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August 26, 2020 (LifeSiteNews) – The U.S. federal government launched an unprecedented effort to financially underwrite and assume the financial risk to develop a vaccine in record time against COVID-19.
The government’s “Operation Warp Speed” program has invested billions of dollars, primarily allocated through the Biomedical Advanced Research and Development Authority (BARDA), a government agency, to manufacture and distribute millions of doses of vaccines 1. BARDA is backing vaccine candidates from Janssen (a division of Johnson and Johnson), AstraZeneca, Moderna, Pfizer, Merck, Inovio and Sanofi.2 These leading vaccine candidates all share a common approach which produces a fragment of the COVID-19 virus called the “spike protein,” which by extension, would theoretically mount immunity against the entire virus3.
These vaccines were selected by BARDA because virus fragments are easy for the pharmaceutical industry to manufacture on a large-scale using readily available, off-the-shelf technologies. This would significantly reduce the time to develop a potential vaccine and allow clinical trials to be completed by the beginning of 2021 – an essential criterion conveyed to me in a direct conversation with high ranking government officials within the Department of Health and Human Services (DHHS) that are overseeing Operation Warp Speed. Additionally, one must understand that large pharmaceutical companies that received funding have well-established and influential lobbying relationships with the federal government. It is also important to note that AstraZeneca and Janssen’s vaccines use ethically controversial aborted fetal cells in the manufacturing of their vaccines 4.
The United States Conference of Catholic Bishops (USCCB) recently sent a letter urging the FDA-commissioner, Stephen Hahn, to support vaccines that are free of morally-illicit cell lines.5 Since there are five other vaccines that do not require the use of aborted fetal cells in the manufacturing process, it is comforting that there are alternative vaccine candidates that are free of moral controversy.
Since there has never been a successful vaccine produced against any infectious disease in such record time, there are real concerns whether Operation Warp Speed will deliver a safe and effective vaccine with long-term immunity that will reduce the morbidity and mortality of COVID-19 for those at greatest risk.
It is my professional opinion that these vaccines pose several scientific shortcomings that will prevent them from achieving their purported healthcare objectives. The below discussion will highlight the scientific shortcomings in a manner intended for a layperson.
First, the vaccine approaches that are currently being deployed for COVID-19 are the same approaches as those that were previously used and animal tested and evaluated in early clinical trials after the SARS outbreak in 2002 and the MERS outbreak in 2012.6 SARS and MERS carried a much higher mortality rate than COVID-19, at 10 and 30 percent respectively.7 Despite years of research, these virus fragment-based vaccine platforms failed to achieve an FDA-approved vaccine for novel coronaviruses.6
Second, Operation Warp Speed initiated clinical trials without prior testing in animal models to substantiate safety and efficacy. The FDA permitted these vaccine candidates to be directly tested into humans without first completing the necessary animal testing because of the many months to years it can take to validate safety and efficacy. Normally, anti-infectious treatments require satisfying the FDA’s two- animal rule, which requires testing any therapeutic in two animal models to validate safety and efficacy.[8]8 Prior preclinical studies showed that some animals developed a more serious pneumonia with SARS vaccines when subsequently challenged with a live SARS virus than in non-vaccinated animals.9 Thus, there is a serious concern that vaccinated patients, particularly those with co-morbidities, could develop a more serious case of pneumonia upon exposure to the virus than if they were never vaccinated in the first place.
Third, the primary outcome of these clinical trials centers on documenting humoral immunity (i.e. whether neutralizing antibody levels are elicited). Humoral immunity is generally short-lived and is not sufficient to provide long-term immunity10,11. The clinical trials are not placing equal emphasis on documenting T-cell immunity (cell-mediated immunity), which provides greater assurance for long-term immunity like what is observed for measles and mumps vaccines.10,11
A COVID-19 vaccine is unnecessary for children in whom the illness is generally mild and where the adverse risks may be higher than the benefits. In contrast, the vaccine is necessary for the elderly and immunocompromised patients – two groups that have difficulty mounting humoral and cell-mediated immunity in response to vaccines12 but whose health will be susceptible if adverse risks occur. Thus, it is quite conceivable that patients will have to receive boosters. If boosters are required, adenovirus-based vaccines, like those sponsored by Janssen and AstraZeneca, cannot be re-administered because prior exposure to the adenovirus vaccine will elicit an immune rejection against the vaccine, thereby deeming it ineffective.13
Fourth, it will be difficult to prove that these vaccines can satisfy the FDA’s criteria of efficacy, which has been defined as a 50 percent reduction in symptoms- a criteria typically reserved for influenza vaccines.14 The influenza vaccine is administered prior to the beginning of the flu season when it is feasible to quantify a reduction in influenza morbidity and mortality. However, proving clinical efficacy for COVID-19 vaccines will be very challenging because the outbreak is currently on the downslope of the incidence curve in many areas of the world, and these cases will likely further decline as the vaccines enter late staged clinical trials at the end of the year. Finding sufficient numbers of human subjects to achieve sufficient statistical confidence in a clinical trial may prove to be extremely difficult.
Many notable virologists have raised concerns that the Operation Warp Speed program is placing all of its financial resources towards vaccine approaches that lack a track record of success.15 Further, Operation Warp Speed is ignoring vaccine approaches that are based on historic tried and true approaches that rely on inactivated or killed vaccines (e.g. influenza) and live-attenuated virus vaccines (e.g. polio and small pox). Inactivated and attenuated live virus vaccines provide more long-term immunity because they elicit cell-mediated immunity by providing a greater number of viral targets to establish immunity by delivering a whole virus.16 High ranking government officials in DHHS conveyed in direct conversation that killed and attenuated live vaccines would take too long to develop and would not meet the deadlines set forth by Operation Warp Speed. However, it is disconcerting and shortsighted that little federal support is being directed towards the long-term development of traditional vaccine approaches for novel coronaviruses. If Operation Warp Speed vaccines fail to achieve safe, effective and long-term immunity, then our nation will again fail to prepare for the next pandemic from a future novel coronavirus.
Consequently, the United States needs to develop vaccines based on tried and true approaches, which can offer more definitive protection against COVID-19, particularly if the virus mutates or if there is a future novel coronavirus that poses an even higher mortality than COVID-19. Such vaccines will require more time to develop newer technologies that currently do not exist. New technologies are usually developed by small biotechnology companies, nonprofit organizations and academia. Large pharmaceutical companies are rarely the engine that creates new biotechnologies. These vaccines are critical not only to protect our economic and healthcare system and avoid a repeat of our current pandemic, but are important for our national security. If the federal government fails to act to fund such novel research approaches, this funding will have to come from the private sector and other public sources.
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1. https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html
2.https://www.pharmaceutical-technology.com/comment/operation-warp-speed-finalists-funding-initiative/
3.https://jamanetwork.com/journals/jama/fullarticle/2768155
4.https://lozierinstitute.org/an-ethics-assessment-of-covid-19-vaccine-programs/
6.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7177048/ – CR18
7.https://www.medicalnewstoday.com/articles/how-do-sars-and-mers-compare-with-covid-19
8.https://www.medicinenet.com/script/main/art.asp?articlekey=25188
9.https://pubmed.ncbi.nlm.nih.gov/18941225/
10.https://www.sciencenews.org/article/coronavirus-covid-19-vaccine-clinical-trials-speed-safety
11. .https://www.clinicaltrialsarena.com/comment/fda-covid-19-vaccines/
12. https://www.sciencedirect.com/science/article/pii/S1044532318300678
13. https://cen.acs.org/pharmaceuticals/vaccines/CanSino-publishes-first-COVID-19/98/i21
16.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2883798/
Alan Moy MD, is CEO of Cellular Engineering Technologies and Founder of the John Paul II Medical Research Institute, Coralville, IA