Before Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. took office, he promised, “We’re not going to take vaccines away from anybody.” Since then, consumers have seen ever-increasing vaccine restrictions, from prescription requirements to confusing legal standards for providers. Now, it seems like things will get even worse for those patients who desire more access to vaccines. The Food and Drug Administration (FDA) — a subagency of HHS — is using unproven claims of vaccine-related deaths to push for new restrictions and delays on approving these products. Secretary Kennedy should back away from destructive new regulations and reaffirm his promise to protect patient choice.
The HHS and FDA are determined to deny vaccine access to millions of Americans. In a Nov. 28 memo sent out to agency staff, FDA Center for Biologics Evaluation and Research Director Vinay Prasad claimed that “no fewer than 10” of 96 child deaths reported to the Vaccine Adverse Event Reporting System (VAERS) from 2021 to 2024 were “related” to COVID vaccination.
However, instead of presenting any plausible evidence that the deaths were caused by vaccination, Prasad claimed that “likely/probable/possible attribution made by staff” informed the FDA’s finding. The FDA could have simply noted the association and made that clear without speculating needlessly over causation. Prasad used the (weak) finding as an occasion for grandstanding, stating, “The US FDA will acknowledge that COVID-19 vaccines have killed American children.” The FDA’s actions are tantamount to finding that midazolam — a drug commonly used in end-of-life care to decrease restlessness and anxiety among patients — is correlated with higher mortality and should therefore face greater agency scrutiny. Technically true, but unconvincing.
Proposed new regulations on vaccines are bad news for patients. According to Prasad, the FDA will “demand pre-market randomized trials assessing clinical endpoints for most new products.” In particular, the FDA “will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints.” As health care scholars and doctors have repeatedly pointed out, mandating that vaccine producers undergo additional clinical trials whenever they want to bolster their products with additional viral or bacterial strains would delay updates by several years.
According to Jake Scott, a clinical associate professor of infectious disease and geographic medicine at Stanford University School of Medicine, conducting annual large clinical trials on influenza vaccines before the start of every flu season would be effectively impossible because of these vaccines’ six-month production cycles. It’s also completely unnecessary because new iterations of the vaccines are made the same way. It is the viral strains that change from year to year to keep the vaccines up to date. Additionally, requiring randomized trials for pregnant women would impose additional costs and high hurdles because pregnant women are traditionally excluded from these trials.
It would be bad enough if the FDA were only increasing restrictions on vaccines. Unfortunately, the HHS subagency’s push for new regulations is impacting ordinary medicines as well. Drug approvals are down compared to previous quarters, and the agency is taking longer to evaluate marketing applications. Meanwhile, drug developers report inexplicable rejections from the FDA even after their products appear to be on track for approval.
In many cases, the rejected drugs have already been approved in other developed nations. The FDA has repeatedly refused to greenlight an ophthalmic version of the already-approved Avastin for wet age-related macular degeneration. The agency (wrongly) claims that there isn’t enough evidence that the medication works, a contention that even notoriously risk-averse European regulators reject. But what’s good enough for German and United Kingdom patients apparently isn’t good enough for their transatlantic cousins.
The HHS and FDA should reverse course and commit to protecting patient choice. Secretary Kennedy can save and improve countless lives just by keeping his word.
Ross Marchand is a senior fellow for the Taxpayers Protection Alliance.
