Before parents consent to vaccinate their children against COVID, basic medical ethics requires that they be informed of how safe the vaccine is. Yet in a shocking on-video admission, Dr. Eric Ruben, an advisory committee member to the FDA, said this about the COVID vaccine in children five to eleven during an official FDA hearing: “We’re never going to learn about how safe the vaccine is until we start giving it. That’s just the way it goes.”
No, Dr. Ruben, that isn’t “the way it goes.” American children are not experimental subjects. You could and should have demanded more safety studies.
Despite the admitted lack of safety data, the FDA “expert” advisory committee went on to vote 17–0 for emergency-use authorization of the Pfizer-BioNTech COVID-19 vaccine. The FDA itself codified their recommendation on Friday. This is a scandal.
The FDA’s fundamental medical mission is a simple one. Its job is to make sure that our drugs, biologics, and medical devices are free of impurities; that they are safe; and that they have a positive clinical benefit. Given that the FDA is a public- health agency, and especially given the White House’s appetite for vaccine mandates, we depend more than ever on the FDA remaining independent and scientifically objective and on its advisory committee strictly adhering to its clinical and scientific responsibilities. Under the still commissioner-less Biden FDA, they aren’t, and this isn’t the only example.
One of the problems is how the FDA advisory panels are composed. To serve as an outside expert at the FDA, the person selected cannot have even the appearance of an outside conflict of interest. Those conflicts obviously include having been employed by a pharmaceutical company whose drugs are under review.
Also excluded are scientists who have ever received funding from any pharmaceutical company in the form of research grants or speaking fees. Since “publish or perish” research is a core component of academic tenure, and research is very expensive, scientists may find themselves in a position of needing funding from private sources at some point, including “Big Pharma.”
Moreover, prohibitions on speaking fees preclude most top experts from FDA advisory committees because they are precisely the ones most in demand for talks at conferences. Consequently, the people serving on FDA committees are sometimes not the most well-informed individuals when it comes to knowing or even understanding the complex fundamentals of FDA regulatory affairs or the FDA’s mission.
As a former FDA medical officer/senior medical analyst on the FDA’s Division of Metabolism and Endocrinology, I recall that my FDA colleagues and I were more than a little puzzled to hear FDA advisory members asking elementary questions already answered at length during advisory committee meetings. It made us realize that they didn’t fully understand the material placed before them.
Dr. Rubin’s comment during Tuesday’s official FDA panel makes me realize that, despite his Harvard and New England Journal of Medicine chief-editor pedigree and acumen, he does not understand the FDA’s fundamental safety mission. Neither does the rest of the advisory committee, which may have just followed Dr. Rubin’s lead because of his auspicious titles.
The fact remains that America’s young children are not drug-safety research volunteers, and the panel’s failure to address comprehensively safety concerns will only undermine its goal of mass vaccination of kids and getting their anti-vaccine or vaccine-hesitant parents vaccinated too. Because the Biden administration is fond of using the FDA as cover for its medical mandates, it is all the more important that the FDA produce comprehensive and conclusive safety data for public review before approving the vaccines—even if it’s for emergency-use authorization (EUA).