Ethical Science at Warp Speed
November 16, 2020
by David Prentice, PhD
COVID-19 has brought many challenges to us all—medical, ethical, societal. It has also intensified and sharpened the focus of some ongoing bioethical challenges, especially regarding fetal tissue research and the related topic of abortion-derived cell lines and vaccine production. We looked at both of these issues in the spring of 2020, early in the COVID-19 pandemic. Time for some updates, new information and analysis.
In March, we looked at the continuing controversy of fetal tissue research, especially with regard to the science and federal taxpayer funding of research with fetal tissue from ongoing abortion. Pro-abortion advocates including some scientists continue to claim that fetal tissue research saves lives and is vital to medical research, yet those claims for fetal tissue are specious and have been repeatedly proven false. The efforts to promote use of fetal tissue from induced abortion undermine research and funding that can actually help COVID-19 patients, including development of drugs as well as the potential use of adult stem cells to treat severe cases of COVID-19.
Ethical review of fetal tissue research and its funding has moved ahead as well. A peer-reviewed, comprehensive review paper on fetal tissue science, ethics and policy published in August 2020 goes into great detail on these various aspects of human fetal tissue research, debunking the claims and highlighting the numerous alternatives.
On the policy front, both the U.S. Senate and the House of Representatives called for an end to funding for human fetal tissue research, and the call to end unethical research and instead support successful, ethical science was echoed in a letter by 19 Attorneys General.
As discussed previously, the Trump administration in June 2019 stopped federal taxpayer funding of human fetal tissue research at government laboratories (“intramural research”), shifted federal funds toward development of ethical alternative research methods, and instituted an ethics review for extramural grant proposals seeking funding for further fetal tissue research. The ethics review requirement was placed into statute in 1993, but this was the first time any presidential administration invoked the ethics review. The statute spells out the procedures and makeup of the Ethics Board, including the definition: “the term ‘ethical considerations’ means considerations as to whether the nature of the research involved is such that it is unethical to conduct or support the research.” As discussed previously, nominations for the Ethics Board were solicited in February 2020. After subsequent selection of the 15 members, a meeting of the Human Fetal Tissue Research Ethics Advisory Board was scheduled for July 31, 2020.
The Human Fetal Tissue Ethics Advisory Board meeting included an open public session, welcome and charge to the board members, brief introductions of the 15 highly-credentialed professionals selected to serve, explanations of confidentiality and meeting procedures, and comments from the public. The board then went into closed session for more than five hours to discuss grant proposals requesting funds for use of human fetal tissue. Of the 14 proposals considered by the Ethics Advisory Board, only one was recommended for funding. The public report gives more details about the reviews (while maintaining confidentiality standards.) An interesting sidelight were complaints by some, including two board members, that the makeup of the panel was “stacked” against human fetal tissue research because of the supposed inclusion of numerous members opposed to abortion or fetal tissue research, and that the rejections were a foregone conclusion. Yet the actual votes shown in the public report tell a different story, with more than one-third of the proposals rejected by unanimous (15-0) or near-unanimous (14-1) votes; apparently even many of those favoring fetal tissue research could not in honesty see many of the proposals as ethical. As far as the board’s makeup, a published analysis shows that this was the first federal bioethics panel in over 40 years with a relatively balanced makeup. There are still a large number of federally-funded fetal tissue research grants, but the hope is that the movement to modern, ethical techniques will accelerate. Indications are that more scientists are moving away from use of fetal tissue from induced abortion, and that NIH is encouraging scientists to remove fetal tissue from proposals.
Vaccine development against COVID-19 also shows movement away from use of old, ethically controversial methods and cell sources to modern, ethically-sourced techniques. As we had discussed earlier in the year, the ethical consideration in this case has nothing to do with fetal tissue and ongoing abortion, but rather with the questionable ethics of using abortion-derived cell lines in vaccine production. Cells are needed for growth of viruses, since viruses are not free-living organisms, but rather must live and grow inside cells, hijacking cellular machinery for viral reproduction. Most current FDA-approved viral vaccines are made by growing the virus in cells, breaking open the cells to harvest large quantities of virus and then inactivating or weakening (“attenuating”) the virus. The whole virus is then injected as the vaccine, and our immune system reacts to this foreign object and prepares antibodies and cellular defenses against any future infection. The vast majority of cell sources for approved viral vaccines are ethically derived: various types of animal cells, insect cells, yeast, chicken eggs. But a few approved viral vaccines (nine out of 58) still are produced using one of two fetal cell lines (WI-38, MRC-5) from an abortion decades ago. Two other abortion-derived cell lines (HEK293, PER.C6) are used to make genetically-engineered adenoviruses or other viruses, or to make large quantities of protein. Cell lines are derived by growing cells in the laboratory; some cell lines have a limited life span, while other cell lines have become immortalized, capable of continuing to grow indefinitely in the lab. Fetal cell lines are in no way fetal tissue; there is a great separation both in time and in space from the original body tissue. But there remains an ethical lineage that can be traced back to the original abortion that destroyed a young human life, and that terrible origin is what causes conscience concerns among many people.
At last count, there were over 200 COVID-19 vaccine candidates; at least 39 of these are in clinical trials, though none of these have yet passed through all phases of clinical testing. So do any of the COVID-19 vaccines being developed use abortion-derived cell lines in their production? Sadly, some do, but most do not. This is due in part to several new vaccine development techniques being used. The newer techniques don’t grow whole virus for a vaccine. Instead, they use molecular techniques to create just a part of the virus, and they show that recognizable part to our immune system. (We’ve created a visual primer to show each of these techniques as well as the traditional method.) One technique makes a “viral vector,” essentially a carrier virus that transports the genetic instructions to make the viral spike protein into our cells, where the genetic information is used to make the actual protein. Another technique makes the viral protein in laboratory-grown cells, then injects the protein itself (sometimes with an adjuvant, a chemical that increases immune response) as the vaccine. Another new vaccine production technique creates mRNA in the laboratory without use of any cells, just using enzymes in a test tube; mRNA is a genetic instruction or recipe that tells how to make a protein. The mRNA recipe is encased in a lipid particle (like an oil droplet), and that is what is injected as the vaccine. The mRNA goes into our cells, and the genetic recipe is read and spike protein is made in our cells, to show to our immune system. One other new method is similar, making a DNA information molecule in the laboratory without using any cells. This genetic recipe is then given to a cell, and the information is read and used to produce the protein in our cells for our immune system.
As noted, most of the COVID-19 vaccines under development do not use an abortion-derived cell line in their development or production. This includes most of the Warp Speed candidates.[i] The rapidity of vaccine development in these cases comes not from cutting corners, but from use of the faster, modern molecular techniques for vaccine creation, as well as overlapping various parts of the normally-linear process of vaccine development, production and clinical trials. Warp Speed funding has been used to scale up production, do clinical trials and order doses of vaccines, even before knowing whether a particular vaccine will work and freeing vaccine developers to move more swiftly. All vaccines produced still must be proven safe, and they must meet a minimum effectiveness (at least 50 percent effective.)
Regarding conscience questions, knowing a vaccine’s lineage and how it is produced is essential in making an informed decision. The possibility for conscience concerns by potential vaccine recipients also creates ethical demands on policymakers, healthcare officials, scientists, vaccine creators and funders, whether or not they themselves have an ethical concern. Access to a safe, effective vaccine by the entire citizenry is a public health issue. This is why it is important to advocate for vaccines produced using ethical methods. We should also advocate for new, ethically-sourced cells and methods used in quality-control tests of vaccines. Production method directly affects the vaccine recipient, it determines what is injected, and ethical production lines are important in conscience considerations. Testing methods bear on the ethical choices of the scientists, and we should consider their consciences as well.
We have produced a chart, updated as possible, that gives background information on a number of the COVID-19 vaccines, including any use of abortion-derived cell lines, to help people make informed choices.
[i] The chart found here on the Charlotte Lozier Institute website details additional COVID vaccine candidates, including Operation Warp Speed candidates that used fetal cells from the HEK-293T cell line to perform a confirmatory lab test.