New post on Children of God for Life COVID-19 Vaccine & HEK293: Testing and Production are Ethically Equalby Stacy TrasancosThe phrase “confirmatory testing” has been invoked as the basis for the ethical consideration of the three lead COVID-19 vaccines, Moderna, Pfizer, and AstraZeneca. Moderna and Pfizer are considered more morally permissible because their connection to abortion is very remote since they only used an aborted fetal cell line in something called “a confirmatory test.” AstraZeneca, in contrast, grows the vaccine in fetal cell lines in an ongoing way, and moral theologians say it should be avoided in favor of Moderna or Pfizer.This critical phrase, “confirmatory test,” is due for an examination. I will argue that testing and production are ethically equal if the testing is ongoing. The purpose of this argument is to put aside the COVID-19 ethical debates and unite as one voice to call for an end to the use of aborted children in research.Point 1: “Remote cooperation in evil” is not a new term.To quickly review the ethics, the moral liceity of using vaccines produced in fetal cell lines is not a new judgment. The Pontifical Academy for Life in 2005, and three years later in 2008 the Congregation for the Doctrine of the Faith in its “Instruction Dignitas Personae on Certain Bioethical Questions,” provided guidelines for Catholics on the permissibility of receiving vaccines whose origins are connected with cells coming from an aborted child. Such vaccines were deemed morally illicit, but their use is morally licit in certain situations because the patient’s use is only “remote cooperation in evil.” It is not, after all, the fault of the patient that researchers, industries, and government provide no alternative.Permission for using unethically produced vaccines comes with obligations, however. Use is only licit if:1) the need to protect individuals and populations is grave,
2) there is no alternative,
3) we continue to reject the evil of abortion and the use of aborted children in research.Parents and doctors have been operating under these guidelines for several decades. At both an individual and a social level, it is difficult to, on one hand, accept the vaccines while, on the other hand, reject them.At the individual level, the faithful must exercise prudential judgment. Just like the Church does not dictate whom to marry or how many children to raise, the Church provides moral guidance on vaccines. We all must make our own decision. To do that about vaccines, we need good scientific information too. At a social level, it is undeniably harder to make the case against abortion and the use of aborted children in research when moral theologians have made it known that benefiting from these practices can be morally licit.Point 2: Moral assessment depends on accurate information.To navigate the morality of novel situations in challenging times, accurate information is necessary. A review the science seems warranted, especially since so much information has been circulating and we now have some benefit of hindsight.Traditional attenuated virus vaccines are grown in cells. Much like a seed needs soil to grow, the weakened form of the viruses for vaccines need a medium to grow. Vaccines that are grown in HEK293, or any other abortion-derived cells, are morally illicit. HEK293 cells are a cell line derived from a healthy aborted child in the 1970s. The cells were cultured by scientist Alex Van der Eb and Frank Graham in their lab at the University of Leiden, Holland. The name HEK stands for “human embryonic kidney,” the 293rd experiment. It is worth noting that these were not early embryos as we use the word today but what we now identify as fetuses. The aborted child had to be old enough for the adrenal organs to have developed.The Moderna and Pfizer vaccines are new kinds of vaccines called mRNA vaccines. These are not grown in cells but synthesized as molecules. The mRNA is coated in a nanolipid and injected into the body where it synthesizes (expresses) the spike protein (an antigen). The immune system responds with antibodies. The spike protein is the part of the coronavirus that interacts with the body’s cells, so if the immune system builds up antibodies to the spike antigen, we are protected against the whole COVID-19 virus.On August 5, 2020, the pre-clinical trials for the Moderna vaccine were published in the journal Nature, “SARS-CoV-2 mRNA vaccine design enabled by prototype pathogen preparedness.” The team of researchers described testing protocols. According to the methods section, the in vitro mRNA expression lab tests were done by transiently transfecting (introducing) HEK293 cells with mRNA that encodes for the spike protein. They did this test to see if the mRNA would make the spike protein in the cells like it is supposed to do in the body. The team also tested the vaccine on mice and demonstrated that it induced antibodies against COVID-19 infection.Likewise, on September 8, 2020, Pfizer’s team published their pre-clinical trials, “A prefusion SARS-CoV-2 spike RNA vaccine is highly immunogenic and prevents lung infection in non-human primates.” They also reported results from in vitro mRNA expression lab tests. The mRNA molecule was incubated in HEK293 cells followed by structural characterization of the expressed protein. Tests in rhesus macaques and mice were also successful.Both Moderna and Pfizer, then, claim to use HEK293 in in vitro lab testing for their vaccines.Point 3: Focus on “confirmatory testing” derailed the ethics.The in vitro testing was ignored for the most part. Back in May of 2020, the Charlotte Lozier Institute had claimed that both the Moderna and the Pfizer vaccines are “ethically uncontroversial” because they do not use fetal cell lines. An mRNA vaccine is not grown in cells like traditional vaccines are, so it seemed at the time, perhaps, that the ethical issue had been avoided.At the end of September, nearly two months after the Moderna report and one month after the Pfizer (mentioned above), Charlotte Lozier updated their summary to say that Moderna and Pfizer use the HEK293 fetal cell line in research and something called “confirmatory testing.” This term was not, at that time, defined in terms of exactly what the researchers were doing in the laboratory.Unfortunately the term was interpreted by Catholic scientists, bioethicists, and theologians as a one-time test, which was taken to mean that the connection to abortion was doubly or triply remote because not only did the vaccine not touch the cells, it was not produced in the fetal cell line in an ongoing way.By mid-November as the phase III trials were completed on thousands of people, the message spread rapidly that the Moderna and Pfizer vaccine pose no ethical issues, again, without any specific definition of the meaning of “confirmatory test.” Meanwhile Moderna’s stock went from $67 per share on October 30 to $170 by December 8, 2020.To be clear, it is not apparent whether there is any causation to this correlation, but this much is a fact of history now. The bioethicists, moral theologians, and clergy did not question the meaning of this phrase “confirmatory testing” as the message spread widely that these vaccines are ethically uncontroversial.It began as reports of successful phase III trials for Moderna were published on November 16. Wesley J. Smith of the Discovery Institute wrote at National Review that “Moderna COVID Vaccine Did Not Use Fetal Cells,” citing the pro-life Charlotte Lozier Institute.On November 17, Dr. John Brehany, director of institutional relations at the National Catholic Bioethics Center (NCBC), was quoted by the Catholic News Agency in “The ethics of Moderna’s coronavirus vaccine” as saying that while Moderna has some association with the use of cell lines from elective abortions, “its vaccine was not produced using HEK293 cells.”On November 18, Zelda Caldwell wrote at Aleteia that “Both Moderna and Pfizer’s coronavirus vaccines were made without fetal cells,” again citing the Charlotte Lozier Institute. The author stated, “Unlike some other vaccines in development, both vaccines were made without the use of fetal cells, or for that matter, any cells at all.”On November 22, Public Discourse, the journal of the Witherspoon Institute founded by Ryan Anderson, published an article by Fr. Matthew Schneider, “Vaccines and Doubly Remote Cooperation in Evil,” claiming that “both the Pfizer and Moderna vaccines seem to pose no significant moral concern.” Fr. Schneider cited the Charlotte Lozier Institute stating that the difference between production and testing provides another level of remoteness. If HEK293 is used in testing, he reasoned, it is not morally problematic because “a test is done once and is already completed by the time you get vaccinated.”Many more authors commented from there, too many to list.The NCBC published a statement on December 8 titled “Points to Consider on the Use of COVID-19 Vaccines.” The language was repeated, saying that these two vaccines “do not use abortion derived cell lines in the manufacturing process but did use them at one point in development, such as for confirmatory testing.” NCBC said they are “preferable to those that utilize abortion-derived cell lines in more than one phase of development and, in particular, in the manufacturing process.”This message spread throughout the United States and even to the Vatican. Crux reported: “The Pontifical Academy for Life and Catholic bishops around the world, including the chairmen of the U.S. bishops’ doctrine and pro-life committees, have said it is not immoral to be vaccinated with vaccines like the Pfizer/BioNTech product because any connection they have to aborted fetuses is extremely remote. Such cells derived from those fetuses were used only in a testing phase but not in the production phase.”On December 11, the United States Conference of Catholic Bishops (USCCB) released a statement, “Moral Considerations Regarding the New COVID-19 Vaccines,” echoing the idea that some pharmaceutical companies are “making use of a morally compromised cell line only for a confirmatory test of the vaccine’s efficacy.”The language was repeated in diocese after diocese after diocese (etcetera) as encouragement to use the Moderna or Pfizer instead of other vaccines grown in fetal cell lines spread. The bishops found the AstraZeneca vaccine to be “more morally compromised” and consequently concluded that this vaccine “should be avoided” if there are alternatives available.At a time when Catholics should have been united with one voice demanding that the market provide ethically produced vaccines, we instead missed the moment to effectively protest.Point 4: Ongoing quality control testing is the determining factor.So, what kind of testing is done during production? That is the critical question relevant to the moral assessment. The answer is: we do not know, but we can look in the scientific reports linked above for an idea. The in vitro lab tests described in both Moderna’s and Pfizer’s pre-clinical trial reports were not ever claimed to be a one-time confirmatory test, not even by the companies themselves. No one used that language except the Charlotte Lozier Institute and those who referenced them.Typically, in research and development, scientists use pure knowledge gained from the scientific method (research) and apply it to solve problems. Once a potential product has been identified, work to bring the product to market (development) begins. If that is successful, the goal is then to figure out how to scale up the lab synthesis to a manufacturing facility, the same way a cook scales up a recipe to feed a crowd. Small problems are magnified when you go from feeding four to feeding four hundred, and they need their own solutions.For the mRNA vaccines, it only makes sense that the in vitro lab test (described above) would also become an essential part of the production process for ensuring the vaccine is produced as it was designed in the laboratory, especially a development that was as rushed as the COVID-19 vaccines to distribute globally. In manufacturing, this production testing is commonly known as quality control (QC) testing. Even bottling water requires strict quality control testing.Therefore, when an R&D project is scaled up to production, it is standard practice to migrate the same lab tests from research and development to quality control. That is, simply, how the scientists and engineers know they are making the same product as designed in the lab. Quality control testing is not separate from, or ancillary to, production; to repeat, it is essential to production, a mature applied science unto itself, existential to manufacturing. Imagine the consequences if a pharmaceutical company started producing vaccines without ongoing testing!The Centers for Disease Control (CDC) explains how a new vaccine is developed and approved for manufacturing. Moderna’s and Pfizer’s pre-clinical trials follow the plan. Vaccine development is done in the laboratory before tests are done on animals and then humans.The Food and Drug Administration (FDA) also must approve manufacturing to make sure they comply with the “Current Good Manufacturing Practice” regulations. The FDA regulates the quality of pharmaceuticals very carefully because batches of medicines must meet quality standards to ensure safety and effectiveness. Quality control testing is key. The new vaccines for COVID-19 are being rushed to production under an emergency approval process, so we do not know what the licensed manufacturing plan will be.Since the HEK293 cell line is used in the in vitro lab test, it stands to reason that it is part of the production process to ensure the mRNA is synthesized and performs as expected. Some bioethicists have argued that the remoteness lies in the fact that the vaccine injected into the body does not contain fetal cells or touch fetal cells, but this is irrelevant to the ethical question. The determining criteria is whether the aborted fetal cell line is used in ongoing production.Hence: Quality control testing and production are ethically equal.To summarize, if the in vitro lab test is part of the production manufacturing protocol, and it almost certainly is, then the Moderna and Pfizer vaccines are no different ethically than the AstraZeneca vaccine or any other vaccine grown in fetal cell lines. In both cases, the production of the vaccine depends on the ongoing use of the illicit fetal cell line. To accept the vaccine means accepting the continued use of cells originating from an aborted child. Given the horrifying way aborted children are still being butchered for scientific research, we cannot be complacent.So: Stick with zero-tolerance of abortion.It is troubling that the moral assessment of the COVID-19 vaccines depended on the use of an ambiguous term. Such vagueness renders individual prudential judgement impossible. More so, it has cost us in the effort for social change toward the sanctity of life.How will Catholics effectively protest the use of aborted children in research when industry, university, and government officials know that Church leaders will deem it morally licit for the 77 million US Catholics to benefit from such research without much of a critical assessment? There is a solution though.When I was a homeschooling mom, we had a saying among us about evil. We used it when our kids wanted to argue that a little wrong should be okay. “It’s like poop in brownies,” we saliently said. “If I baked you a pan of brownies and told you that I accidently got some of the baby’s poop in the mix while stirring the batter, would you eat a brownie from the pan?”Obviously, no. It does not matter if there is the tiniest smudge of poop, or if there is one or two bigger chunks, nobody is having it. In the professional realm, we call this “zero-tolerance.” A company that has a zero-tolerance policy for sexual abuse, for example, is not going to engage in a debate about whether one case of employee abuse is acceptable while two or three would cross a line. None of it is acceptable.To bring this idea into the COVID-19 vaccine and aborted fetal cell line debate, I propose that the pro-life community get back zero-tolerance of the evil of abortion. We should stop arguing about whether testing is better than production and specifically demand that all testing and production be ethically performed. And then we should focus our energy on demanding an end to the use of aborted children in research and an end to abortion absolutely. As the Pontifical Academy for Life and the Congregation for the Doctrine of the Faith instruct, that should have been the guiding principle all along.Stacy Trasancos is executive director of St. Philip Institute, chief research officer of Children of God for Life. She was senior research chemist at DuPont, has a PhD in chemistry, MA in dogmatic theology, and seven children.Stacy Trasancos | January 7, 2021 at 5:28 pm | URL:

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I am a retired Roman Catholic Bishop, Bishop Emeritus of Corpus Christi, Texas
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