Published June 28, 2022
Am I the only one who finds it curious that, while baying about how “safe and effective” COVID-19 vaccines are for children, FDA employees are still working from home?
Recently, the Vaccine and Related Biologics Advisory Committee (VRBPAC) meeting voted (nearly) unanimously to give emergency use authorization for COVID-19 vaccines for children as young as 6 months old. America is now the only country on the planet that allows mRNA injections for kids under 5 years old.
After watching hours and hours of the discussion that was uploaded online, I noticed a curious thing. Seemingly all FDA employees had called into the meeting from what looked like their homes. While I could understand the need to allow advisory committee meeting members, who are volunteers from anywhere in the country, to call in from their homes, there is no excuse for FDA employees to continue working from home.
With a 96.5% vaccination rate across the federal government, including 96.4% within HHS, it is safe to assume that the majority of FDA employees are vaccinated and boosted. After all, it’s the same vaccine that their own FDA approved. At the same time that the White House continues to parrot that the vaccines are “safe and effective” for kids and infants, it would be strange for vaccinated and boosted FDA employees to work from home based on concerns about COVID.
If there is hesitancy regarding the COVID-19 vaccine efficacy among FDA employees, then why on earth, and to this very day, is the FDA’s homepage actively picturing and pushing for everyone else to get the vaccine?
Let me say again: On both June 14th and again on June 15th, the advisory committees just voted (nearly) unanimously on all approvals for children as young as six months old. But they’re working from home….
First, let’s address the “safe” part on “safe and effective.”
More than 12 billion doses of COVID-19 vaccines have been administered worldwide with more than 830,000 COVID-19 vaccine-related adverse events reported. This number, according to a recent Harvard University study, is estimated to represent only approximately 1% of the actual number of COVID-19 vaccine adverse events. At this point, most Americans know someone who died or had a serious adverse event due to COVID vaccination.
Surely the FDA would have updated the vaccine label by now to reflect these risks, right? Wrong!! As a drug safety expert, it boggles my mind why the FDA remains as silent as the grave on COVID-19 vaccine mortality and morbidity. But maybe Pfizer’s, Moderna’s, and the FDA’s logic is more pedestrian.
For those confused about the FDA’s silence, the following image will explain the FDA’s logic in assessing Pfizer and Moderna COVID vaccine safety:
(Image courtesy of David Gortler.)
Addressing “efficacy” next, it is a problem that is even more obvious to Americans. For example, in June 2022, Anthony “The Science” Fauci, who had received four doses of the COVID-19 vaccine and was the national poster boy for mask-wearing, still tested positive for COVID.
Despite claims of “mild disease if vaccinated,” the data shows it’s not just “boostered” people who have mild, non-life threatening COVID-19 symptoms— it’s almost everyone, regardless of their booster/vaccination status, according to Johns Hopkins University.
The lack of efficacy can easily be explained by the fact that all COVID vaccines, including the newest Novavax vaccine granted an EUC in early June 2022, are for the original (i.e., 2019) version of COVID and that there is no “2022” vaccine to accommodate all the new mutations. Even though the “flu” vaccine is reformulated every year, the FDA is still pushing the same tired 2022 version of the COVID vaccine.
If the COVID-19 vaccines really were safe and effective, you would think the FDA employees would have already returned to work, setting an example for employees all over the country.
The American public deserves transparency. They deserve the facts before they vaccinate their children. And they deserve to know why, if the vaccine is so safe and effective, FDA employees are still working from home.
David Gortler, Pharm.D. FCCP is a Fellow at the Ethics and Public Policy Center whose work focuses on FDA oversight and accountability. Dr. Gortler is a pharmacologist and pharmacist and a Yale-trained bench research scientist in molecular biology with a subspecialty in the field of vascular medicine. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Center for Bioethics, and was an FDA Medical Officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner.