The FDA Shouldn’t Cut Corners on Child Vax Safety

Published October 29, 2021

National Review Online

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 Rubin, an advisory-committee member to the FDA, said this during an official FDA hearing about the COVID vaccine in children five to eleven: “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. Rubin, that isn’t “the way it goes.” American children deserve better than that.

Despite the admitted lack of safety data, the FDA “expert” advisory committee went on to vote 17–0 for emergency-use authorization of the vaccine. This is a scandal.

The FDA’s medical mission is fundamentally 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 vaccine mandates, we depend more than ever on the FDA’s remaining independent and scientifically objective and on its advisory committee’s 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 the composition of FDA advisory panels themselves. In order to serve as an outside expert at the FDA, one 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. But 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 being 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 comprehensively address safety concerns will only undermine its goal of mass vaccination of kids and their anti-vaccine or vaccine-hesitant parents. 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).

The FDA’s mandated drug-safety testing requirements have been around since 1938. Before that, the only requirement as of 1899 was that what was in the bottle had to be accurately reflected on the container’s list of ingredients. It wasn’t until 1962 that the FDA mandate of a beneficial effect or efficacy was added.

A central question that seems to have been ignored by the FDA is whether emergency vaccination of children five to eleven years old is needed at all, given the well-established low risk of serious COVID complications in children, especially with the dominant variant and the availability of therapeutics with known safety records, mask-wearing, and social distancing as alternate protective measures.

As is already known, the FDA still hasn’t gotten around to releasing its medical-officer report detailing the FDA’s comprehensive findings on safety from its August 23 approval of the Pfizer vaccine. Despite that, this FDA advisory committee is comfortable recommending that parents administer that same biotechnological to America’s children without knowing about its safety? It breaks all FDA norms and practices to leap into this so blindly, especially when we are talking about children.

Emergency approval for young children is not the same as the emergency approval of COVID vaccines for adults in 2020. We are no longer deeply embedded in the throes of the pandemic. It’s unclear why we now need emergency measures in the form of FDA EUAs for such young children, except, conceivably, in the most vulnerable children.

Leaving the bioethics argument and question of using our children as test subjects aside: Whatever happened to “following the science”? What about the physician’s centuries-old sacrosanct vow of doing no harm?

As someone who has committed the past two decades of his life to drug epidemiology and drug safety, and served as adviser to the former FDA commissioner on the same, I rely on the FDA’s objective historical standard of drugs needing to be comprehensively tested for safety before recommending them.

The FDA’s lack of drug-safety transparency is disappointing, as is the FDA panel’s abandonment of basic safety standards that have served us well for nearly a century.

With Biden’s FDA and “experts” like these, it sounds as if safety simply isn’t a priority.

David Gortler is a pharmacologist, a pharmacist, and an FDA and health-care policy scholar at the Ethics and Public Policy Center in Washington, D.C.

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