The chief vaccine regulator wants to make immunizations scarcer in the name of safety.
Medical innovation has been imperiled by the heavy hand of HHS under Robert F. Kennedy Jr., whose tendency toward intrusive government has trickled throughout the department. It is his job, RFK Jr. believes, to allow patients to access only those drugs and treatments that he endorses. This paternalistic regulatory philosophy of eliminating risk at all costs has infected the highest ranks of the Food and Drug Administration, a small but powerful node within the HHS behemoth.
RFK’s protégé in the FDA is Vinay Prasad, director of the Center for Biologics Evaluation and Research, which reviews and regulates biologic drugs and — most critically — vaccines. After Prasad was pressured out of the agency by the White House this summer, Kennedy pleaded successfully for his reinstatement two weeks later.
Thanks to his boss, Prasad is free to overhaul how the FDA reviews new and updated vaccines for approval. His preferences are not a mystery. Prasad wrote in 2023, “I am a progressive. I favor a strong regulatory state (please read my books and you will see!), and I support Bernie Sanders.” Of course, he has found a home in a Republican administration as functionally progressive as he is.
As head of the Center for Biologics Evaluation and Research, Prasad effectively controls which vaccines Americans are able to receive. No vaccine can be prescribed or administered without the FDA’s sign-off, and every new or updated immunization requires approval. This regulatory authority is why, as columnist Allysia Finley wrote for the Wall Street Journal, “Dr. Prasad wields more power than Anthony Fauci ever did at the National Institutes of Health.”
He seems to be using that power to crack down on vaccines. News outlets reported Friday that Prasad had circulated a memo to FDA staff describing his plan to tighten regulations around vaccine approval, justifying the move by claiming — without evidence or citation — that the Covid vaccine was linked to the death of ten children.
The implicit argument here is that America and the world would have been better off had the Covid vaccine’s release been delayed. Had the FDA batted around the formulation for a few more months in 2021, perhaps it could have averted the deaths of those ten unnamed children (a very questionable figure). But, as the great economist Thomas Sowell likes to ask, “At what cost?” The answer is millions of lives.
According to the WSJ, Prasad wants to reshape the vaccine review process in ways that would satisfy Elizabeth Warren:
The changes outlined by Prasad are likely to reshape how vaccines are developed in the U.S. and have major impacts on vaccine makers. The FDA will “revise the annual flu vaccine framework,” Prasad said, calling the current approach a “catastrophe of low-quality evidence.” The agency will also require companies to submit larger studies about the effects of giving several immunizations at one time.
The agency will also require vaccine makers to conduct larger clinical trials before they are approved in broad populations, Prasad said, rather than relying on tests of immune responses to allow vaccines to be given to more groups such as children and pregnant women.
Prasad said the agency would no longer rely on certain study results to approve vaccines for pregnant women, saying “prior promises will be null and void.”
The cumulative effect of these changes, if realized, would be a far more difficult path for developers to get any new vaccine approved by the FDA. Even annual updates, such as for flu shots, would be subject to strict scrutiny. Companies would need to spend much more time and money to get their vaccines to market, and the uncertainty surrounding their approval would be significantly higher.
Prasad’s plan would change the vaccine landscape in two big ways — both of which would harm the large majority of Americans who appreciate vaccination. Most immediately, it would mean vaccines take months or years longer to become approved as developers labor to meet the FDA’s new requirements. The large clinical trials that Prasad is demanding take a lot of time and resources to complete. While the FDA double-checks whether a vaccine is perfectly safe, Americans will enjoy all the safety of no vaccine.
In the long run, Prasad’s proposals would undoubtedly deter the development of new vaccines in the first place. Vaccine makers are rational economic actors like any other business, comparing the costs of current investments to projected future revenues. Prasad would squeeze them on both ends, raising the already-enormous cost of developing a vaccine with more and larger trials while also delaying vaccines’ approval dates, thereby limiting the period of patent exclusivity when companies can recoup their R&D costs. As pharmaceutical price controls under the Inflation Reduction Act have proven, worsening the economic incentives for drugmakers results in fewer drugs being made.
When Americans can’t access a vaccine to protect them from the next awful disease, Vinay Prasad will say he is keeping them safe. The physicians and patients who must deal with the consequences may disagree.