Last May, the FDA announced it would require randomized clinical trials demonstrating benefit in lower-risk populations before granting COVID-19 vaccine approvals beyond adults 65 and older and those with at least 1 risk factor. The American Academy of Pediatrics called it dangerous. The Infectious Diseases Society of America urged doctors to keep vaccinating off-label. And I read the actual regulatory standard the FDA cited and thought: yes, that is how drug approval is supposed to work.
The FDA's restriction is scientifically defensible. It is, in fact, the evidentiary bar the agency applies to virtually every other pharmaceutical product on the market. We do not approve statins for healthy 25-year-olds without trial data showing benefit in that group. We do not approve antihypertensives for people with normal blood pressure on the theory that it probably won't hurt. The COVID vaccine got broad authorization under emergency conditions that no longer exist. Asking for evidence of benefit in low-risk groups before formal approval is not radical. It is the baseline.
Emergency Logic Has an Expiration Date
The emergency use framework made sense in 2020. SARS-CoV-2 was a novel pathogen. Population-level immunity was zero. Hospitalization rates across all age groups justified broad deployment before the full trial picture was complete. That was a defensible asymmetry: the known risk of the virus outweighed the unknown risk of the vaccine for nearly everyone.
That asymmetry has collapsed. By early 2026, most Americans have been infected multiple times, vaccinated multiple times, or both. The virus circulates as a seasonal respiratory pathogen. For a healthy 30-year-old with hybrid immunity, the marginal benefit of an updated booster is not zero, but it is not established either. And "not established" matters. The FDA's job is not to assume benefit. Its job is to confirm it.
AAP President Susan Kressly warned in August 2025 that "any barrier to COVID-19 vaccination creates a dangerous vulnerability for children." I take pediatric infectious disease seriously. Amesh Adalja's point that children under 2 with no underlying conditions still face elevated hospitalization risk is legitimate and worth studying. But legitimate concern is not a substitute for trial data. The plural of "clinical worry" is not "evidence."
Access Is Not Approval
The loudest criticism conflates 2 distinct things. The FDA restricted formal approval. It did not ban the vaccines. The October 2025 ACIP recommendation preserved shared clinical decision-making for anyone 6 months and older. HHS Secretary Kennedy himself stated the vaccines remain "available for all patients who choose them after consulting with their doctors." Off-label prescribing is legal, common, and how roughly 20% of all outpatient prescriptions work in the United States (Radley et al., Archives of Internal Medicine, 2006, n=160 million prescriptions).
Granted, the practical effect of removing broad approval will reduce uptake, especially among people without a regular doctor or with insurance uncertainty. That is a fair concern. But the solution to an access problem is better access infrastructure, not lower approval standards. You do not fix a distribution failure by pretending the evidence says something it does not.
I should be honest about a tension in my own position. The political context makes this harder to defend. Vinay Prasad, who oversaw CBER and helped implement these restrictions, resigned March 11 effective end of April. The court blocked RFK Jr.'s childhood vaccine schedule overhaul on March 17 because the reconstituted ACIP lacked meaningful expertise; a judge noted only about 6 of 15 members had relevant backgrounds. The leaked PACVS proposal relied on a Rasmussen poll and case reports. The administration's credibility on vaccine science is, to put it gently, poor.
But a bad messenger does not make the message wrong. The evidentiary standard the FDA articulated last May would have been correct under any administration. It would have been correct if the most pro-vaccine HHS secretary in history had announced it. Requiring proof of benefit before approval is not anti-vaccine. It is pro-evidence. The two should be the same thing, and it is a failure of our politics that they no longer sound like it.
If the trials show clear benefit for healthy adults, approve the vaccines broadly. If they do not, the restriction stands. That is the process working as designed, for the first time in 6 years.
