Published April 11, 2022
On January 24, 2022, The FDA revoked Emergency Use Authorizations (EUAs) for two COVID monoclonal antibody (McAb) treatments, bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), made by Eli Lilly and Regeneron respectively.
Again on March 25, the FDA revoked the EUA for sotrovimab, which is no longer authorized for use at this time in specified states and territories due to its ineffectiveness against the prevalence of Omicron sub-variants, such as BA.2 in those regions, brought in from overseas. Even these state-of-the-art McAbs can’t keep up with the rapidly mutating, highly transmissible COVID-19 variants.
In doing so, the FDA is admitting that these expensive treatments, do not work against Omicron and chose to pull the plug in the face of incontestable evidence. An adjustment to scientific reality is normally welcome, but in this case, it appears to heighten the FDA’s hypocrisy in obstinately pushing the COVID vaccines as “the only solution.”
McAbs are highly-specific treatments that work by targeting the various “spike proteins” on the COVID-19 virus. These spike proteins are the “keys” that COVID and all other viruses use to penetrate human cells and proliferate and cause illness. McAbs target and occupy those keys in a highly specific manner to mitigate disease progression. However, with COVID’s spike proteins having mutated, as all SARS-CoV-2 type viruses do over time, existing McAbs are stated to be no longer effective. Sequencing data has shown that the primary Omicron variant contains 30 mutations in its encoding spike proteins.
In withdrawing authorization for COVID McAb treatments, Patrizia Cavazzoni, the new director of the FDA’s Center for Drug Evaluation and Research under Biden, stated that the treatments “are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States.” According to the Centers for Disease Control and Prevention, Omicron is responsible for more than 99 percent of cases in the United States.
Yet FDA officials are still pushing a potentially unsafe and seemingly ineffective vaccine. Just look at today’s screenshot of the FDA website advocating for boosters in children and young people (way under that age of 49), despite the latest CDC data saying that there is no benefit in those groups:
If monoclonal antibody EUAs are being revoked, shouldn’t COVID vaccine approvals be as well?
The COVID vaccines currently on the market work in a similar fashion in that they were designed to address the spike protein profile of the original COVID-19 strain, which has almost completely disappeared and been taken over by numerous mutations. It only takes one mutated spike protein to potentially render a vaccine ineffective, so it is no surprise that the vaccines are not effective in stopping Omicron’s spread.
From a basic biology/virology standpoint, a study out of Columbia University examined the original virus and compared it to the Omicron variant. It warned that Omicron’s “extensive” spike protein mutations “raise the specter that current vaccines and therapeutic antibodies would be greatly compromised.” The study goes on to state: “We found [Omicron] to be markedly resistant to neutralization by serum not only from convalescent patients, but also from individuals vaccinated with one of the four widely used COVID-19 vaccines.” [Emphasis added]
Remember what happened when Anthony Fauci and Pfizer preached 100% vaccine efficacy about a year ago, which kept dropping before our eyes as overseas mutations came into the USA through our porous, wide-open borders? Plus: What about vaccine safety, which Fauci never seems to specifically address as he forever carries on about how effective vaccines are? Now: New vaccines being proposed by Sanofi and GlaxoSmithKline are being developed, claiming 100% efficacy.
If the vaccines were innocuous and completely safe, that would be one thing, but there have been hundreds of thousands of reported adverse events in the USA alone, and there is a strong indication that that number only represents 1 to 13 percent of the actual number of safety events.
If old monoclonal antibodies don’t work, neither will old vaccines/ booster shots
Administering currently available vaccines and boosters for Omicron are akin to giving last year’s flu vaccine for next year’s flu, because the flu virus regularly mutates. And now, the FDA has finally admitted that its approved COVID McAbs no longer work and is pulling them off the market. Yet the White House, Fauci, and the FDA stubbornly cling to their narrative, even granting full approval to Moderna’s vaccine just one month ago, despite the longstanding, clear graphical data detailing how titanically ineffective it is at stopping the spread on a purely epidemiological basis.
Omicron sprinted through the currently available vaccine and boosters so successfully that it is practically guaranteed that anyone reading this article knows a vaccinated person who got sick with COVID this winter —or you yourself got it—despite all the lockdowns, vax passports, vax mandates, double-masking, fourth boosters, social distancing, et cetera, that Biden and Fauci repeatedly promised would protect and keep Americans safe.
Amending a famous quote from Groucho Marx, we have a choice: Do we believe the White House or do we believe our own eyes?
The FDA is aware of this fact, and at least one pharmaceutical company has already developed and received FDA authorization for bebtelovimab, a newly designed McAb made specifically to combat the latest COVID-19 mutation. Isn’t it true that, for the same reason we need new McAbs, we would also need new vaccines for Omicron? Why is the FDA suspiciously wedded to its failed strategy against Omicron?
President Trump was able to get us a vaccine for the original strain in record time despite Biden’s casting doubt on the safety of Operation Warp Speed while he was a candidate. But now that he is sitting in the Oval Office, Biden’s strategy has been to rely on the rapidly diminishing returns of Trump’s effort and doubling down through mandates and demonization of those who disagree through mainstream news and media.
Loud disagreements at the FDA under Trump … conspicuous silence under Biden
This is just one more in what is becoming an embarrassingly long history of the FDA and the federal government testing a hypothesis, examining the data, and then deliberately ignoring the findings in service to a political narrative. The additional silence by career FDA PhD scientists, physicians, pharmacists, and administrators at America’s supposedly nonpartisan independent public health agencies about decisions that have been made, which have been — to put it diplomatically — seriously questionable, makes one wonder how dedicated to public health any of those taxpayer-funded workers really are. It is noteworthy that those exact same employees had no problem repeatedly expressing their concerns under Trump when they were troubled about decisions lacking scientific merit.
If the old monoclonal antibodies aren’t working because COVID has mutated, then by extension, wouldn’t the original mRNA vaccines also be ineffective? Didn’t the FDA’s nixing of EUAs for monoclonal antibodies just prove that?
It’s time for this the FDA and Fauci to explain their logic, or explain where this interpretation and assessment of the scientific and epidemiologic literature is at fault. Otherwise, it seems to those of us giving attention to this matter that yesterday’s vaccine is not the answer to today’s COVID problem, or tomorrow’s.
Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and health policy fellow at the Ethics and Public Policy Center. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethics Center, and was an FDA medical officer who was later appointed by the White House as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs. He is a columnist at Forbes, where he writes on drug safety, health care, and FDA policy.