishop of Nicomedia, had assembled cunningly in that city for the purpose of holding a council, Alexander, who was then ordering the see of Constantinople, used every effort to dissolve the council. But as his endeavors were frustrated, he openly refused all covenant with Arius, affirming that it was neither just nor according to ecclesiastical canons, to make powerless their own vote, and that of those bishops who had been assembled at Nicæa, from nearly every region under the sun. When the partisans of Eusebius perceived that their arguments produced no effect on Alexander, they had recourse to contumely, and threatened that unless he would receive Arius into communion on a stated day, he should be expelled from the church, and that another should be elected in his place who would be willing to hold communion with Arius.
They then separated, the partisans of Eusebius to await the time they had fixed for carrying their menaces into execution, and Alexander to pray that the words of Eusebius might be prevented from being carried into deed. His chief source of fear arose from the fact that the emperor had been persuaded to give way. On the day before the appointed day he prostrated himself before the altar, and continued all the night in prayer to God, that his enemies might be prevented from carrying their schemes into execution against him.
Late in the afternoon, Arius, being seized suddenly with pain in the stomach, was compelled to repair to the public place set apart for emergencies of this nature. As some time passed away without his coming out, some persons, who were waiting for him outside, entered, and found him dead and still sitting upon the seat. When his death became known, all people did not view the occurrence under the same aspect. Some believed that he died at that very hour, seized by a sudden disease of the heart, or suffering weakness from his joy over the fact that his matters were falling out according to his mind; others imagined that this mode of death was inflicted on him in judgment, on account of his impiety. Those who held his sentiments were of opinion that his death was brought about by magical arts.
It will not be out of place to quote what Athanasius, bishop of Alexandria, stated on the subject. The following is his narrative:
“Arius, the author of the heresy and the associate of Eusebius, having been summoned before the most blessed Constantine Augustus, at the solicitation of the partisans of Eusebius, was desired to give in writing an exposition of his faith. He drew up this document with great artfulness, and, like the devil, concealed his impious assertions beneath the simple words of Scripture. The most blessed Constantine said to him, ‘If you hold any other doctrines than those which are here set forth, render testimony to the truth. but if you perjure yourself, the Lord will punish you,’ and the wretched man swore that he held no sentiments except those specified in the document.
Soon after he went out, and judgment was visited upon him, for he bent forwards and burst in the middle. With all men life terminates in death. We must not blame a man, even if he be an enemy, merely because he died, for it is uncertain whether we shall live till the evening. But the end of Arius was so singular that it seems worthy of some remark. The partisans of Eusebius threatened to reinstate him in the church, and Alexander, bishop of Constantinople, opposed their intention. Arius placed his confidence in the power and menaces of Eusebius. It was Saturday, and he expected the next day to be re-admitted into the church. The dispute ran high. The partisans of Eusebius were loud in their menaces, while Alexander had recourse to prayer. The Lord was the judge, and declared himself against the unjust. A little before sunset Arius was compelled by a want of nature to enter the place appointed for such emergencies, and here he lost at once both restoration to communion and his life. The most blessed Constantine was amazed when he heard of this occurrence, and regarded it as the punishment of perjury. It then became evident to every one that the menaces of Eusebius were absolutely futile, and that the expectations of Arius were vain and foolish. It also became manifest that the Arian heresy had met with condemnation from the Savior as well as from the pristine church. Is it not then astonishing that some are still found who seek to exculpate him whom the Lord has condemned, and to defend a heresy of which the author was not permitted by our Lord to be rejoined to the church? We have been duly informed that this was the mode of the death of Arius. It is said that for a long period subsequently no one would make use of the seat on which he died. Those who were compelled by necessities of nature to visit the public place, always avoided with horror the precise spot on which the impiety of Arius had been visited with judgment. At a later epoch a certain rich and powerful man, who had embraced the Arian tenets, bought the place of the public, and built a house on the spot, in order that the occurrence might fall into oblivion, and that there might be no perpetual memorial of the death of Arius.” [http://gloriaromanorum.blogspot.com/2017/01/the-death-of-arius.html?m=1] Pray an Our Father now for reparation for the sins committed because of Francis’s Amoris Laetitia.
Pray an Our Father now for the restoration of the Church as well as the Triumph of the Kingdom of the Sacred Heart and the Immaculate Heart of Mary.
Stop for a moment of silence, ask Jesus Christ what He wants you to do now and next. In this silence remember God, Father, Son and Holy Ghost – Three Divine Persons yet One God, has an ordered universe where you can know truth and falsehood as well as never forget that He wants you to have eternal happiness with Him as his son or daughter by grace. Make this a practice. By doing this you are doing more good than reading anything here or anywhere else on the Internet.
Francis Notes:
– Doctor of the Church St. Francis de Sales totally confirmed beyond any doubt the possibility of a heretical pope and what must be done by the Church in such a situation:
“[T]he Pope… WHEN he is EXPLICITLY a heretic, he falls ipso facto from his dignity and out of the Church, and the Church MUST either deprive him, or, as some say, declare him deprived, of his Apostolic See.” (The Catholic Controversy, by St. Francis de Sales, Pages 305-306)
– If Francis betrays Benedict XVI & the”Roman Rite Communities” like he betrayed the Chinese Catholics we must respond like St. Athanasius, the Saintly English Bishop Robert Grosseteste & “Eminent Canonists and Theologians” by “Resist[ing]” him: https://www.thecatholicmonitor.com/2021/12/if-francis-betrays-benedict-xvi.html
– LifeSiteNews, “Confusion explodes as Pope Francis throws magisterial weight behind communion for adulterers,” December 4, 2017:
The AAS guidelines explicitly allows “sexually active adulterous couples facing ‘complex circumstances’ to ‘access the sacraments of Reconciliation and the Eucharist.'”
– On February 2018, in Rorate Caeli, Catholic theologian Dr. John Lamont:
“The AAS statement… establishes that Pope Francis in Amoris Laetitia has affirmed propositions that are heretical in the strict sense.”
– On December 2, 2017, Bishop Rene Gracida:
“Francis’ heterodoxy is now official. He has published his letter to the Argentina bishops in Acta Apostlica Series making those letters magisterial documents.”
Pray an Our Father now for the restoration of the Church by the bishops by the grace of God.
Letter #166, 2021, Tue, Dec 7: No MassInboxDr. Robert Moynihanvia icontactmail4.com 5:49 PM (38 minutes ago)to me “If German bishops and priests were applying and defending the principles of the Catholic faith, they would certainly find themselves in opposition to the views presented in mainstream media and politics, but this would make the Church so much more attractive to so many people, who are desperately looking for a good shepherd right now.” —A young German Catholic man named Moritz Scholtysik who is protesting the exclusion of the unvaccinated from Mass in Berlin, Germany, beginning at the end of November. He is interviewed below Letter #166, 2021, Tuesday, December 7: In Berlin, the unvaccinated are barred from attending Mass… The news from Berlin is profoundly troubling. What is of greatest concern is the possible creation of two classes of Catholics, in this case, one “vaccinated” and one “unvaccinated.” This would be unprecedented, and a terrible tragedy, and, therefore, some superior authority ought to advise the archbishop of Berlin, Heiner Koch, 67, who has taken this decision, that this measure is not in harmony with the perennial Catholic faith, as it marginalizes an entire group of Catholics, rather than embracing and nourishing them. *** An important interview conducted with a number of German Catholics in Berlin by Maike Hickson of Lifesitenews (herself born in Germany)published yesterday here — and today picked up by the redoubtable Bishop Henry Gracida, 98 (born in 1923, he will turn 99 next year, he was bishop of Corpus Christi, Texas, from 1983-1997, and has a conservative Catholic blog here) — reveals a worrisome situation is developing, which could, potentially, spread widely: Berlin Catholics without proof of “vaccination” against the Covid virus, or a notice of recovery from the virus, are being — since the end of November — prevented from attending Mass and receiving the sacraments in the diocese of Berlin, the capital of Germany. This seems not to take into scientific facts reported even by the mainstream media: 1) there are many people with various auto-immune problems who, together with their doctors, have decided it is quite unwise and imprudent for them to receive any vaccination, especially untested ones; (See this May 18 report in TheWashington Post: “Vaccine makers excluded immunocompromised people from their clinical trials in an understandable rush to develop a way to protect as many people as quickly as possible. As a result, there’s limited information about how this group is reacting to the shots…”) 2) the evidence for the efficacy of these incompletely tested “vaccines” is still ambiguous; cases are now being reported of limited protection among “among older people and those with weakened immune systems” and evidence is emerging that “their protection against infection [that is, the effectiveness of the vaccines to prevent infection]… has fallen.” (See this November 11 report in the New York Times: “As tens of millions who are eligible in the United States consider signing up for a Covid-19 booster shot, a growing body of early global research shows that the vaccines authorized in the United States remain highly protective against the disease’s worst outcomes over time, with some exceptions among older people and those with weakened immune systems. But while the vaccines’ effectiveness against severe disease and hospitalization has mostly held steady, even through the summer surge of the highly transmissible Delta variant, a number of published studies show that their protection against infection, with or without symptoms, has fallen.” [Editor’s note: emphasis added] *** ”A desire for presence” The Church has always believed that, even in time of plague, or when confronting diseases like leprosy, the sacraments of the Church must be made available, if at all possible, to the sick. See this November 22 article in Church Life Journal by Timothy O’Malley entitled “Saints of the Black Death”: ”In 1374, St. Catherine experienced the plague in Siena, where she lost three siblings and other relatives. Everyone left the town as the best medical advice said. St. Catherine did not, nursing victims back to health.[11]” And: “St. Brigid of Sweden (1303-1373) was a Swedish noblewoman, who became a third order Franciscan after the death of her husband. During the rest of her life, she would care for the sick, eventually founding a religious order dedicated to prayer and care for the poor, the Order of the Most Holy Saviour (or the Brigittines). Plague struck Sweden in 1349, as St. Brigid was on pilgrimage to Rome to seek approval for her rule. She arrived in Rome just as the plague attacked the city and the Pope himself had departed… St. Bridget does not speak about the suddenness of death… as only punishment or wrath. Rather, because death comes when we do not expect it, human beings have the freedom to make of their lives a sacrificial offering. They may live an existence of freely bestowed charity. Contingency—including plague—are part of the fall. And rather than be bitter about this, the suddenness of death becomes an occasion for deeper love or the exercise of charity.” And: “St. Charles Borromeo was a saint who followed the example of St. Catherine and St. Bridget. Born in 1538, St. Charles was named a Cardinal of the Catholic Church in his early 20s by his uncle Pope Pius IV. St. Charles was only then ordained a deacon, called to Rome, where he was charged to enact the final session of the Council of Trent (which was continually postponed because of war and plague).[14]St. Charleswas appointed Archbishop of Milan in 1564. The Archbishop of Milan typically did not reside in the city, instead living in Rome. Because of this, the Milanese Church was profoundly corrupt. Clerics had many children. They openly carried swords, functioning akin to feudal lords. It was bad enough that a saying developed in Milan, ‘If you want to go to hell, become a priest.’ ”St. Charles insisted upon living in Milan, where he enacted the reforms of the Council of Trent including the education of clergy, increased promotion of lay holiness, and held regular diocesan and provincial synods. He visited every parish in his diocese, for he knew that the vocation of the bishop was to be present to his people… ”In 1576, plague descended upon Milan. At the time, St. Charles was outside the city, but he rushed home. Almost immediately, St. Charlesentered the Milanese lazarettos, giving Viaticum and anointing the sick. He did so at great personal risk, against the advisement of both public officials and some of his clergy.[15] Because St. Charles knew that the Milanese needed the presence of the Lord in this time, when nearly every ward of the city was in quarantine… St. Charles… responded to the deepest of human need. A desire for presence, especially during sickness. He knew that the Church, if she was to be healed not only from plague but from the corruption internal to her clergy and lay members[17], needed to be in the presence of one another, of the sick and suffering, and of the saints… If plague is to come, then it should lead to deeper holiness, more frequent reflection on the mortality and thereby the contingency of our lives. Eucharistic participation should increase, because frequent reception is what enables us to transform our suffering and death into a space of love.” [emphasis added] *** The Church has never believed that it is in harmony with the Christian faith to divide the members of the Church into two groups, one “pure” and able to receive the sacraments, the other “impure” and forbidden access to the sacraments. The Church is one, and must always be one, and so remain united. This Berlin decision is a very dangerous precedent. This matter should be addressed decisively by Rome as soon as possible. —RM *** Also, Archbishop Viganò prepared a statement on some aspects of these matters on December 2, which was released just this afternoon, here. I will include the text in an upcoming email.=========================== The Archdiocese of Berlin has declared that only the vaccinated or COVID-recovered faithful may attend Holy Mass By Maike Hickson Mon Dec 6, 2021 – 9:09 pm EST (LifeSiteNews) – A group of some 60 Catholics – families, students, and the elderly – have shown their opposition to the new “2G” rule in the Archdiocese of Berlin that only the vaccinated or COVID-recovered faithful may attend Holy Mass. These Catholics organized a prayer vigil at Hedwig’s Cathedral, the main Catholic church in Berlin, singing, praying, and displaying a sign which read: “No 2G: Church for all.” LifeSite interviewed Moritz Scholtysik, one of the organizers of this initiative, which was spontaneously started out of opposition to the Archdiocese of Berlin’s decision. The decision to segregate Catholics based on vaccine status was not even imposed upon the diocese by the state. Since November 27, Holy Mass on Sundays and on feast days are restricted for the unvaccinated. “Due to this decision by the Archdiocese,” Scholtysik told LifeSite, “some faithful were already denied Mass attendance on the first Sunday of Advent. This is disastrous. According to the catechism the faithful do have a right to receive the holy sacraments. Especially in a time when we experience fear, loneliness, and isolation, the common celebration of Holy Mass is more important than ever.” The main organizers of this prayer vigil are five mostly young Catholics from different parishes in the Archdiocese of Berlin, and they know that already many people had written letters of protest to Berlin Archbishop Heiner Koch. After the second prayer vigil yesterday, the group also published a press release (see full text below). “We ask him [Archbishop Koch] to make the celebration of the sacraments accessible to everyone again. In the prayer vigil, therefore, we prayed a rosary for the archbishop and the entire diocese,” co-initiator Giovanni Maria Olivari said in the release. In this interview with LifeSiteNews, Scholtysik stressed that the saints of the Catholic Church give us inspiration on how to deal with health crises such as our current one: “Yet the history of the Church gives us so many examples of saintly women and men, who were taking care of the sick despite high risks for their own health. Moreover they always put God and the souls first. Just to name two: Saint Gregory the Great and Saint Charles Borromeo did not reduce their pastoral care in the times of the pest, but even increased it, because they knew that we – above all – need God. Please see below the full interview: LifeSiteNews: What is your initiative? Moritz Scholtysik: We organize prayer vigils in front of Hedwig’s Cathedral, the main Roman Catholic church in Berlin. We come together with candles and lanterns on the Sundays of Advent to sing hymns and pray the rosary for unrestricted access to church services in Berlin during Advent and Christmas. At our first and second vigil there were over 60 attendants. How did it come that you organized this imitative? Scholtysik: The first prayer vigil was a spontaneous reaction to the decision of the Archdiocese of Berlin to impose “2G“ restrictions on church services on Sundays and feast days as of November 27. This means that only those who have a Covid-19 vaccination or recovery certificate will be admitted to the service. Thankfully there are a few exceptions, but even they have “3G“ restrictions, which means either one is vaccinated, recovered, or has a negative antigen rapid test. It is worth mentioning that this decision was made by the Archdiocese alone, there was no rule by the local government. Due to this decision by the Archdiocese some faithful were already denied Mass attendance on the first Sunday of Advent. This is disastrous. According to the catechism the faithful do have a right to receive the holy sacraments. Especially in a time when we experience fear, loneliness, and isolation, the common celebration of Holy Mass is more important than ever. How many people organized this initiative? Are they young and elderly, differed age groups? Scholtysik: We organizers are a group of five, mostly young Catholics from different parishes in the Archdiocese of Berlin. We already knew each other before these restrictions and when we talked about them, we quickly decided to organize a prayer vigil. At that time there have already been many Catholics in Berlin, who wrote e-mails to the Archdiocese to demonstrate their criticism of the new rule. What are you hoping for with your initiative, and how long will you continue? Scholtysik: First of all, in the prayer vigil we pray for the Archbishop Dr. Heiner Koch and the entire Archdiocese. By standing together and demonstrating unity we ask the Archbishop to make the celebration of the sacraments accessible to everyone again. We will continue with the prayer vigils during Advent and then see, how the Archdiocese will decide on the possibilities to attend Holy Mass. However, it is likely that we will continue praying the rosary publicly regardless from the Archdiocese’s decision, because it is the most beautiful and important sign of faith in times of crisis. Furthermore we got [a] very positive response from the participants so far, which is highly encouraging for us. How do you see the situation in Germany in general? Scholtysik: Sadly the situation in Germany is quite heated. Most parties and members of parliament are now in favor of another lockdown and of a general vaccine mandate, although they have promised several times in the last few months, that both will not happen. Mainstream media usually does not criticize this, but actually denounces anyone who will question this unreasonable behavior. Therefore there is an increasing tension and division in society. Many people fear further restrictions of their freedom. Especially in this situation the guidance and the prayer of the church is very much needed. What is your general assessment of how the Catholic Church in Germany has conducted herself in the corona crisis? Scholtysik: It, of course, depends on the parish. There were many good priests and religious all over Germany taking great care of the faithful during this crisis. We are also very grateful for the bishops having prevented a second ban of the Holy Mass by the government in last year’s autumn. Still there could have been more criticism by the hierarchy of the government and the media spreading so much fear, creating division, and driving so many people into loneliness and depression. Instead of increasing the number of holy Masses, processions, and opportunities for confession many churches were closed, Holy Communion on the tongue was prohibited, and holy water fonts were emptied. Yet the history of the Church gives us so many examples of saintly women and men who were taking care of the sick despite high risks for their own health. Moreover they always put God and the souls first. Just to name two: Saint Gregory the Great and Saint Charles Borromeodid not reduce their pastoral care in the times of the pest, but even increased it, because they knew that we – above all – need God. Do you see a connection between the failure of the Catholic Church in the corona crisis and the current Synodal Path that is taking place in Germany? Scholtysik: Yes. Both developments are characterized by the desire to follow the Zeitgeist [“the spirit if the time” or “the spirit of the age”] instead of applying and defending the principles of the Catholic faith. If German bishops and priests were doing the latter, they would certainly find themselves in opposition to the views, presented in mainstream media and politics, but this would make the Church so much more attractive to so many people, who are desperately looking for a good shepherd right now. Below is the group’s press release: The Faithful Demand: No 2G in Berlin’s diocese Up to 60 participants at prayer vigils in front of Hedwig’s Cathedral in Berlin call for unrestricted access to Catholic services Between 40 and 60 faithful gathered in front of Hedwig’s Cathedral in Berlin on the first two Sundays of Advent with the claim “No 2G: Church for All” (“Kein 2G: Kirche für alle“). Together, the privately initiated group prayed for unrestricted access to Church services during Advent and Christmas. On November 28th and December 5th, the participants gathered at dusk with candles and lanterns, sang the Advent hymn “Macht hoch die Tür” and prayed the rosary. The prayer vigils were a reaction to the decision of the Archdiocese of Berlin to impose 2G restrictions on church services on Sundays as of November 27. This means that only those who have a Covid-19 vaccination or recovery certificate will be admitted to the service. Even the few exceptions have 3G restrictions. Some faithful were already denied Mass attendance on the first Sunday of Advent. Co-initiator Moritz Scholtysik explains: “This decision is disastrous. Especially in a time when we experience fear, loneliness and isolation, the common celebration of Holy Mass is more important than ever.””Even though there are exceptions, a great many faithful are excluded from celebrating Holy Mass. This creates even more division in the Christian community,” co-initiator Ludwig Brühl says. “We thank Archbishop Dr. Heiner Koch for having already eased the restrictions slightly. At the same time, we ask him to make the celebration of the sacraments accessible to everyone again. In the prayer vigil, therefore, we prayed a rosary for the archbishop and the entire diocese,” co-initiator Giovanni Maria Olivari emphasizes. The prayer vigils got a very positive response from the participants. Encouraged by the common action, they wished for a continuation of public prayer.”Dr. Maike Hickson was born and raised in Germany. She holds a PhD from the University of Hannover, Germany, after having written in Switzerland her doctoral dissertation on the history of Swiss intellectuals before and during World War II. She now lives in the U.S. and is married to Dr. Robert Hickson, and they have been blessed with two beautiful children. She is a happy housewife who likes to write articles when time permits. Hickson has closely followed the papacy of Pope Francis and the developments in the Catholic Church in Germany, and she has been writing articles on religion and politics for U.S. and European publications and websites such as LifeSiteNews, OnePeterFive, The Wanderer, Rorate Caeli, Catholicism.org, Catholic Family News, Christian Order, Notizie Pro-Vita, Corrispondenza Romana, Katholisches.info, Der Dreizehnte, Zeit-Fragen, and Westfalen-Blatt.
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Editor’s note: as we announced last week, this is the beginning of an ongoing series presenting both sides of the SSPX debate. This answer to Mr. Salza will also include a general defense of the SSPX. Contributions to this debate on either side can be sent to editor [at] onepeterfive.com.
Recently, John Salza wrote an article attacking Archbishop Lefebvre and the SSPX. Before we reply to John Salza, let us recount the greatness and heroic deeds, the sacrifices, struggles and missionary labors of His Grace, Archbishop Marcel Lefebvre, the holy French Catholic Missionary to Africa, a true Apostle of Jesus Christ Our King. Let us examine the case from the very beginning to see where truth lies.Advertisement – Continue Reading Below
The First Phase of Lefebvre’s Life (1929-1958). Ordained a Priest in 1929 at the age of 23 to preparing for the Second Vatican Council in 1959. The Shining Catholic Missionary who helped grow the Roman Catholic Church in Africa.
In blood, sweat, tears and toil, Archbishop Lefebvre labored for decades, ministering to hundreds of thousands of Catholics, and spreading the missionary work to save souls. Together with Venerable American Archbishop Fulton Sheen, he was one of the greatest Catholic evangelists of the 20th century. His zeal was admired by Pope Pius XII, who elevated him to Vicar Apostolic, overseeing some 50,000 Catholics throughout Africa. His missionary ideas to elevate the nascent African Christendom were later adopted by Pius XII in his encyclical on the missions, Fidei Donum (1957).Advertisement – Continue Reading Below
His missionary efforts have borne the greatest fruits. The Church in Africa today is an amazing success story. As Aleteia notes, and in a completely incredible and unexpected way, there are now more Christians in Africa than in Europe and even Latin America. According to John Allen, “Africa in the twentieth century went from a Catholic population of 1.9 million in 1900 to 130 million in 2000, a growth rate of 6,708 percent, the most rapid expansion of Catholicism in a single continent in two thousand years of church history.”[1]We cannot forget the great African Cardinals who have greatly blessed and enriched the Universal Church: doctrinal and liturgical traditionalist Cardinal Sarah with friends of Tradition like Cardinal Arinze, a supporter of complete rights and full freedom for the Missa Tridentina. God Bless Africa, and may the good Priests, Nuns, Bishops and Cardinals of Africa, along with Lay Catholic Evangelists – vocations are now quite numerous in the continent – continue to bless the Universal Church.
The Second Phase of Archbishop Marcel Lefebvre’s Life (1959-1988) Thirty Glorious Years of Fidelity to Catholic Tradition, and staunch Anti-Communist Catholic Action, amidst opposition and persecution. Catholic Champion of the Rights of Jesus Christ Our King, the Treasure of Tradition, Mary Immaculate as Mediatrix of All Graces, the Fifth Marian Dogma, and a heroic example of nearly blameless and flawless Catholic Devotion to Jesus and Mary before all.
Already in 1966, Archbishop Lefebvre sounded the prophetic warning, with the greatest love and devotion toward the Magisterial Authorities, that a Great Crisis for Christendom was beginning. Do we not recognize, 55 years later, these warnings as absolutely and incredibly prophetic?
The Church’s destruction is proceeding apace. Through an exaggerated authority granted to Episcopal conferences, the Sovereign Pontiff has rendered himself impotent. In a single year, how many painful examples! And yet, the Successor of Peter and he alone can save the Church.
Let the Holy Father surround himself with vigorous defenders of the Faith, let him appoint them to significant dioceses. Let him deign to proclaim the truth in weighty documents, let him hunt down error without fear of opposition, without fear of schism, without fear of casting doubt upon the pastoral dispositions of the Council.
May the Holy Father deign to encourage the bishops to set faith and morals aright individually, as befits any good shepherd; to support courageous bishops, to incite them to reform their seminaries, to reestablish studies according to St. Thomas in them; to encourage superiors general to maintain in their novitiates and communities the fundamental principles of all Christian asceticism, especially obedience; to encourage the development of Catholic schools, of a doctrinally healthy press, of associations of Christian families; at last also to repress those who instigate error and to reduce them to silence. Wednesday allocutions cannot take the place of encyclicals, of commands, of letters to bishops.
Doubtless I am rather bold to express myself in this manner! But it is with ardent love that I write these lines, love of the glory of God, love of Jesus, love of Mary, of her Church, of the Successor of Peter, bishop of Rome, vicar of Jesus Christ.
No wonder Cardinal Oddi said the drama with Archbishop Lefebvre is that he has “too much Faith.” He understood well the treasure of our faith, and thus the treasure of our Tradition.Advertisement – Continue Reading Below
Cardinal Oddi’s words show the Roman Church regards Archbishop Lefebvre as one of Her faithful sons, though he made a few mistakes.
We cannot forget two of perhaps the greatest and strongest traditional Catholic bishops in the Church today, Bishop Athanasius Schneider and Bishop Carlo Maria Vigano, have had words of appreciation, esteem and praise for Archbishop Lefebvre and the Society of St. Pius X.
The Third Phase of Archbishop Lefebvre’s Life (1988-1991): Consecration of Bishops, a few mistakes (everybody is allowed some), and difficulties with Rome under Pope St. John Paul II.
Here, in this third phase of his life, Archbishop Lefebvre was slightly confused by the schismatic sedevacantists. Although he had justly expelled them from his Society in 1983, for the great troubles they caused him, and had clearly taught: “It is very important that there should always be the bond with Rome if we wish to remain Catholic; even if we do not agree with everything being done in Rome, I think the bond is absolutely indispensable.” Now he himself began to be confused by their schismatic claims about Pope St. John Paul II. If only he had given as much attention to many of his priests who were Indult Traditionalists, who later founded St. Peter’s Fraternity. These priests loved and appreciated Pope St. John Paul II, for his own heroic efforts to defeat Communism in the USSR, and fight abortion everywhere in the world, together with travelling to visit the whole world, including India, my own country, to promote the Gospel, the Church, and Catholic Evangelism. I think that if Archbishop Lefebvre had considered these things, he may have more greatly respected Pope St. John Paul II.Advertisement – Continue Reading Below
Indeed, in the early years, Archbishop Lefebvre had the highest appreciation and esteem for Pope St. John Paul II and believed His Holiness was going to help save the Church from the post Vatican-II Crisis in the Church.
For example, in 1978, Archbishop Lefebvre wrote to him:
Holy Father, There is no doubt that the audience you granted me was willed by God. For me it was a great comfort to be able quite freely to explain the circumstances and the grounds for the existence of the Priestly Fraternity of St. Pius X and of its seminaries, and the reasons which led me to continue the Work in spite of the decisions by Fribourg and Rome. It is plain to any impartial observer that our Work is a nursery of priests of the sort the Church has always desired and the true faithful want. We are justified in thinking that if the Church would admit the fact and give it the legality to which it is entitled vocations would be even more plentiful.
Holy Father, for the honor of Jesus Christ, for the good of the Church, for the salvation of souls, we beg you to say a single word as Successor of Peter and Pastor of the Universal Church to the bishops of the whole world: ‘Let them carry on – We authorize the free use of what multisecular Tradition has used for the sanctification of souls.’
What difficulty is there in such an attitude? None. The bishops would decide the places and the times reserved for that Tradition. Unity would be discovered again at once at the level of the bishop of the place. On the other hand, what advantages for the Church: the renewal of seminaries and monasteries, great fervor in the parishes. The bishops would be stupefied to find in a few years an outburst of devotion and sanctification which they thought had disappeared forever.”(!)
Still, on balance, the great works that Archbishop Lefebvre had already accomplished speak for themselves. If Archbishop Lefebvre had gone to Rome, defended his cause, explained his case, and obtained Ordinary Jurisdiction for his Bishops (which, by divine law, can come to Bishops only through the Successor of St. Peter, as Pope Ven. Pius XII teaches), the Truth is that he probably would already have received the crown of canonization by now. That’s what the schismatic sedevacantists have cost His Grace, and why it’s so important to oppose their error. The 1988 Protocol which was signed between Rome and Archbishop Lefebvre, if it had gone through, would have been enough for Canonical Status.
I wish to note as well that His Excellency Bishop Fellay is a true successor of Archbishop Lefebvre. Damsel of the Faith recounted an ordinary incident that showed the great grace, humility and longsuffering of this traditional Catholic Bishop, during a Confirmation:
Nobody who was in that room is likely to forget what happened next: Bishop Fellay came in, with his as yet untreated foot – which turned out to have been seriously broken – on crutches, and with a big smile on his face! After first apologizing for the ‘inconvenience’ (!) his injury had caused, Fellay then suddenly said, with an even bigger smile: ‘This is a very good sign! It is a very good sign, because it shows that the devil is very angry that these little children receive the Sacrament of Confirmation!’ The faithful present were astonished. How was it that this holy man smiled through the pain of a broken foot and yet rejoiced over obstacles put into his way?
In addition, the SSPX has now done two great things that no other traditional Catholic fraternity, including the FSSP, the SSPV, the Resistance (all three groups that split off from the SSPX to go their own separate ways), the CMRI, the ICK and every other group (there are too many schisms in Tradition today, and too little focus on unity and charity). They’ve “graduated” Roman Catholic Bishops to Roman Catholic Tradition. And they’ve done it not only once but even twice! Alleluia! Bishop Lazo of the Philippines is the first, and we leave it to our readers to research and do their homework on His Excellency. We will mention the great work the SSPX did much more recently, in obtaining, by God’s Grace, that Bishop Huonder should not only want to offer the Traditional Latin Mass, but never again wish to offer the Novus Ordo Mass, according to His Excellency’s own words!
[Interviewer:] May I conclude from your remarks that you no longer wish to celebrate the Novus Ordo at all?
[His Excellency Bishop Huonder]I no longer want to do it. I sense simply that I can no longer do it, because when you are immersed in the traditional Mass, you simply come to a point where you sense that you can no longer do anything else.
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Now, we will come to the objections of Mr. Salza and the answers to them.
Fact I: His Holiness Pope Francis has authorized the SSPX to continue legally and licitly ordaining Priests, even without requesting permission from local Bishops (which, in some cases, they do anyway, and they always respect the Bishops, the Shepherds of the Church).
Bishops of the Society of St. Pius X (SSPX) have been authorized by Pope Francis to ordain new priests without the approval of the local diocesan bishop, according to Bishop Bernard Fellay, the superior of the traditionalist group.
‘Last year, I received a letter from Rome, telling me you can freely ordain your priests without the permission of the local ordinary,’ Bishop Fellay reported. He said that the move indicated that although the status of the SSPX remains irregular, ‘the ordination is recognized by the Church not just as valid but in order.’
The SSPX has been involved in talks with the Vatican, aimed at regularizing the status of the group, and informed sources have indicated that an agreement is close to establish the SSPX as a personal prelature. Pope Francis has already said that SSPX priests have the authority to hear sacramental confessions and preside at weddings that will be recognized by the Catholic Church. Bishop Fellay remarked that the permission to ordain bishops is ‘one more step in his acceptance that we are… “normal Catholics.”
Therefore, the Pope recognizes that the ministration of the Sacraments by the SSPX Bishops is both valid and licit. If even Priestly Ordinations are recognized as being not only valid but also “in order,” then so much more are the other Sacraments. And all this is impossible unless the SSPX already has some kind of canonical mission, even if it is, as yet, not absolutely indisputable, and granted in writing like it was to St. Peter’s Fraternity.Advertisement – Continue Reading Below
Fact II: His Holiness Pope Francis clearly declared, during his Holy Year of Divine Mercy, that SSPX Priests are granted the faculty to absolve validly and licitly, and then, in a generous and gracious gesture, indefinitely extended these faculties after the Holy Year was concluded.
At the close of the Jubilee Year of Mercy, the Holy Father made special mention of the SSPX priests’ faculty to absolve sins.
On Monday, November 21st, 2016, the Vatican released an Apostolic Letter from Pope Francis called Misericordia et Misera. Of note to our readers, the Society of St. Pius X was mentioned in paragraph 12:
For the Jubilee Year I had also granted that those faithful who, for various reasons, attend churches officiated by the priests of the Priestly Fraternity of Saint Pius X, can validly and licitly receive the sacramental absolution of their sins. For the pastoral benefit of these faithful, and trusting in the good will of their priests to strive with God’s help for the recovery of full communion with the Catholic Church, I have personally decided to extend this faculty beyond the Jubilee Year, until further provisions are made, lest anyone ever be deprived of the sacramental sign of reconciliation through the Church’s pardon.
Thank you Holy Father! The SSPX should be more grateful to Pope Francis for his generous steps toward them, to reconcile them to full communion. One sees often that some among the SSPX – usually laity more than Priests – have contempt for the Holy Father and refer to him, with derision, as “Mr. Bergoglio,” (another bad practice that comes from the schismatic sedevacantists). This anti-clericalist attitude is not good, and does not come from true devotion or genuine piety. We can disagree with the Vicar of Christ, but we must do so respectfully and with charity toward the Holy Father.
When we speak contemptuously and derisively of the Holy Father, even Catholic Bishops who earlier were favorable to Tradition begin to be negatively disposed toward it. We must fight for the rights of Tradition to be recognized in Rome, but respectfully as Archbishop Lefebvre did.Advertisement – Continue Reading Below
Bishop Fellay said, about this generous gesture of Pope Francis:
As a result of the Pope’s act, during the Holy Year, we will have ordinary jurisdiction. In the image I mentioned, this has the effect of giving us the official insignia of firefighters, whereas such a status was denied us for decades. In itself, it adds nothing new for the Society, its members, or its faithful. Yet this ordinary jurisdiction will perhaps reassure people who are uneasy or others who until now did not dare to approach us. For, as we said in the communiqué thanking the Pope, the priests of the Society wish for one thing only: ‘To perform with renewed generosity their ministry in the confessional, following the example of untiring devotion that the saintly Curé of Ars gave to all priests.’
The SSPX’s sacramental actions are clearly already recognized as valid and licit. Getting full and indisputable canonical mission, preferably in writing like the 1988 Protocol, would complete it.
Fact III: Pope Francis, while still Cardinal Jorge Mario, clearly said to the SSPX Priests, in Argentina: “You are Catholic. That is evident. I will help you.” The truth is both Pope St. John Paul II and Pope Benedict XVI worked hard to grant the Society a canonical status, and perhaps Pope Francis could complete the task, if the Society desires and asks for it.
Pope Francis said some 30 years ago to Fr. Christian of the SSPX:
And the Cardinal [the current Pope Francis] told us, ‘No, no, you are Catholic, that is evident; I will help you.’ He wrote a letter in our favor to the government, that is so leftwing that they managed to find an opposing letter by the nuncio. Therefore, a 0-0 tie. Now he is the pope, and our lawyer had the opportunity of having a meeting with the Pope. He told him that the problem was still going on with the Society, and asked him to please designate a bishop in Argentina with whom we could sort out this problem. The Pope told him, ‘Yes, and this bishop is myself, I promised to help, and I will do it.’
Now reportedly Cardinal Ratzinger said of Archbishop Lefebvre in 2003: “I consider him to be the most important bishop of the 20th century with regard to the universal Church.” Further, he directly addressed Mr. Salza’s critique when he said:
From my current point of view, I have to agree with Archbishop Lefebvre in retrospect about having his own bishops. Today after the experience of ’15 years of Ecclesia Dei,’ it is clear that such a work as that of the Priestly Fraternity of St. Pius X cannot simply be handed over to the diocesan bishops.
***
Reverend Fathers of the SSPX, John Salza, whose book you endorsed, and who frequented Society chapels for over a decade, is now attacking the Society for lacking canonical status.
Although some of his claims are clearly mistaken, just think, beside the theological reasons why canonical mission is necessary, how many practical advantages and blessings it would bring both to the SSPX and to all Catholic Tradition. Continue to advocate for Tradition and defend its cause in Rome and the wider Church, just like Archbishop Lefebvre so rightly did, and as you are so nobly continuing to do. But also, now that fifty years have passed since you were founded as a canonically regular society, and about thirty since Archbishop Lefebvre came very close to canonical normalization with Rome, please understand why so many Catholics who love and support you with all their strength, who pray for and donate to your apostolate, believe it would be better and preferable for you to obtain canonical normalization. If the Pope himself said the Society is canonically regular, all the Bishops of the Church would be absolutely obliged to accept it. And it is very probable that most of them will.
The SSPX has already grown to nearly 700 Priests. It can easily cross 1000 and even surpass 1500 soon, but it will do all that much faster if it has canonical status first, like St. Peter’s Fraternity. As we saw earlier, Archbishop Lefebvre lobbied for an “as-is” canonical regularization with Rome many times in His Grace’s letters. When more traditional Catholics can work within the canonical structure of the Church, the Latin Mass can be definitively restored and strengthened, for the good of souls.
The SSPX can do the same even today, bring the case to a happy conclusion, and silence the mouths of all misguided objectors like John Salza once and for all. Deus Vult! God wills it!
[1] John Allen cited in Philip Jenkins, The Next Christendom(Oxford University Press: 2011), 72-73. Cf. John Allen, The Future Church (New York: Doubleday, 2009).
Nishant Xavier lives in Chennai, India. He has an MBA in Financial Management and works in investment banking in Credit Suisse. He earlier worked at Bank of New York in its Chennai office. He makes time to preach the Gospel. His Passion is to preach to 100 Crore Souls before he dies. He is the Author of the upcoming Book: The Great Commission of Lord Jesus Christ: Distributing 150 Crore Bibles in India by 2033. For any important concern, send him a mail at nishantxavier2019@gmail.com or connect with him on Facebook, Twitter or LinkedIn and YouTube.
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(LifeSiteNews) – A group of some 60 Catholics – families, students, and the elderly – have shown their opposition to the new “2G” rule in the Archdiocese of Berlin that only the vaccinated or COVID-recovered faithful may attend Holy Mass. These Catholics organized a prayer vigil at Hedwig’s Cathedral, the main Catholic church in Berlin, singing, praying, and displaying a sign which read: “No 2G: Church for all.”
LifeSite interviewed Moritz Scholtysik, one of the organizers of this initiative, which was spontaneously started out of opposition to the Archdiocese of Berlin’s decision. The decision to segregate Catholics based on vaccine status was not even imposed upon the diocese by the state. Since November 27, Holy Mass on Sundays and on feast days are restricted for the unvaccinated.
“Due to this decision by the Archdiocese,” Scholtysik told LifeSite, “some faithful were already denied Mass attendance on the first Sunday of Advent. This is disastrous. According to the catechism the faithful do have a right to receive the holy sacraments. Especially in a time when we experience fear, loneliness, and isolation, the common celebration of Holy Mass is more important than ever.”
The main organizers of this prayer vigil are five mostly young Catholics from different parishes in the Archdiocese of Berlin, and they know that already many people had written letters of protest to Berlin Archbishop Heiner Koch. After the second prayer vigil yesterday, the group also published a press release (see full text below).
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“We ask him [Archbishop Koch] to make the celebration of the sacraments accessible to everyone again. In the prayer vigil, therefore, we prayed a rosary for the archbishop and the entire diocese,” co-initiator Giovanni Maria Olivari said in the release.
In this interview with LifeSiteNews, Scholtysik stressed that the saints of the Catholic Church give us inspiration on how to deal with health crises such as our current one:
Yet the history of the church gives us so many examples of saintly women and men, who were taking care of the sick despite high risks for their own health. Moreover they always put God and the souls first. Just to name two: Saint Gregory the Great and Saint Charles Borromeo did not reduce their pastoral care in the times of the pest, but even increased it, because they knew that we – above all – need God.
Please see below the full interview:
LifeSiteNews: What is your initiative?
Moritz Scholtysik: We organize prayer vigils in front of Hedwig’s Cathedral, the main Roman Catholic church in Berlin. We come together with candles and lanterns on the Sundays of Advent to sing hymns and pray the rosary for unrestricted access to church services in Berlin during Advent and Christmas. At our first and second vigil there were over 60 attendants.
How did it come that you organized this imitative?
The first prayer vigil was a spontaneous reaction to the decision of the Archdiocese of Berlin to impose “2G“ restrictions on church services on Sundays and feast days as of November 27. This means that only those who have a Covid-19 vaccination or recovery certificate will be admitted to the service. Thankfully there are a few exceptions, but even they have “3G“ restrictions, which means either one is vaccinated, recovered, or has a negative antigen rapid test. It is worth mentioning that this decision was made by the Archdiocese alone, there was no rule by the local government.
Due to this decision by the Archdiocese some faithful were already denied Mass attendance on the first Sunday of Advent. This is disastrous. According to the catechism the faithful do have a right to receive the holy sacraments. Especially in a time when we experience fear, loneliness, and isolation, the common celebration of Holy Mass is more important than ever.
How many people organized this initiative? Are they young and elderly, differed age groups?
We organizers are a group of five, mostly young Catholics from different parishes in the Archdiocese of Berlin. We already knew each other before these restrictions and when we talked about them, we quickly decided to organize a prayer vigil. At that time there have already been many Catholics in Berlin, who wrote e-mails to the Archdiocese to demonstrate their criticism of the new rule.
What are you hoping for with your initiative, and how long will you continue?
First of all, in the prayer vigil we pray for the Archbishop Dr. Heiner Koch and the entire Archdiocese. By standing together and demonstrating unity we ask the Archbishop to make the celebration of the sacraments accessible to everyone again. We will continue with the prayer vigils during Advent and then see, how the Archdiocese will decide on the possibilities to attend Holy Mass.
However, it is likely that we will continue praying the rosary publicly regardless from the Archdiocese’s decision, because it is the most beautiful and important sign of faith in times of crisis. Furthermore we got [a] very positive response from the participants so far, which is highly encouraging for us.
How do you see the situation in Germany in general?
Sadly the situation in Germany is quite heated. Most parties and members of parliament are now in favor of another lockdown and of a general vaccine mandate, although they have promised several times in the last few months, that both will not happen. Mainstream media usually does not criticize this, but actually denounces anyone who will question this unreasonable behavior. Therefore there is an increasing tension and division in society. Many people fear further restrictions of their freedom. Especially in this situation the guidance and the prayer of the church is very much needed.
What is your general assessment of how the Catholic Church in Germany has conducted herself in the corona crisis?
It, of course, depends on the parish. There were many good priests and religious all over Germany taking great care of the faithful during this crisis. We are also very grateful for the bishops having prevented a second ban of the Holy Mass by the government in last year’s autumn.
Still there could have been more criticism by the hierarchy of the government and the media spreading so much fear, creating division, and driving so many people into loneliness and depression. Instead of increasing the number of holy Masses, processions, and opportunities for confession many churches were closed, Holy Communion on the tongue was prohibited, and holy water fonts were emptied.
Yet the history of the church gives us so many examples of saintly women and men who were taking care of the sick despite high risks for their own health. Moreover they always put God and the souls first. Just to name two: Saint Gregory the Great and Saint Charles Borromeo did not reduce their pastoral care in the times of the pest, but even increased it, because they knew that we – above all – need God.
Do you see a connection between the failure of the Catholic Church in the corona crisis and the current Synodal Path that is taking place in Germany?
Yes. Both developments are characterized by the desire to follow the Zeitgeist instead of applying and defending the principles of the Catholic faith. If German bishops and priests were doing the latter, they would certainly find themselves in opposition to the views, presented in mainstream media and politics, but this would make the Church so much more attractive to so many people, who are desperately looking for a good shepherd right now.
Below is the group’s press release:
Faithful demand: No 2G in Berlin’s diocese
Up to 60 participants at prayer vigils in front of Hedwig‘s Cathedral in Berlin
Call for unrestricted access to Catholic services
Between 40 and 60 faithful gathered in front of Hedwig’s Cathedral in Berlin on the first two Sundays of Advent with the claim “No 2G: Church for All” (“Kein 2G: Kirche für alle“). Together, the privately initiated group prayed for unrestricted access to church services during Advent and Christmas.
On November 28th and December 5th the participants gathered at dusk with candles and lanterns, sang the Advent hymn “Macht hoch die Tür” and prayed the rosary.
The prayer vigils were a reaction to the decision of the Archdiocese of Berlin to impose 2G restrictions on church services on Sundays as of November 27. This means that only those who have a Covid-19 vaccination or recovery certificate will be admitted to the service. Even the few exceptions have 3G restrictions. Some faithful were already denied Mass attendance on the first Sunday of Advent.
Co-initiator Moritz Scholtysik explains: “This decision is disastrous. Especially in a time when we experience fear, loneliness and isolation, the common celebration of Holy Mass is more important than ever.”
“Even though there are exceptions, a great many faithful are excluded from celebrating Holy Mass. This creates even more division in the Christian community,” co-initiator Ludwig Brühl says.
“We thank Archbishop Dr. Heiner Koch for having already eased the restrictions slightly. At the same time, we ask him to make the celebration of the sacraments accessible to everyone again. In the prayer vigil, therefore, we prayed a rosary for the archbishop and the entire diocese,” co-initiator Giovanni Maria Olivari emphasizes. The prayer vigils got a very positive response from the participants. Encouraged by the common action, they wished for a continuation of public prayer.
Dr. Maike Hickson was born and raised in Germany. She holds a PhD from the University of Hannover, Germany, after having written in Switzerland her doctoral dissertation on the history of Swiss intellectuals before and during World War II. She now lives in the U.S. and is married to Dr. Robert Hickson, and they have been blessed with two beautiful children. She is a happy housewife who likes to write articles when time permits.
Dr. Hickson published in 2014 a Festschrift, a collection of some thirty essays written by thoughtful authors in honor of her husband upon his 70th birthday, which is entitled A Catholic Witness in Our Time.
Hickson has closely followed the papacy of Pope Francis and the developments in the Catholic Church in Germany, and she has been writing articles on religion and politics for U.S. and European publications and websites such as LifeSiteNews, OnePeterFive, The Wanderer, Rorate Caeli, Catholicism.org, Catholic Family News, Christian Order, Notizie Pro-Vita, Corrispondenza Romana, Katholisches.info, Der Dreizehnte, Zeit-Fragen, and Westfalen-Blatt.TOPICS
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
Report Prepared by: Worldwide Safety Pfizer
The information contained in this document is proprietary and confidential. Any disclosure, reproduction, distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensees, or Regulatory Agencies is strictly prohibited. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except where required by applicable law), nor to use it for unauthorized purposes.
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TABLE OF CONTENTS
LIST OF TABLES………………………………………………………………………………………………………3 LIST OF FIGURES …………………………………………………………………………………………………….3 APPENDICES ……………………………………………………………………………………………………………3 LIST OF ABBREVIATIONS……………………………………………………………………………………….4 1. INTRODUCTION …………………………………………………………………………………………………..5 2. METHODOLOGY ………………………………………………………………………………………………….5 3. RESULTS ………………………………………………………………………………………………………………6
3.1. Safety Database ……………………………………………………………………………………………6 3.1.1. General Overview……………………………………………………………………………..6 3.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan ……………9 3.1.3. Review of Adverse Events of Special Interest (AESIs) ………………………..16 3.1.4. Medication error ……………………………………………………………………………..26
4. DISCUSSION ……………………………………………………………………………………………………….28 5. SUMMARY AND CONCLUSION …………………………………………………………………………29
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General Overview: Selected Characteristics of All Cases Received During the Reporting Interval……………………………………………………………7
Events Reported in ≥2% Cases ………………………………………………………….8 Safety concerns ……………………………………………………………………………….9 Important Identified Risk………………………………………………………………..10 Important Potential Risk…………………………………………………………………11 Description of Missing Information …………………………………………………12 AESIs Evaluation for BNT162b2 …………………………………………………….16 ME PTs by seriousness with or without harm co-association
(Through 28 February 2021) …………………………………………………………..27
LIST OF FIGURES
Total Number of 13vPnC AEs by System Organ Classes and Event Seriousness …………………………………………………………………………………….8
APPENDICES
APPENDIX 1 LIST OF ADVERSE EVENTS OF SPECIAL INTEREST ……………………….30
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LIST OF ABBREVIATIONS
Acronym Term
AE adverse event AESI adverse event of special interest BC Brighton Collaboration CDC Centers for Disease Control and Prevention COVID-19 coronavirus disease 2019 DLP data lock point EUA emergency use authorisation HLGT (MedDRA) High Group Level Term HLT (MedDRA) High Level Term MAH marketing authorisation holder MedDRA medical dictionary for regulatory activities MHRA Medicines and Healthcare products Regulatory Agency PCR Polymerase Chain Reaction PT (MedDRA) Preferred Term PVP pharmacovigilance plan RT-PCR Reverse Transcription-Polymerase Chain Reaction RSI reference safety information TME targeted medically event SARS-CoV-2 severe acute respiratory syndrome coronavirus 2 SMQ standardised MedDRA query SOC (MedDRA) System Organ Class UK United Kingdom US United States VAED vaccine-associated enhanced disease VAERD vaccine-associated enhanced respiratory disease VAERS vaccine adverse event reporting system
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1. INTRODUCTION
Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech’s proposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for our investigational COVID-19 Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to this request, and specifically, the following request from the Agency.
“Monthly safety reports primarily focus on events that occurred during the reporting interval and include information not relevant to a BLA submission such as line lists of adverse events by country. We are most interested in a cumulative analysis of post-authorization safety data to support your future BLA submission. Please submit an integrated analysis of your cumulative post-authorization safety data, including U.S. and foreign post-authorization experience, in your upcoming BLA submission. Please include a cumulative analysis of the Important Identified Risks, Important Potential Risks, and areas of Important Missing Information identified in your Pharmacovigilance Plan, as well as adverse events of special interest and vaccine administration errors (whether or not associated with an adverse event). Please also include distribution data and an analysis of the most common adverse events. In addition, please submit your updated Pharmacovigilance Plan with your BLA submission.”
This document provides an integrated analysis of the cumulative post-authorization safety data, including U.S. and foreign post-authorization adverse event reports received through 28 February 2021.
2. METHODOLOGY
Pfizer is responsible for the management post-authorization safety data on behalf of the MAH BioNTech according to the Pharmacovigilance Agreement in place. Data from BioNTech are included in the report when applicable.
Pfizer’s safety database contains cases of AEs reported spontaneously to Pfizer, cases reported by the health authorities, cases published in the medical literature, cases from Pfizer-sponsored marketing programs, non-interventional studies, and cases of serious AEs reported from clinical studies regardless of causality assessment.
The limitations of post-marketing adverse drug event reporting should be considered when interpreting these data:
Reports are submitted voluntarily, and the magnitude of underreporting is unknown. Some of the factors that may influence whether an event is reported include: length of time since marketing, market share of the drug, publicity about a drug or an AE, seriousness of the reaction, regulatory actions, awareness by health professionals and consumers of adverse drug event reporting, and litigation.
Because many external factors influence whether or not an AE is reported, the spontaneous reporting system yields reporting proportions not incidence rates. As a result, it is generally not appropriate to make between-drug comparisons using these
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proportions; the spontaneous reporting system should be used for signal detection rather than hypothesis testing.
In some reports, clinical information (such as medical history, validation of diagnosis, time from drug use to onset of illness, dose, and use of concomitant drugs) is missing or incomplete, and follow-up information may not be available.
An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AE was caused by the drug; rather, the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication.
• Among adverse event reports received into the Pfizer safety database during the cumulative period, only those having a complete workflow cycle in the safety database (meaning they progressed to Distribution or Closed workflow status) are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information. Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity. The increased volume of reports has not impacted case processing for serious reports, and compliance metrics continue to be monitored weekly with prompt action taken as needed to maintain compliance with expedited reporting obligations. Non-serious cases are entered into the safety database no later than 4 calendar days from receipt. Entrance into the database includes the coding of all adverse events; this allow for a manual review of events being received but may not include immediate case processing to completion. Non-serious cases are processed as soon as possible and no later than 90 days from receipt. Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately (b) (4) additional full- time employees (FTEs). More are joining each month with an expected total of more than (b) (4) additional resources by the end of June 2021.
3. RESULTS 3.1. Safety Database 3.1.1. General Overview
It is estimated that approximately (b) (4) doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.
Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866) and Spain (756); the remaining 7,324 were distributed among 56 other countries.
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Table 1 below presents the main characteristics of the overall cases.
Table 1.
Gender:
Case outcome:
General Overview: Selected Characteristics of All Cases Received During the Reporting Interval
Characteristics
Female Male No Data
Recovered/Recovering Recovered with sequelae Not recovered at the time of report Fatal Unknown
Relevant cases (N=42086)
29914
9182
2990
19582
520
11361
1223
9400
Age range (years): 0.01 -107 years Mean = 50.9 years n = 34952
≤ 17 18-30 31-50 51-64 65-74 ≥ 75 Unknown
175a 4953 13886 7884 3098 5214 6876
a. in 46 cases reported age was <16-year-old and in 34 cases <12-year-old.
As shown in Figure 1, the System Organ Classes (SOCs) that contained the greatest number (≥2%) of events, in the overall dataset, were General disorders and administration site conditions (51,335 AEs), Nervous system disorders (25,957), Musculoskeletal and connective tissue disorders (17,283), Gastrointestinal disorders (14,096), Skin and subcutaneous tissue disorders (8,476), Respiratory, thoracic and mediastinal disorders (8,848), Infections and infestations (4,610), Injury, poisoning and procedural complications (5,590), and Investigations (3,693).
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Figure 1. Total Number of BNT162b2 AEs by System Organ Classes and Event Seriousness
Table 2 shows the most commonly (≥2%) reported MedDRA (v. 23.1) PTs in the overall dataset (through 28 February 2021),
Table 2. Events Reported in ≥2% Cases
MedDRA SOC
Blood and lymphatic system disorders
Cardiac disorders Gastrointestinal disorders
MedDRA PT
Lymphadenopathy Tachycardia
Nausea Diarrhoea Vomiting
Cumulatively Through 28 February 2021 AEs (AERP%) N = 42086
3.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan Table 3. Safety concerns
Important identified risks Important potential risks Missing information
Anaphylaxis
Vaccine-Associated Enhanced Disease (VAED), Including Vaccine-associated Enhanced Respiratory Disease (VAERD)
Use in Pregnancy and lactation Use in Paediatric Individuals <12 Years of Age Vaccine Effectiveness
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Table 4. Topic
Important Identified Risk
Important Identified Risk
Description
Post Authorization Cases Evaluation (cumulative to 28 Feb 2021) Total Number of Cases in the Reporting Period (N=42086)
Anaphylaxis
Since the first temporary authorization for emergency supply under Regulation 174 in the UK (01 December 2020) and through 28 February 2021, 1833 potentially relevant cases were retrieved from the Anaphylactic reaction SMQ (Narrow and Broad) search strategy, applying the MedDRA algorithm. These cases were individually reviewed and assessed according to Brighton Collaboration (BC) definition and level of diagnostic certainty as shown in the Table below:Brighton Collaboration Level BC1 BC2 BC3BC4 BC5 Total Level 1 indicates a case with the highest level of diagnostic certainty of anaphylaxis, whereas the diagnostic certainty is lowest for Level 3. Level 4 is defined as “reported event of anaphylaxis with insufficient evidence to meet the case definition” and Level 5 as not a case of anaphylaxis.There were 1002 cases (54.0% of the potentially relevant cases retrieved), 2958 potentially relevant events, from the Anaphylactic reaction SMQ (Broad and Narrow) search strategy, meeting BC Level 1 to 4:Country of incidence: UK (261), US (184), Mexico (99), Italy (82), Germany (67), Spain (38), France (36), Portugal (22), Denmark (20), Finland, Greece (19 each), Sweden (17), Czech Republic , Netherlands (16 each), Belgium, Ireland (13 each), Poland (12), Austria (11); the remaining 57 cases originated from 15 different countries.Relevant event seriousness: Serious (2341), Non-Serious (617); Gender: Females (876), Males (106), Unknown (20); Age (n=961) ranged from 16 to 98 years (mean = 54.8 years, median = 42.5 years); Relevant even outcomea: fatal (9)b, resolved/resolving (1922), not resolved (229), resolved with sequelae (48), unknown (754); Most frequently reported relevant PTs (≥2%), from the Anaphylactic reaction SMQ (Broad and Narrow) search strategy: Anaphylactic reaction (435), Dyspnoea (356), Rash (190), Pruritus (175), Erythema (159), Urticaria (133), Cough (115), Respiratory distress, Throat tightness (97 each), Swollen tongue (93), Anaphylactic shock (80), Hypotension (72), Chest discomfort (71), Swelling face (70), Pharyngeal swelling (68), and Lip swelling (64).Conclusion: Evaluation of BC cases Level 1 – 4 did not reveal any significant new safety information. Anaphylaxis is appropriately described in the product labeling as are non-anaphylactic hypersensitivity events. Surveillance will continue.Number of cases 290 311 10391 831 1833
a b Although these patients experienced adverse events (9) that are potential symptoms of anaphylaxis, they all had serious underlying medical conditions, and one individual appeared to also have COVID-19 pneumonia, that likely contributed to their deaths
Different clinical outcome may be reported for an event that occurred more than once to the same individual. There were 4 individuals in the anaphylaxis evaluation who died on the same day they were vaccinated.
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 5. Topic
Important Potential Risk
Important Potential Risk
Description
Post Authorization Cases Evaluation (cumulative to 28 Feb 2021) Total Number of Cases in the Reporting Period (N=42086)
No post-authorized AE reports have been identified as cases of VAED/VAERD, therefore, there is no observed data at this time. An expected rate of VAED is difficult to establish so a meaningful observed/expected analysis cannot be conducted at this point based on available data. The feasibility of conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the vaccine safety data continues to accrue.The search criteria utilised to identify potential cases of VAED for this report includes PTs indicating a lack of effect of the vaccine and PTs potentially indicative of severe or atypical COVID-19a.Since the first temporary authorization for emergency supply under Regulation 174 in the UK (01 December 2020) and through 28 February 2021, 138 cases [0.33% of the total PM dataset], reporting 317 potentially relevant events were retrieved:Country of incidence: UK (71), US (25), Germany (14), France, Italy, Mexico, Spain, (4 each), Denmark (3); the remaining 9 cases originated from 9 different countries; Cases Seriousness: 138; Seriousness criteria for the total 138 cases: Medically significant (71, of which 8 also serious for disability), Hospitalization required (non-fatal/non-life threatening) (16, of which 1 also serious for disability), Life threatening (13, of which 7 were also serious for hospitalization), Death (38).Gender: Females (73), Males (57), Unknown (8); Age (n=132) ranged from 21 to 100 years (mean = 57.2 years, median = 59.5); Case outcome: fatal (38), resolved/resolving (26), not resolved (65), resolved with sequelae (1), unknown (8); Of the 317 relevant events, the most frequently reported PTs (≥2%) were: Drug ineffective (135), Dyspnoea (53), Diarrhoea (30), COVID-19 pneumonia (23), Vomiting (20), Respiratory failure (8), and Seizure (7).Conclusion: VAED may present as severe or unusual clinical manifestations of COVID-19. Overall, there were 37 subjects with suspected COVID-19 and 101 subjects with confirmed COVID-19 following one or both doses of the vaccine; 75 of the 101 cases were severe, resulting in hospitalisation, disability, life-threatening consequences or death. None of the 75 cases could be definitively considered as VAED/VAERD.In this review of subjects with COVID-19 following vaccination, based on the current evidence, VAED/VAERD remains a theoretical risk for the vaccine. Surveillance will continue.
Acute kidney injury; Renal failure; Altered state of consciousness; Seizure; Encephalopathy; Meningitis; Cerebrovascular accident; Thrombocytopenia; Disseminated intravascular coagulation; Chillblains; Erythema multiforme; Multiple organ dysfunction syndrome; Multisystem inflammatory syndrome in children.
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 6. Topic
Missing Information
Description of Missing Information Description
Post Authorization Cases Evaluation (cumulative to 28 Feb 2021) Total Number of Cases in the Reporting Period (N=42086)
Use in Pregnancy and lactation
Number of cases: 413a (0.98% of the total PM dataset); 84 serious and 329 non-serious;Country of incidence: US (205), UK (64), Canada (31), Germany (30), Poland (13), Israel(11); Italy (9), Portugal (8), Mexico (6), Estonia, Hungary and Ireland, (5 each), Romania (4), Spain (3), Czech Republic and France (2 each), the remaining 10 cases were distributed among 10 other countries.Pregnancy cases: 274 cases including:270 mother cases and 4 foetus/baby cases representing 270 unique pregnancies (the 4 foetus/baby cases were linked to 3 mother cases; 1 mother case involved twins).Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each). No outcome was provided for 238 pregnancies (note that 2 different outcomes were reported for each twin, and both were counted).146 non-serious mother cases reported exposure to vaccine in utero without the occurrence of any clinical adverse event. The exposure PTs coded to the PTs Maternal exposure during pregnancy (111), Exposure during pregnancy (29) and Maternal exposure timing unspecified (6). Trimester of exposure was reported in 21 of these cases: 1st trimester (15 cases), 2nd trimester (7), and 3rd trimester (2).124 mother cases, 49 non-serious and 75 serious, reported clinical events, which occurred in the vaccinated mothers. Pregnancy related events reported in these cases coded to the PTs Abortion spontaneous (25), Uterine contraction during pregnancy, Premature rupture of membranes, Abortion, Abortion missed, and Foetal death (1 each). Other clinical events which occurred in more than 5 cases coded to the PTs Headache (33), Vaccination site pain (24), Pain in extremity and Fatigue (22 each), Myalgia and Pyrexia (16 each), Chills (13) Nausea (12), Pain (11), Arthralgia (9), Lymphadenopathy and Drug ineffective (7 each), Chest pain, Dizziness and Asthenia (6 each), Malaise and COVID-19 (5 each). Trimester of exposure was reported in 22 of these cases: 1st trimester (19 cases), 2nd trimester (1 case), 3rd trimester (2 cases).4 serious foetus/baby cases reported the PTs Exposure during pregnancy, Foetal growth restriction, Maternal exposure during pregnancy, Premature baby (2 each), and Death neonatal (1). Trimester of exposure was reported for 2 cases (twins) as occurring during the 1st trimester.Breast feeding baby cases: 133, of which:116 cases reported exposure to vaccine during breastfeeding (PT Exposure via breast milk) without the occurrence of any clinical adverse events;17 cases, 3 serious and 14 non-serious, reported the following clinical events that occurred in the infant/child exposed to vaccine via breastfeeding: Pyrexia (5), Rash (4), Infant irritability (3), Infantile vomiting, Diarrhoea, Insomnia, and Illness (2 each), Poor feeding infant, Lethargy, Abdominal discomfort, Vomiting, Allergy to vaccine, Increased appetite, Anxiety, Crying, Poor quality sleep, Eructation, Agitation, Pain and Urticaria (1 each).Breast feeding mother cases (6):1 serious case reported 3 clinical events that occurred in a mother during breast feeding (PTMaternal exposure during breast feeding); these events coded to the PTs Chills, Malaise, andPyrexia1 non-serious case reported with very limited information and without associated AEs.
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 6. Topic
Missing Information
Description of Missing Information Description
Post Authorization Cases Evaluation (cumulative to 28 Feb 2021) Total Number of Cases in the Reporting Period (N=42086)
• In 4 cases (3 non-serious; 1 serious) Suppressed lactation occurred in a breast feeding women with the following co-reported events: Pyrexia (2), Paresis, Headache, Chills, Vomiting, Pain in extremity, Arthralgia, Breast pain, Scar pain, Nausea, Migraine, Myalgia, Fatigue and Breast milk discolouration (1 each).Conclusion: There were no safety signals that emerged from the review of these cases of use in pregnancy and while breast feeding.
Use in Paediatric Individuals <12 Years of Age
Paediatric individuals <12 years of ageNumber of cases: 34d (0.1% of the total PM dataset), indicative of administration in paediatricsubjects <12 years of age;Country of incidence: UK (29), US (3), Germany and Andorra (1 each);Cases Seriousness: Serious (24), Non-Serious (10);Gender: Females (25), Males (7), Unknown (2);Age (n=34) ranged from 2 months to 9 years, mean = 3.7 years, median = 4.0;Case outcome: resolved/resolving (16), not resolved (13), and unknown (5).Of the 132 reported events, those reported more than once were as follows: Productadministered to patient of inappropriate age (27, see Medication Error), Off label use (11), Pyrexia (6), Product use issue (5), Fatigue, Headache and Nausea (4 each), Vaccination site pain (3), Abdominal pain upper, COVID-19, Facial paralysis, Lymphadenopathy, Malaise, Pruritus and Swelling (2 each).Conclusion: No new significant safety information was identified based on a review of these cases compared with the non-paediatric population.
Vaccine Effectiveness
Company conventions for coding cases indicative of lack of efficacy:The coding conventions for lack of efficacy in the context of administration of the COVID-19 vaccine were revised on 15 February 2021, as shown below:• PT “Vaccination failure” is coded when ALL of the following criteria are met: o The subject has received the series of two doses per the dosing regimen in locallabeling. o At least 7 days have elapsed since the second dose of vaccine has been administered. o The subject experiences SARS-CoV-2 infection (confirmed laboratory tests).• PT “Drug ineffective” is coded when either of the following applies: o The infection is not confirmed as SARS-CoV-2 through laboratory tests(irrespective of the vaccination schedule). This includes scenarios where LOE isstated or implied, e.g., “the vaccine did not work”, “I got COVID-19”. o It is unknown: Whether the subject has received the series of two doses per the dosing regimen in local labeling; Howmanydayshavepassedsincethefirstdose(includingunspecified number of days like” a few days”, “some days”, etc.); If7dayshavepassedsincetheseconddose;o The subject experiences a vaccine preventable illness 14 days after receiving thefirst dose up to and through 6 days after receipt of the second dose.Note: after the immune system as had sufficient time (14 days) to respond to the vaccine, a report of COVID-19 is considered a potential lack of efficacy even if the vaccination course is not complete.Summary of the coding conventions for onset of vaccine preventable disease versus the vaccination date:
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 6. Topic
Missing Information
Description of Missing Information Description
Post Authorization Cases Evaluation (cumulative to 28 Feb 2021) Total Number of Cases in the Reporting Period (N=42086)
1st dose (day 1-13)Code only the events describing the SARS-CoV-2 infection Scenario Not considered LOELack of efficacy casesFrom day 14 post 1st dose to day 6 post 2nd dose Code “Drug ineffective”Scenario considered LOE as “Drug ineffective”Day 7 post 2nd dose Code “Vaccination failure”Scenario considered LOE as “Vaccination failure”Number of cases: 1665b (3.9 % of the total PM dataset) of which 1100 were medically confirmed and 565 non medically confirmed;Number of lack of efficacy events: 1665 [PT: Drug ineffective (1646) and Vaccination failure (19)f].Country of incidence: US (665), UK (405), Germany (181), France (85), Italy (58), Romania (47), Belgium (33), Israel (30), Poland (28), Spain (21), Austria (18), Portugal (17), Greece (15), Mexico (13), Denmark (8), Canada (7), Hungary, Sweden and United Arab Emirates (5 each), Czech Republic (4), Switzerland (3); the remaining 12 cases originated from 9 different countries.COVID-19 infection was suspected in 155 cases, confirmed in 228 cases, in 1 case it was reported that the first dose was not effective (no other information).COVID-19 infection (suspected or confirmed) outcome was reported as resolved/resolving (165), not resolved (205) or unknown (1230) at the time of the reporting; there were 65 cases where a fatal outcome was reported.Drug ineffective cases (1649)Drug ineffective event seriousness: serious (1625), non-serious (21)e;Lack of efficacy term was reported:o after the 1st dose in 788 cases o after the 2nd dose in 139 cases o in 722 cases it was unknown after which dose the lack of efficacy occurred.• Latency of lack of efficacy term reported after the first dose was known for 176 cases: o Within 9 days: 2 subjects;o Within 14 and 21 days: 154 subjects;o Within 22 and 50 days: 20 subjects; • Latency of lack of efficacy term reported after the second dose was known for 69 cases:o Within 0 and 7 days: 42 subjects; o Within 8 and 21 days: 22 subjects; o Within 23 and 36 days: 5 subjects.• Latency of lack of efficacy term reported in cases where the number of doses administered was not provided, was known in 409 cases:o Within 0 and 7 days after vaccination: 281 subjects. o Within 8 and 14 days after vaccination: 89 subjects. o Within 15 and 44 days after vaccination: 39 subjects.According to the RSI, individuals may not be fully protected until 7 days after their second dose of vaccine, therefore for the above 1649 cases where lack of efficacy was reported after the 1st dose or the
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 6. Topic
Missing Information
Description of Missing Information Description
Post Authorization Cases Evaluation (cumulative to 28 Feb 2021) Total Number of Cases in the Reporting Period (N=42086)
2nd dose, the reported events may represent signs and symptoms of intercurrent or undiagnosed COVID- 19 infection or infection in an individual who was not fully vaccinated, rather than vaccine ineffectiveness.Vaccination failure cases (16)Vaccination failure seriousness: all serious;Lack of efficacy term was reported in all cases after the 2nd dose:Latency of lack of efficacy was known for 14 cases:o Within 7 and 13 days: 8 subjects;o Within 15 and 29 days: 6 subjects. COVID-19 (10) and Asymptomatic COVID-19 (6) were the reported vaccine preventable infections thatoccurred in these 16 cases.Conclusion: No new safety signals of vaccine lack of efficacy have emerged based on a review of these cases.
a. From a total of 417 cases, 4 cases were excluded from the analysis. In 3 cases, the MAH was informed that a 33-year-old and two unspecified age pregnant female patients were scheduled to receive bnt162b2 (PT reported Off label use and Product use issue in 2 cases; Circumstance or information capable of leading to medication error in one case). One case reported the PT Morning sickness; however, pregnancy was not confirmed in this case.
b. 558 additional cases retrieved in this dataset were excluded from the analysis; upon review, 546 cases cannot be considered true lack of efficacy cases because the PT Drug ineffective was coded but the subjects developed SARS-CoV-2 infection during the early days from the first dose (days 1 – 13); the vaccine has not had sufficient time to stimulate the immune system and, consequently, the development of a vaccine preventable disease during this time is not considered a potential lack of effect of the vaccine; in 5 cases the PT Drug ineffective was removed after data lock point (DLP) because the subjects did not develop COVID- 19 infection; in 1 case, reporting Treatment failure and Transient ischaemic attack, the Lack of efficacy PT did not refer to BNT162b2 vaccine; 5 cases have been invalidated in the safety database after DLP; 1 case has been deleted from the discussion because the PTs reported Pathogen resistance and Product preparation issue were not indicative of a lack of efficacy. to be eliminated.
c. Upon review, 31 additional cases were excluded from the analysis as the data reported (e.g. clinical details, height, weight, etc.) were not consistent with paediatric subjects d. Upon review, 28 additional cases were excluded from the analysis as the data reported (e.g. clinical details, height, weight, etc.) were not consistent with paediatric subjects.
e. Different clinical outcomes may be reported for an event that occurred more than once to the same individual f. In 2 cases the PT Vaccination failure was replaced with Drug ineffective after DLP. Another case was not included in the discussion of the Vaccination failure cases because correct scheduling (21 days apart between the first and second dose) cannot be confirmed.
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
3.1.3. Review of Adverse Events of Special Interest (AESIs)
Please refer to Appendix 1 for the list of the company’s AESIs for BNT162b2.
The company’s AESI list takes into consideration the lists of AESIs from the following expert groups and regulatory authorities: Brighton Collaboration (SPEAC), ACCESS protocol, US CDC (preliminary list of AESI for VAERS surveillance), MHRA (unpublished guideline).
The AESI terms are incorporated into a TME list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.
The AESI list is comprised of MedDRA PTs, HLTs, HLGTs or MedDRA SMQs and can be changed as appropriate based on the evolving safety profile of the vaccine.
Table 7 provides a summary review of cumulative cases within AESI categories in the Pfizer safety database. This is distinct from safety signal evaluations which are conducted and included, as appropriate, in the Summary Monthly Safety Reports submitted regularly to the FDA and other Health Authorities.
Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
Anaphylactic ReactionsSearch criteria: Anaphylactic reaction SMQ (Narrow and Broad, with the algorithm applied), selecting relevant cases according to BC criteria
Please refer to the Risk ‘Anaphylaxis’ included above in Table 4.
Number of cases: 1403 (3.3% of the total PM dataset), of which 241 are medically confirmed and 1162 are non-medically confirmed;Country of incidence: UK (268), US (233), Mexico (196), Italy (141), France (128), Germany (102), Spain (46), Greece (45), Portugal (37), Sweden (20), Ireland (17), Poland (16), Israel (13), Austria, Romania and Finland (12 each), Netherlands (11), Belgium and Norway (10 each), Czech Republic (9), Hungary and Canada (8 each), Croatia and Denmark (7 each), Iceland (5); the remaining 30 cases were distributed among 13 other countries;Subjects’ gender: female (1076), male (291) and unknown (36);Subjects’ age group (n = 1346): Adultc (1078), Elderlyd (266)Childe and Adolescentf (1 each);Number of relevant events: 1441, of which 946 serious, 495non-serious; in the cases reporting relevant serious events;Reported relevant PTs: Tachycardia (1098), Arrhythmia (102),Myocardial infarction (89), Cardiac failure (80), Acute myocardial infarction (41), Cardiac failure acute (11), Cardiogenic shock and Postural orthostatic tachycardia syndrome (7 each) and Coronary artery disease (6);Relevant event onset latency (n = 1209): Range from <24 hours to 21 days, median <24 hours;
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
• Relevant event outcomeg: fatal (136), resolved/resolving (767), resolved with sequelae (21), not resolved (140) and unknown (380);Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
COVID-19 AESIsSearch criteria: Covid-19 SMQ (Narrow and Broad) OR PTs Ageusia; Anosmia
Number of cases: 3067 (7.3% of the total PM dataset), of which 1013 are medically confirmed and 2054 are non-medically confirmed;Country of incidence: US (1272), UK (609), Germany (360), France (161), Italy (94), Spain (69), Romania (62), Portugal (51), Poland (50), Mexico (43), Belgium (42), Israel (41), Sweden (30), Austria (27), Greece (24), Denmark (18), Czech Republic and Hungary (17 each), Canada (12), Ireland (11), Slovakia (9), Latvia and United Arab Emirates (6 each); the remaining 36 cases were distributed among 16 other different countries;Subjects’ gender: female (1650), male (844) and unknown (573);Subjects’ age group (n= 1880): Adult (1315), Elderly (560),Infanth and Adolescent (2 each), Child (1);Number of relevant events: 3359, of which 2585 serious, 774non-serious;Most frequently reported relevant PTs (>1 occurrence): COVID-19 (1927), SARS-CoV-2 test positive (415), Suspected COVID-19 (270), Ageusia (228), Anosmia (194), SARS-CoV-2 antibody test negative (83), Exposure to SARS-CoV-2 (62), SARS-CoV-2 antibody test positive (53), COVID-19 pneumonia (51), Asymptomatic COVID-19 (31), Coronavirus infection (13), Occupational exposure to SARS-CoV-2 (11), SARS-CoV-2 test false positive (7), Coronavirus test positive (6), SARS-CoV-2 test negative (3) SARS-CoV-2 antibody test (2);Relevant event onset latency (n = 2070): Range from <24 hours to 374 days, median 5 days;Relevant event outcome: fatal (136), not resolved (547), resolved/resolving (558), resolved with sequelae (9) and unknown (2110).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
Number of cases: 20 cases (0.05% of the total PM dataset), of which 15 are medically confirmed and 5 are non-medically confirmed;Country of incidence: UK (8), France and Poland (2 each), and the remaining 8 cases were distributed among 8 other different countries;Subjects’ gender: female (17) male and unknown (1 each);Subjects’ age group (n=19): Adult (18), Elderly (1);Number of relevant events: 20 events, 16 serious, 4 non-serious
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
Reported relevant PTs: Erythema multiforme (13) and Chillblains (7)Relevant event onset latency (n = 18): Range from <24 hours to 17 days, median 3 days;Relevant event outcome: resolved/resolving (7), not resolved (8) and unknown (6).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue.
Haematological AESIsSearch criteria: Leukopenias NEC (HLT) (Primary Path) OR Neutropenias (HLT) (Primary Path) OR PTs Immune thrombocytopenia,Thrombocytopenia OR SMQ Haemorrhage terms (excl laboratory terms
Number of cases: 932 (2.2 % of the total PM dataset), of which 524 medically confirmed and 408 non-medically confirmed;Country of incidence: UK (343), US (308), France (50), Germany (43), Italy (37), Spain (27), Mexico and Poland (13 each), Sweden (10), Israel (9), Netherlands (8), Denmark, Finland, Portugal and Ireland (7 each), Austria and Norway (6 each), Croatia (4), Greece, Belgium, Hungary and Switzerland (3 each), Cyprus, Latvia and Serbia (2 each); the remaining 9 cases originated from 9 different countries;Subjects’ gender (n=898): female (676) and male (222);Subjects’ age group (n=837): Adult (543), Elderly (293), Infant(1);Number of relevant events: 1080, of which 681 serious, 399non-serious;Most frequently reported relevant PTs (≥15 occurrences) include:Epistaxis (127), Contusion (112), Vaccination site bruising (96), Vaccination site haemorrhage (51), Petechiae (50), Haemorrhage (42), Haematochezia (34), Thrombocytopenia (33), Vaccination site haematoma (32), Conjunctival haemorrhage and Vaginal haemorrhage (29 each), Haematoma, Haemoptysis and Menorrhagia (27 each), Haematemesis (25), Eye haemorrhage (23), Rectal haemorrhage (22), Immune thrombocytopenia (20), Blood urine present (19), Haematuria, Neutropenia and Purpura (16 each) Diarrhoea haemorrhagic (15);Relevant event onset latency (n = 787): Range from <24 hours to 33 days, median = 1 day;Relevant event outcome: fatal (34), resolved/resolving (393), resolved with sequelae (17), not resolved (267) and unknown (371).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
Hepatic AESIsSearch criteria: Liver related investigations, signs and symptoms (SMQ) (Narrow and Broad) OR PT Liver injury
Number of cases: 70 cases (0.2% of the total PM dataset), of which 54 medically confirmed and 16 non-medically confirmed;Country of incidence: UK (19), US (14), France (7), Italy (5), Germany (4), Belgium, Mexico and Spain (3 each), Austria, and Iceland (2 each); the remaining 8 cases originated from 8 different countries;Subjects’ gender: female (43), male (26) and unknown (1);Subjects’ age group (n=64): Adult (37), Elderly (27);
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BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
Number of relevant events: 94, of which 53 serious, 41 non-serious;Most frequently reported relevant PTs (≥3 occurrences) include: Alanine aminotransferase increased (16), Transaminases increased and Hepatic pain (9 each), Liver function test increased (8), Aspartate aminotransferase increased and Liver function test abnormal (7 each), Gamma-glutamyltransferase increased and Hepatic enzyme increased (6 each), Blood alkaline phosphatase increased and Liver injury (5 each), Ascites, Blood bilirubin increased and Hypertransaminasaemia (3 each);Relevant event onset latency (n = 57): Range from <24 hours to 20 days, median 3 days;Relevant event outcome: fatal (5), resolved/resolving (27), resolved with sequelae (1), not resolved (14) and unknown (47).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
Number of cases: 449i (1.07% of the total PM dataset), 314 medically confirmed and 135 non-medically confirmed;Country of incidence: US (124), UK (119), Italy (40), France (27), Israel (20), Spain (18), Germany (13), Sweden (11), Ireland (9), Cyprus (8), Austria (7), Finland and Portugal (6 each), Hungary and Romania (5 each), Croatia and Mexico (4 each), Canada (3),Czech Republic, Malta, Netherlands, Norway, Poland and Puerto Rico (2 each); the remaining 8 cases originated from 8 different countries;Subjects’ gender: female (295), male (133), unknown (21);Subjects’ age group (n=411): Adult (313), Elderly (96), Infantjand Child (1 each);Number of relevant eventsk: 453, of which 399 serious, 54non-serious;Reported relevant PTs: Facial paralysis (401), Facial paresis (64);Relevant event onset latency (n = 404): Range from <24 hours to46 days, median 2 days;Relevant event outcome: resolved/resolving (184), resolved withsequelae (3), not resolved (183) and unknown (97);Overall Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue. Causality assessment will be further evaluated following availability of additional unblinded data from the clinical study C4591001, which will be unblinded for final analysis approximately mid-April 2021. Additionally, non- interventional post-authorisation safety studies, C4591011 and C4591012 are expected to capture data on a sufficiently large vaccinated population to detect an increased risk of Bell’s palsy in vaccinated individuals. The timeline for conducting these analyses will be established based on the size of the vaccinated population captured in the study data sources by the first interim reports (due 30 June
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Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb
Total Number of Cases (N=42086)
2021). Study C4591021, pending protocol endorsement by EMA, is also intended to inform this risk.
Immune-Mediated/Autoimmune AESIsSearch criteria: Immune- mediated/autoimmune disorders (SMQ) (Broad and Narrow) OR Autoimmune disorders HLGT (Primary Path) OR PTs Cytokine release syndrome; Cytokine storm; Hypersensitivity
Number of cases: 1050 (2.5 % of the total PM dataset), of which 760 medically confirmed and 290 non-medically confirmed;Country of incidence (>10 cases): UK (267), US (257), Italy (70), France and Germany (69 each), Mexico (36), Sweden (35), Spain (32), Greece (31), Israel (21), Denmark (18), Portugal (17), Austria and Czech Republic (16 each), Canada (12), Finland (10). The remaining 74 cases were from 24 different countries.Subjects’ gender (n=682): female (526), male (156).Subjects’ age group (n=944): Adult (746), Elderly (196),Adolescent (2).Number of relevant events: 1077, of which 780 serious, 297non‐serious.Most frequently reported relevant PTs (>10 occurrences):Hypersensitivity (596), Neuropathy peripheral (49), Pericarditis (32), Myocarditis (25), Dermatitis (24), Diabetes mellitus and Encephalitis (16 each), Psoriasis (14), Dermatitis Bullous (13), Autoimmune disorder and Raynaud’s phenomenon (11 each);Relevant event onset latency (n = 807): Range from <24 hours to 30 days, median <24 hours.Relevant event outcomel: resolved/resolving (517), not resolved (215), fatal (12), resolved with sequelae (22) and unknown (312).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
Number of cases: 3600 (8.5% of the total PM dataset), of which 2045 medically confirmed and 1555 non-medically confirmed;Country of incidence: UK (1406), US (1004), Italy (285), Mexico (236), Germany (72), Portugal (70), France (48), Greece and Poland (46), Latvia (33), Czech Republic (32), Israel and Spain (26), Sweden (25), Romania (24), Denmark (23), Finland and Ireland (19 each), Austria and Belgium (18 each), Canada (16), Netherlands (14), Bulgaria (12), Croatia and Serbia (9 each), Cyprus and Hungary (8 each), Norway (7), Estonia and Puerto Rico (6 each), Iceland and Lithuania (4 each); the remaining 21 cases originated from 11 different countries;Subjects’ gender (n=3471): female (2760), male (711);Subjects’ age group (n=3372): Adult (2850), Elderly (515), Child(4), Adolescent (2), Infant (1);Number of relevant events: 3640, of which 1614 serious, 2026non-serious;Reported relevant PTs: Arthralgia (3525), Arthritis (70),Rheumatoid arthritis (26), Polyarthritis (5), Polyneuropathy, Post viral fatigue syndrome, Chronic fatigue syndrome (4 each), Arthritis bacterial (1);Relevant event onset latency (n = 2968): Range from <24 hours to 32 days, median 1 day;
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Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
• Relevant event outcome: resolved/resolving (1801), not resolved (959), resolved with sequelae (49), and unknown (853).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue.
Neurological AESIs (including demyelination)Search criteria: Convulsions (SMQ) (Broad and Narrow) OR Demyelination (SMQ) (Broad and Narrow) OR PTs Ataxia; Cataplexy; Encephalopathy; Fibromyalgia; Intracranial pressure increased; Meningitis; Meningitis aseptic; Narcolepsy
Number of cases: 501 (1.2% of the total PM dataset), of which 365 medically confirmed and 136 non-medically confirmed.Country of incidence (≥9 cases): UK (157), US (68), Germany (49), Mexico (35), Italy (31), France (25), Spain (18), Poland (17), Netherlands and Israel (15 each), Sweden (9). The remaining 71 cases were from 22 different countries.Subjects’ gender (n=478): female (328), male (150).Subjects’ age group (n=478): Adult (329), Elderly (149);Number of relevant events: 542, of which 515 serious, 27non‐serious.Most frequently reported relevant PTs (˃2 occurrences) included:Seizure (204), Epilepsy (83), Generalised tonic-clonic seizure (33), Guillain-Barre syndrome (24), Fibromyalgia and Trigeminal neuralgia (17 each), Febrile convulsion, (15), Status epilepticus (12), Aura and Myelitis transverse (11 each), Multiple sclerosis relapse and Optic neuritis (10 each), Petit mal epilepsy and Tonic convulsion (9 each), Ataxia (8), Encephalopathy and Tonic clonic movements (7 each), Foaming at mouth (5), Multiple sclerosis, Narcolepsy and Partial seizures (4 each), Bad sensation, Demyelination, Meningitis, Postictal state, Seizure like phenomena and Tongue biting (3 each);Relevant event onset latency (n = 423): Range from <24 hours to 48 days, median 1 day;Relevant events outcome: fatal (16), resolved/resolving (265), resolved with sequelae (13), not resolved (89) and unknown (161);Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
Other AESIsSearch criteria: Herpes viral infections (HLT) (Primary Path) OR PTs Adverse event following immunisation; Inflammation; Manufacturing laboratory analytical testing issue; Manufacturing materials issue; Manufacturing production issue; MERS-CoV test; MERS-CoV test negative; MERS-CoV test positive; Middle East respiratory syndrome; Multiple organ dysfunction syndrome; Occupational exposure to communicable disease; Patient
Number of cases: 8152 (19.4% of the total PM dataset), of which 4977 were medically confirmed and 3175 non-medically confirmed;Country of incidence (> 20 occurrences): UK (2715), US (2421), Italy (710), Mexico (223), Portugal (210), Germany (207), France (186), Spain (183), Sweden (133), Denmark (127), Poland (120), Greece (95), Israel (79), Czech Republic (76), Romania (57), Hungary (53), Finland (52), Norway (51), Latvia (49), Austria (47), Croatia (42), Belgium (41), Canada (39), Ireland (34), Serbia (28), Iceland (25), Netherlands (22). The remaining 127 cases were from 21 different countries;Subjects’ gender (n=7829): female (5969), male (1860);Subjects’ age group (n=7479): Adult (6330), Elderly (1125),Adolescent, Child (9 each), Infant (6);
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Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
isolation; Product availability issue; Product distribution issue; Product supply issue; Pyrexia; Quarantine; SARS-CoV-1 test; SARS-CoV-1 test negative; SARS- CoV-1 test positive
Number of relevant events: 8241, of which 3674 serious, 4568 non‐serious;Most frequently reported relevant PTs (≥6 occurrences) included: Pyrexia (7666), Herpes zoster (259), Inflammation (132), Oral herpes (80), Multiple organ dysfunction syndrome (18), Herpes virus infection (17), Herpes simplex (13), Ophthalmic herpes zoster (10), Herpes ophthalmic and Herpes zoster reactivation (6 each);Relevant event onset latency (n =6836): Range from <24 hours to 61 days, median 1 day;Relevant events outcome: fatal (96), resolved/resolving (5008), resolved with sequelae (84), not resolved (1429) and unknown (1685).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
Number of cases: 69 cases (0.17% of the total PM dataset), of which 57 medically confirmed, 12 non-medically confirmed;Country of incidence: Germany (17), France and UK (13 each), US (6), Belgium, Italy and Spain (4 each), Sweden (2), Austria, Canada, Denmark, Finland, Luxembourg and Norway (1 each);Subjects’ gender: female (46), male (23);Subjects’ age group (n=68): Adult (7), Elderly (60), Infant (1);Number of relevant events: 70, all serious;Reported relevant PTs: Acute kidney injury (40) and Renal failure(30);Relevant event onset latency (n = 42): Range from <24 hours to 15days, median 4 days;Relevant event outcome: fatal (23), resolved/resolving (10), notresolved (15) and unknown (22).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue.
Respiratory AESIs
Search criteria: Lower respiratory tract infections NEC (HLT)
• Number of cases: 130 cases (0.3% of the total PM dataset), of which 107 medically confirmed;
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Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
(Primary Path) OR Respiratory failures (excl neonatal) (HLT) (Primary Path) OR Viral lower respiratory tract infections (HLT) (Primary Path) OR PTs: Acute respiratory distress syndrome; Endotracheal intubation; Hypoxia; Pulmonary haemorrhage; Respiratory disorder; Severe acute respiratory syndrome
Countries of incidence: United Kingdom (20), France (18), United States (16), Germany (14), Spain (13), Belgium and Italy (9), Denmark (8), Norway (5), Czech Republic, Iceland (3 each); the remaining 12 cases originated from 8 different countries.Subjects’ gender (n=130): female (72), male (58).Subjects’s age group (n=126): Elderly (78), Adult (47),Adolescent (1).Number of relevant events: 137, of which 126 serious, 11non-serious;Reported relevant PTs: Respiratory failure (44), Hypoxia (42),Respiratory disorder (36), Acute respiratory distress syndrome (10), Chronic respiratory syndrome (3), Severe acute respiratory syndrome (2).Relevant event onset latency (n=102): range from < 24 hours to 18 days, median 1 day;Relevant events outcome: fatal (41), Resolved/resolving (47), not recovered (18) and unknown (31).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue.
Thromboembolic EventsSearch criteria: Embolism and thrombosis (HLGT) (Primary Path), excluding PTs reviewed as Stroke AESIs, OR PTs Deep vein thrombosis; Disseminated intravascular coagulation; Embolism; Embolism venous; Pulmonary embolism
Number of cases: 151 (0.3% of the total PM dataset), of which 111 medically confirmed and 40 non-medically confirmed;Country of incidence: UK (34), US (31), France (20), Germany(15), Italy and Spain (6 each), Denmark and Sweden (5 each), Austria, Belgium and Israel (3 each), Canada, Cyprus, Netherlands and Portugal (2 each); the remaining 12 cases originated from 12 different countries;Subjects’ gender (n= 144): female (89), male (55);Subjects’ age group (n=136): Adult (66), Elderly (70);Number of relevant events: 168, of which 165 serious, 3non-serious;Most frequently reported relevant PTs (>1 occurrence) included:Pulmonary embolism (60), Thrombosis (39), Deep vein thrombosis (35), Thrombophlebitis superficial (6), Venous thrombosis limb (4), Embolism, Microembolism, Thrombophlebitis and Venous thrombosis (3 each) Blue toe syndrome (2);Relevant event onset latency (n = 124): Range from <24 hours to 28 days, median 4 days;Relevant event outcome: fatal (18), resolved/resolving (54), resolved with sequelae (6), not resolved (49) and unknown (42).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue.
StrokeSearch criteria: HLT Central nervous system haemorrhages and cerebrovascular accidents
Number of cases: 275 (0.6% of the total PM dataset), of which 180 medically confirmed and 95 non-medically confirmed;Country of incidence: UK (81), US (66), France (32), Germany(21), Norway (14), Netherlands and Spain (11 each), Sweden (9),
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Table 7.
AESIsa Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb Total Number of Cases (N=42086)
(Primary Path) OR HLT Cerebrovascular venous and sinus thrombosis (Primary Path)
Israel (6), Italy (5), Belgium (3), Denmark, Finland, Poland and Switzerland (2 each); the remaining 8 cases originated from 8 different countries;Subjects’ gender (n= 273): female (182), male (91);Subjects’ age group (n=265): Adult (59), Elderly (205), Childm(1);Number of relevant events: 300, all serious;Most frequently reported relevant PTs (>1 occurrence) included:o PTs indicative of Ischaemic stroke: Cerebrovascular accident (160), Ischaemic stroke (41), Cerebral infarction (15), Cerebral ischaemia, Cerebral thrombosis, Cerebral venous sinus thrombosis, Ischaemic cerebral infarction and Lacunal infarction (3 each) Basal ganglia stroke, Cerebellar infarction and Thrombotic stroke (2 each);o PTs indicative of Haemorrhagic stroke: Cerebral haemorrhage (26), Haemorrhagic stroke (11), Haemorrhage intracranical and Subarachnoid haemorrhage (5 each), Cerebral haematoma (4), Basal ganglia haemorrhage and Cerebellar haemorrhage (2 each);Relevant event onset latency (n = 241): Range from <24 hours to 41 days, median 2 days;Relevant event outcome: fatal and resolved/resolving (61 each), resolved with sequelae (10), not resolved (85) and unknown (83).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue.
Number of cases: 32 cases (0.08% of the total PM dataset), of which 26 medically confirmed and 6 non-medically confirmed;Country of incidence: UK (13), France (4), Portugal, US and Spain (3 each), Cyprus, Germany, Hungary, Italy and Slovakia and Costa rica (1 each);Subjects’ gender: female (26), male (6);Subjects’ age group (n=31): Adult (15), Elderly (16);Number of relevant events: 34, of which 25 serious, 9 non-serious;Reported relevant PTs: Vasculitis (14), Cutaneous vasculitis andVasculitic rash (4 each), (3), Giant cell arteritis and Peripheral ischaemia (3 each), Behcet’s syndrome and Hypersensitivity vasculitis (2 each) Palpable purpura, and Takayasu’s arteritis (1 each);Relevant event onset latency (n = 25): Range from <24 hours to 19 days, median 3 days;Relevant event outcome: fatal (1), resolved/resolving (13), not resolved (12) and unknown (8).Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue
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Table 7.
AESIsa
Category
AESIs Evaluation for BNT162b2
Post-Marketing Cases Evaluationb
Total Number of Cases (N=42086)
For the complete list of the AESIs, please refer to Appendix 5;
Please note that this corresponds to evidence from post-EUA/conditional marketing authorisation
approval data sources; c. Subjects with age ranged between 18 and 64 years;
Subjects with age equal to or above 65 years;
Subjects with age ranged between 2 and 11 years;
Subjects with age ranged between 12 and less than 18 years;
Multiple episodes of the same PT event were reported with a different clinical outcome within some
cases hence the sum of the events outcome exceeds the total number of PT events;
Subjects with age ranged between 1 (28 days) and 23 months;
Twenty-four additional cases were excluded from the analysis as they were not cases of peripheral facial
nerve palsy because they described other disorders (stroke, cerebral haemorrhage or transient ischaemic attack); 1 case was excluded from the analysis because it was invalid due to an unidentifiable reporter; j. This UK case report received from the UK MHRA described a 1-year-old subject who received the vaccine, and had left postauricular ear pain that progressed to left-sided Bell’s palsy 1 day following vaccination that had not resolved at the time of the report; k. If a case included both PT Facial paresis and PT Facial paralysis, only the PT Facial paralysis was considered in the descriptions of the events as it is most clinically important; l. Multiple episodes of the same PT event were reported with a different clinical outcome within some cases hence the sum of the events outcome exceeds the total number of PT events m. This UK case report received from the UK MHRA described a 7-year-old female subject who received the vaccine and had stroke (unknown outcome); no follow-up is possible for clarification. n. This PT not included in the AESIs/TME list was included in the review as relevant for ACCESS protocol criteria;
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3.1.4. Medication error
Cases potentially indicative of medication errors1 that cumulatively occurred are summarized below.
Number of relevant medication error cases: 20562 (4.9%) of which 1569 (3.7%) are medically confirmed.
Number of relevant events: 2792
Top 10 countries of incidence:
− US (1201), France (171), UK (138), Germany (88), Czech Republic (87), Sweden (49), Israel (45), Italy (42), Canada (35), Romania (33), Finland (21), Portugal (20), Norway (14), Puerto Rico (13), Poland (12), Austria and Spain (10 each).
Medication error case outcomes:
Fatal (7)3,
Recovered/recovering (354, of which 4 are serious),
Recovered with sequelae (8, of which 3 serious)1 MedDRA (version 23.1) Higher Level Terms: Accidental exposures to product; Product administration errors and issues; Product confusion errors and issues; Product dispensing errors and issues; Product label issues; Product monitoring errors and issues; Product preparation errors and issues; Product selection errors and issues; Product storage errors and issues in the product use system; Product transcribing errors and communication issues, OR Preferred Terms: Accidental poisoning; Circumstance or information capable of leading to device use error; Circumstance or information capable of leading to medication error; Contraindicated device used; Deprescribing error; Device use error; Dose calculation error; Drug titration error; Expired device used; Exposure via direct contact; Exposure via eye contact; Exposure via mucosa; Exposure via skin contact; Failure of child resistant product closure; Inadequate aseptic technique in use of product; Incorrect disposal of product; Intercepted medication error; Intercepted product prescribing error; Medication error; Multiple use of single-use product; Product advertising issue; Product distribution issue; Product prescribing error; Product prescribing issue; Product substitution error; Product temperature excursion issue; Product use in unapproved therapeutic environment; Radiation underdose; Underdose; Unintentional medical device removal; Unintentional use for unapproved indication; Vaccination error; Wrong device used; Wrong dosage form; Wrong dosage formulation; Wrong dose; Wrong drug; Wrong patient; Wrong product procured; Wrong product stored; Wrong rate; Wrong route; Wrong schedule; Wrong strength; Wrong technique in device usage process; Wrong technique in product usage process.2 Thirty-five (35) cases were exclude from the analysis because describing medication errors occurring in an unspecified number of individuals or describing medication errors occurring with co suspects were determined to be non-contributory.3 All the medication errors reported in these cases were assessed as non-serious occurrences with an unknown outcome; based on the available information including the causes of death, the relationship between the medication error and the death is weak. .
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Not recovered (189, of which 84 are serious),
Unknown (1498, of which 33 are serious).1371 cases reported only MEs without any associated clinical adverse event. The PTs most frequently reported (≥12 occurrences) were: Poor quality product administered (539), Product temperature excursion issue (253), Inappropriate schedule of product administration (225), Product preparation error (206), Underdose (202), Circumstance or information capable of leading to medication error (120), Product preparation issue (119), Wrong technique in product usage process (76), Incorrect route of product administration (66), Accidental overdose (33), Product administered at inappropriate site (27), Incorrect dose administered and Accidental exposure to the product (25 each), Exposure via skin contact (22), Wrong product administered (17), Incomplete course of vaccination, and Product administration error (14 each) Product administered to patient of inappropriate age (12).In 685 cases, there were co-reported AEs. The most frequently co- associated AEs (˃ 40 occurrences) were: Headache (187), Pyrexia (161), Fatigue (135), Chills (127), Pain (107), Vaccination site pain (100), Nausea (89), Myalgia (88), Pain in extremity (85) Arthralgia (68), Off label use (57), Dizziness (52), Lymphadenopathy (47), Asthenia (46) and Malaise (41). These cases are summarized in Table 8.Table 8. ME PTs by seriousness with or without harm co-association (Through 28 February 2021)
ME PTs
Accidental exposure to product
Accidental overdose Booster dose missed
Contraindicated product administered
Expired product administered
Exposure via skin contact
Inappropriate schedule of product administration
Incorrect dose administered
With Harm
0
4 0
1
0 0 0
1
Without Harm
0 0
1 9 0 0
0 0
0 0 0 0 2 8
1 0
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With Harm
Serious
Non-Serious Without Harm
5
6 1
2
2 5 264
0
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Circumstance or information capable of leading to medication error
0
0
5
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Table 8. ME PTs by seriousness with or without harm co-association (Through 28 February 2021)
Serious
Non-Serious Without Harm
ME PTs
Incorrect route of product administration
Lack of vaccination site rotation
Medication error
Poor quality product administered
Product administered at inappropriate site
Product administered to patient of inappropriate age
Overall, there were 68 cases with co-reported AEs reporting Harm and 599 cases with co- reported AEs without harm. Additionally, Intercepted medication errors was reported in 1 case (PTs Malaise, clinical outcome unknow) and Potential medication errors were reported in 17 cases.
4. DISCUSSION
Pfizer performs frequent and rigorous signal detection on BNT162b2 cases. The findings of these signal detection analyses are consistent with the known safety profile of the vaccine. This cumulative analysis to support the Biologics License Application for BNT162b2, is an integrated analysis of post-authorization safety data, from U.S. and foreign experience, focused on Important Identified Risks, Important Potential Risks, and areas of Important Missing Information identified in the Pharmacovigilance Plan, as well as adverse events of special interest and vaccine administration errors (whether or not associated with an adverse event). The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine.
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5. SUMMARY AND CONCLUSION
Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2.
Pfizer will continue routine pharmacovigilance activities on behalf of BioNTech according to the Pharmacovigilance Agreement in place, in order to assure patient safety and will inform the Agency if an evaluation of the safety data yields significant new information for BNT162b2.
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APPENDIX 1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST
The Blessed virgin promised that whatever a person asked her for during this Hour of Grace (even in impossible cases) would be granted to them, if it was in accordance with the Will of the Eternal Father
My wish is that every year on the 8 December, at noon, an “Hour of Grace” will be installed. Many spiritual graces and physical blessings will be received by those who pray, undisturbed, during this hour.
DECEMBER 8 – Feast of the Immaculate Conception – HOUR OF GRACE.
During the period of November 24, 1946 to December 8, 1947, the Blessed Mother appeared to Sister Pierina in a little church in Montichiari, Italy, eleven times. On the first appearance the Blessed Mother told Sister Pierina she wanted to be known as the “Mystical Rose” and that an Hour of Grace should be kept at noon, December 8, in all the Catholic Churches of the world. The Blessed Mother wanted this to be known through all of Italy and the entire world.
It was November 16, 1947 when Sister Pierina was finishing her thanksgiving after Holy Communion when she saw a great light. She then saw a vision of the Blessed Mother as “Mystical Rose”. Sister Pierina was so deeply moved by the stunning beauty of Our Lady that she began to talk to her. All of a sudden a gentle force made her kneel down in front of Our Lady. The Blessed Mother spoke these words, “My Son is so greatly offended by the sins of the people, especially by the sins of impurity. He is already planning to send the deluge upon the people for their destruction, but I have asked Him to show mercy and not send the destruction. So that is why I have appeared, to ask for penance and atonement for the sins of impurity.”
Again, Our Lady asked for penance. She said, “Penance is nothing more than accepting all our crosses daily willingly. No matter how small, accept them with love.” At this time she told Sister Pierina to come again December 8 at noon, “This will be my Hour of Grace.” The Sister asked how she was to prepare for this Hour of Grace. To which the Blessed Mother said, “With prayers and penance. Pray the 51st psalm with outstretched arms three times. During the Hour of Grace, many spiritual graces would be granted. The most hard-hearted sinners will be touched by the Grace of God.”
The Blessed Virgin promised that whatever a person asked her for during this Hour of Grace (even in impossible cases) would be granted to them, if it was in accordance with the Will of the Eternal Father.
It was December 7 when Sister Pierina felt the urge to go to church. This time she was accompanied by the priest and the Mother Superior. The Blessed Mother appeared with a young boy and girl dressed in beautiful white clothing. Sister Pierina was sure these little ones were angels because they were so beautiful. The Blessed Mother said, “Tomorrow I will show you My Immaculate Heart, which is so little known among the people.” She asked people to pray for Russia. “There are so many people being held prisoners of whom their families know nothing of, because they have been gone for so many years. Pray for the conversion of Russia. The suffering of the soldiers and their sacrifices and martyrdom will bring peace to Italy.” “The little children are Francisco and Jacinta. I am giving them to you as your companions. You will have much to suffer for my sake. I want simplicity and goodness from you, as of these little children.” The Blessed Mother blessed Sister Pierina, the priest and all those who were gathered there.
On the morning of December 8, people began arriving at the little church at 8:00 in the morning from neighbouring towns. By noon some 10,000 people had gathered to see the Blessed Mother, many of whom had to stand outside because the church did not have enough room for the large crowd. Sister Pierina was accompanied to church by her mother and brothers, the Mother Superior and the Chief of Police from Montichiari. Sister Pierina was reciting the Rosary with the crowd in the middle of the church. Suddenly a brilliant white light appeared from the ceiling. Stairs were coming from the light down to the floor of the church, about fifteen feet in length. The staircase was beautifully decorated with red, white and yellow roses. The Blessed Virgin appeared so radiant, dressed in white, with her hands folded. She was standing on a splendid carpet at the top of the stairs, made of the red, white and yellow roses.
In the most gentle and loving voice, Our Lady smiled and began to speak, “I am the Immaculate Conception, the Mother of All Graces and the Mother of my Beloved Son, Jesus. I want to be known as the Mystical Rose.”
“My wish is that every year on December 8th, at noon, an “Hour of Grace” will be installed. Many spiritual graces and physical blessings will be received by those who pray, undisturbed, during this hour.”
Then, slowly, she began to descend the staircase, gracefully scattering roses as she went along, until she reached midway of the staircase. Here again the Blessed Mother spoke, “I am very happy to see this great demonstration of Faith.”
Sister Pierina asked for many of the sinners to be forgiven. The Blessed Mother replied, “My Divine Son will show His Greatest Mercy as much as the people will pray for them. I want this to be known and told to the Pope (Pius XII). Tell him I want him to install the “Hour of Grace” through the whole world and even those who are not able to go to church during this hour, will receive the same graces by praying during this time in their home at noon time.” She also asked that a statue be made and placed on the spot where she stood. This should be called the “Rosa Mystica”, and carried in a procession through the town, at which time many graces will be given and cures will take place. Then the statue is to be returned to the church.
Our Lady prayed for the sick, some will be cured, others not. Many men, women and children were cured at that very instant. A 26 year old woman, who could not say a word for nine months, suddenly began shouting, “I see her, I see the Blessed Virgin.” An 18 year old girl with ulcers was instantly cured. A five year old boy who had been paralyzed was told by the Blessed Mother, “Come to me, you will be walking now.” He was on the blessed stones and was able to walk. There were three others who were very sick and were immediately cured. But of course, the greatest miracles taking place were those of the spiritual blessings being shed upon the people gathered in the church.
The Blessed Mother said, “This is the last time I will appear here. Pray, weep and do penance on these stones and you will receive the care of My Motherly Heart.” She then left the little church, but because of the unending Love of Our Heavenly Mother, she has given us “The Hour of Grace”, to be spread through the entire world. She had given all the opportunity to demonstrate our love and trust to her and to help make reparation for the grievous sins offending her Beloved Son, Our Lord Jesus Christ.
THE REQUEST OF OUR BLESSED MOTHER FOR THE HOUR OF GRACE:
1. Day and time of the Hour of Grace: December 8th, Feast of the Immaculate Conception, to be started at 12:00 noon and continuing until 1:00 p.m. for one full hour of prayer.
2. During this hour, the person making the “Hour of Grace” either at home or at Church must put away all distractions (do not answer the phones or answer any doors or do anything but totally concentrate on your union with God during this special Hour of Grace) .
3. Begin the Hour of Grace by praying 3 times the 51st Psalm with out-stretched arms. (Psalm 51 appears below)
4. The rest of the Hour of Grace may be spent in silent communication with God meditating upon the Passion of Jesus, saying the Holy Rosary, praising God in your own way, or by using favorite prayers, singing hymns, meditating upon other psalms, etc.
Remember to pray for your country during this hour. The Blessed Virgin has requested that her important message be sent throughout the entire world. Please help her Mission: that all souls be drawn to GOD and that JESUS will be loved in every heart. This is the perpetual song of her heart. Let it also be ours.
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PSALM 51
Have mercy on me, God, in your goodness; in your abundant compassion blot out my offense. Wash away all my guilt; from my sin cleanse me. For I know my offense; my sin is always before me. Against you alone have I sinned; I have done such evil in your sight That you are just in your sentence, blameless when you condemn. True, I was born guilty, a sinner, even as my mother conceived me. Still, you insist on sincerity of heart; in my inmost being teach me wisdom. Cleanse me with hyssop, that I may be pure; wash me, make me whiter than snow. Let me hear sounds of joy and gladness; let the bones you have crushed rejoice. Turn away your face from my sins; blot out all my guilt. A clean heart create for me, God; renew in me a steadfast spirit. Do not drive me from your presence, nor take from me your holy spirit. Restore my joy in your salvation; sustain in me a willing spirit. I will teach the wicked your ways, that sinners may return to you. Rescue me from death, God, my saving God, that my tongue may praise your healing power. Lord, open my lips; my mouth will proclaim your praise. For you do not desire sacrifice; a burnt offering you would not accept. My sacrifice, God, is a broken spirit; God, do not spurn a broken, humbled heart. Make Zion prosper in your good pleasure; rebuild the walls of Jerusalem. Then you will be pleased with proper sacrifice, burnt offerings and holocausts; then bullocks will be offered on your altar. Amen
Biden simple solution: force the issue with an arbitrary and low in-country force level of 2500 U.S. military personnel.
Consequences, we could not meet Biden’s demand to secure the embassy and simultaneously keep Bagram Airbase open with only 2500 combatants. Bagram closed first guaranteeing a failed evacuation.
Complex problem: securing the border.
Biden’s Simple Solution: open the border. Consequences, in 10 months the U.S. has been inundated with sick illegals, drugs, drug dealers, human traffickers, gang members, possible terrorist cells from multiple countries and now We the People are on the hook for billions of dollars to fund welfare, education, crime and medical.
Complex problem: Trump defeated every democrat and legal effort to deny building a wall on the southern border.
Biden Simple Solution: with the stroke of a pen on inauguration day, shut down construction.
Consequences, the cost to We the People is $2 billion and counting.
Complex problem: about 20-25% of the 1.7 million illegal immigrants crossing the border this year are ill, aka Covid positive.
Biden’s Simple Solution: don’t test them.Consequences, when U.S. citizens have been asked to stay home, businesses forced to shut down, schools closed, etc. the super-spreader illegals have been bussed and flown into communities all across America.
Complex problem: Americans would be horrified, ashamed and resentful of the administration if they were shown the inhumane crowded conditions of holding areas when the border patrol is overwhelmed with illegals. Biden’s Simple Solution: declare a complete blackout of media coverage of holding areas and additionally get the illegals moving on busses and planes ASAP.
Consequences, pass the problem off to communities across America without funding to support it.
Complex problem: while the southern border is processing hundreds of thousands of illegal aliens per month, the overall immigration policy for the U.S. is in desperate need of a complete overhaul.
Biden’s Simple Solution: amnesty.
Consequences, it is a slap in the face for the millions of immigrants who have worked and are working the lawful route to become U.S. citizens.
Complex problem: shipping back-log caused by long term systemic problems such as rigid union work rules, bad regulations in West Coast ports, truck restrictions, driver qualifications, unrealistic state-issued regulations, insufficient container storage areas and insufficient equipment/facilities.
Biden’s Simple solution: work weekends. Consequences, continued backlogs and empty shelves across America just in time for Christmas.
Complex problem: government-funded Covid relief packages for Americans. The $484 billion Covid Relief package made sense in April, 2020 during the economic lock-down. But not so much the $2.3 trillion in December, 2020 when economic growth factors were looking better. But it made zero sense by April, 2021 when economic recovery indicators were strong.
Biden’s Simple solution: demonstrate he was a, “President for all the people” and send out another $2 trillion in relief.
Consequences, the economic recovery hit a road-block when millions of workers were content receiving their government checks and refused to go back to work. And, there are still 10 million unfilled jobs.
Complex problem: from observing Covid-related distance learning at home, parents became increasingly aware of what is being taught and not taught in our classrooms. They openly confronted ineffective school boards across the nation.
Biden’s Simple Solution: call the outspoken parents “domestic terrorists” and weaponize the Justice Department and FBI to deal with the “problem.”
Complex problem: how to pass nonsensical liberal legislation that, if considered as a stand-alone proposal, could not survive the light of day (for example, amnesty for millions of illegal migrants).
Biden’s Simple Solution: hide hundreds of these non-passible issues in multi-trillion-dollar legislation that is thousands of pages long and unread by legislators who are asked to pass them with one up-or-down vote.
New Biden administration complex problem: how to immediately pander to the far-left liberals who voted for him.
Biden’s Simple Solution: within hours after the inauguration, alter the entire dynamic of oil production.
Consequences, immediate and continuous increasing fuel prices which negatively impact every single American.
Complex problem: how to, at least partially, pay for massive spending proposals.
Biden’s Simple Solution: equally new massive tax increases.
Consequences, general disincentivization, lack of capital for business expansion, steady slow-to-no-growth economy and taxation that will without a doubt eventually hit the middle class hard.
Complex problem: how to force the issue of transitioning to battery-powered vehicles.
Biden’s Simple Solution: implement policies that force the price of gasoline so high that battery-powered demand will go up, (maybe).
Consequences, the U.S. immediately transitioned from oil independence and exporter to dependence on OPEC imports which is an enormous geopolitical negative position.
Complex problem: how to deal with American’s displeasure at rising gas prices.
Biden’s Simple Solution: take 50 million barrels of oil out of the nation’s strategic reserve.
Consequences, 50 million barrels is equal to 2 ½ days of U.S. consumption. A 2 ½ day reprieve will have zero impact on nation-wide gas prices. The reserve is called “strategic” for a reason. Since we are now a net-importer of oil, we are subject to being cut off by suppliers. Yes, it can happen. Every one of my generation, including Biden, have vivid memories of the oil embargo in 1973-74.
Complex problem: who can supply imported oil, Venezuela, Iran, Russia?
Biden’s Simple Solution: ask OPEC to drill more.
Consequences, they said, “no.” There are potentially serious future implications in that simple answer.
Complex problem: collecting all the tax dollars owed to the federal government.
Biden’s Simple Solution: hire 86,852 additional IRS agents.
Consequences, additional $80 billion in funding. Additionally, watchdog reports say the IRS problems are widespread incompetence, mismanagement, ineptitude and abuse that will not only not be solved but exasperated by adding 86,852 new hires.
Complex problem: improving race relations.
Biden’s Simple Solution: support indoctrination of school children with Critical Race Theory which is an obvious race-divisive tool. Secondly, imply that the majority of white Americans are white supremacists, saying, “white supremacy is the most lethal threat to America today.”
Consequences, Biden rhetoric has immediately and drastically increased the racial divide in our country. Identity politics in action.
Complex problem: all categories of crime rapidly rising nationwide.
Biden’s Simple Solution: blame the racist police.
Consequences, Americans generally do not feel safe and secure.
Polling tells us these are the issues Americans worry about, “a great deal:”
ü affordable health care,
ü the economy,
ü inflation,
ü affordable energy,
ü race relations,
ü illegal immigration,
ü drugs,
ü terrorist attacks,
ü size and power of the federal government, homelessness,
ü crime and
ü Covid.
Complex problem: extemporaneously answering detailed questions concerning these type critical issues during news conferences.
Biden’s Simple Solution: address some issues with prepared teleprompter scripts.
Consequences, more often than not, he will turn his back and walk away as the media shouts questions at him. In doing so, our president is figuratively and literally turning his back on America. The combined weight of three critical character traits, accountability-trust-respect, are in play as he exits stage-left. Accountability: his remarks are routinely filled with blame; Trump, racists, white supremacists, Covid or failures of We the People. Accountability, zero. Trust: how are we expected to put our trust in someone who is frequently guilty of misrepresenting the truth about major issues? Respect: notwithstanding his decades-old obsession with being president, how can we respect someone, and his family, who knew he is physically and mentally incapable of handling the toughest leadership job in the world? How many times have we heard our president say, “I was told I am not supposed to take questions?’ Translation, I cannot be trusted to know or say the correct thing.
BOTTOM LINE:
Major national issues, immigration, the economy, entitlements, crime, education, race relations are being turned inside out by Biden-Simple-Solution, knee-jerk, vindictive decisions without a national debate and which go against the will of the American people.
Polling data:
Reputable pollsters report that:
ü 76% of American voters do not support Biden’s open borders.
ü 78% do not support more dead-end welfare entitlements without workfare incentives.
My personal “polling” says:
ü 100% of Americans are against the out-of-control rise in fuel prices.
ü 100% of Americans want better results from our broken education system.
ü 99% of Americans want sustained economic growth which cannot simultaneously exist with a Biden Simple Solution destructive tax-and-spend economic philosophy.
ü 100% of Americans do not want the IRS conducting detailed audits of their bank accounts.
ü 100% of Americans want to feel safe walking the streets of our towns and cities.
ü 99% of Americans are against dehumanizing, demonizing and defunding police.
ü 99% of Americans want criminals arrested, held, charged, prosecuted, tried and if convicted sentenced to the full extent of the law.
ü 99% of Americans want drastically improved race relations not greater division.
For an incoming president to set out, as one of his legacy accomplishments, to infuse into this country a massive policy of generational entitlement dependency through multiple, massive unaffordable programs with no workfare requirements goes against everything this great nation has been about since the first settlers arrived 500 years ago. America will always provide for those who are willing but unable to provide for themselves; but it is inhumane to infuse government dependency into the psyche of young Americans. This is not what America wants, this is not what America needs, this is an enormous stepping stone on the path to destroy our country. An entitlement nation discourages incentive to be all you can be. The Biden transformation is unconscionable leadership and one of the major stepping stones toward a socialist state.
President Biden, stop, damnit, just stop what you are doing and listen carefully to We the People. Stop telling us you, “will be president for all Americans” and start doing, not just saying, but doing what is necessary to move us forward economically, socially and culturally to be all we can and should be.
Mr. President, you have told us you want to, “transform America.” Unfortunately, you are on a very fast track to do exactly that. But when your days in the White House are over and you look back at the transformation, I do not honestly believe you will agree with the results.
There is one exception to the wisdom of the above thesis that, “For every complex problem there is a simple solution and it is usually wrong.” In this instance there is a viable simple solution; we must defeat Biden’s Build Back Broke legislation. Why?
The Penn Wharton model tells us that the most likely cost of the Build Back Better legislation is over $4 trillion dollars. There is a Simple Solution to this potentially destructive transformative bill; first defeat it then tear it completely apart and for every individual entitlement program, every major Green New Deal expenditure, every immigration, every major transformative issue, consider them as stand-alone proposals. Shine the light of day on them by letting the process play out as it should. That is, hold congressional committee hearing on each one; listening to expert witnesses. Let the media report out to We the People on each committee vote. Inform we the people so that we can respond to polls and email our legislators thereby forcing Congress to do its job.
Our Constitution, the greatest document in world history, constructed by the most brilliant assembly of men in history tells us that, “Governments are instituted among men, deriving their just powers from the consent of the governed.” Let these immortal words become the guiding light going forward for the Biden administration and our broken Congress.
Marvin L. Covault, Lt Gen US Army, retired, is the author of VISION TO EXECUTION, a book for leaders, a columnist for THE PILOT, a national award-winning local newspaper in Southern Pines, NC and the author of a blog, WeThePeopleSpeaking.com
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Dr. Robert Moynihan 
Brighton Collaboration Level BC1
391 831 1833
Number of cases: 1665b (3.9 % of the total PM dataset) of which 1100 were medically confirmed and 565 non medically confirmed;Number of lack of efficacy events: 1665 [PT: Drug ineffective (1646) and Vaccination failure (19)f].Country of incidence: US (665), UK (405), Germany (181), France (85), Italy (58), Romania (47), Belgium (33), Israel (30), Poland (28), Spain (21), Austria (18), Portugal (17), Greece (15), Mexico (13), Denmark (8), Canada (7), Hungary, Sweden and United Arab Emirates (5 each), Czech Republic (4), Switzerland (3); the remaining 12 cases originated from 9 different countries.COVID-19 infection was suspected in 155 cases, confirmed in 228 cases, in 1 case it was reported that the first dose was not effective (no other information).COVID-19 infection (suspected or confirmed) outcome was reported as resolved/resolving (165), not resolved (205) or unknown (1230) at the time of the reporting; there were 65 cases where a fatal outcome was reported.Drug ineffective cases (1649)Drug ineffective event seriousness: serious (1625), non-serious (21)e;Lack of efficacy term was reported:o after the 1st dose in 788 cases
ABYSSUS ABYSSUM INVOCAT / DEEP CALLS TO DEEP 
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