by James Lyons-Weiler, PhD, Popular Rationalism, ©2025
(Jul. 13, 2025) — Washington, D.C. — July 2025. According to CBS News, members of the US Health and Human Services administration “overrode career staff at the agency to limit the approvals of COVID-19 shots from Novavax and Moderna”. On May 16, 2025, the U.S. Food and Drug Administration issued a 19-page Decisional Memorandum that rewrites the standing framework for COVID-19 vaccine authorization. The verdict: COVID-19 vaccines should not be recommended for the general, low-risk population. The FDA concluded that for healthy individuals under age 65 without comorbidities, “the available data do not provide a basis for concluding that the benefits of the vaccine outweigh its risks.”
This determination, outlined in a licensing memo for Novavax’s Nuvaxovid vaccine, was not disclosed in a press conference or fact sheet. Instead, it appeared under the heading of a traditional Biologics License Application (BLA)—a bureaucratic vessel carrying a regulatory bombshell.
From Universal to Targeted: A Reversal of Regulatory Posture
Under the prior administration, the FDA promoted universal vaccination against COVID-19, including mandates and repeated boosting in healthy children and adults. Now, under Health and Human Services Secretary Robert F. Kennedy Jr., the agency has turned sharply. The license for Novavax’s vaccine was limited to adults 65 and older and individuals aged 12–64 who have at least one comorbidity known to increase COVID-19 severity.
Dr. Vinay Prasad, who replaced Peter Marks as FDA’s chief scientific officer, overrode the recommendation of career FDA reviewers. Prasad’s memo cites multiple factors, including reduced severity of circulating strains, high seroprevalence from prior infection, underpowered safety data, and methodological flaws in vaccine effectiveness studies. He warned that even rare adverse effects could now outweigh benefits in healthy individuals.
“The decrease in the chance of developing severe COVID-19, means that the potential for absolute benefit from vaccination has simultaneously decreased. Even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits in non-high-risk populations.” — Dr. Vinay Prasad, FDA Override Memo, May 2025
This is how regulation should be done: Based on evidence, not consensus opinion.
FDA: Immunobridging is Not Enough
Novavax’s application relied on immunobridging data—lab-based measures of antibody production—instead of fresh clinical trial evidence of protection against severe outcomes. The FDA called this insufficient for the general population.
Surrogate endpoints, the agency now concedes, cannot substitute for evidence of real-world benefit. The once-assumed correlation between neutralizing antibodies and reduced mortality or hospitalization remains unproven.
Career Staff Recommended for All — Against Evidence
Documents obtained by CBS News confirm that the FDA’s internal review team supported full licensure for individuals aged 12 and up. Career scientists argued that the available safety and immunogenicity data met statutory requirements.
But Prasad and his special assistant Dr. Tracy Beth Hoeg disagreed. Their position: the post-pandemic landscape no longer justifies broad authorization. The override memo further stated that new post-market RCTs should be required before any future expansion of the vaccine label.
Safety Signals: Myocarditis, Neurological, Thrombotic Risks
The memo highlights unresolved safety signals, including:
- Myocarditis in young males
- Neurological adverse events
- Thromboembolic complications
Though causality was not declared, the FDA noted that Novavax’s safety data was underpowered to rule out serious harm, especially in populations unlikely to benefit.
Bias and Observational Artifacts
The FDA also flagged healthy vaccinee bias as a source of inflated benefit claims. Observational studies used to justify ongoing vaccination campaigns were confounded by differences in baseline health status.
Prasad noted that future vaccine approval frameworks would require randomized controlled trials stratified by age, comorbidity, and prior infection history—standards not met by prior COVID-19 vaccine approvals.
A Kennedy Administration Correction
Critics, including former FDA officials, have complained that Kennedy’s appointees are sidelining career civil servants. But supporters argue that Prasad, Makary, and Hoeg are reinstating rigorous scientific review. An HHS spokesperson rejected the accusation of politicization, stating: “Dr. Prasad is correcting course with data, with transparency, and with the courage to say what others won’t. That’s how trust in science is rebuilt.”
Under the new framework, no COVID-19 vaccine will receive general-use approval without showing statistically significant reductions in severe disease in randomized trials—not just improvements in antibody titers.
The Kennedy Bar: Evidence Over Institutional Inertia
The memo represents a formal shift to what we now call “The Kennedy Bar”—an evidentiary threshold that prioritizes actual health outcomes over institutional allegiance. Under this standard:
- Immunobridging is insufficient
- Observational data must be corrected for bias
- Real-world benefit must exceed known and unknown risks
Conclusion: An Ongoing Reckoning
FDA’s narrow approval of Novavax is a tacit admission that blanket COVID-19 vaccination of healthy people was unsupported by the evidentiary standard that now governs agency decisions. This shift, enforced against the advice of careerists, is not political—it is empirical. Will the approval continue long-term? Who knows; It’s up to the COVID-19 vaccine manufacturers to produce the post-market pharmacovigilance data showing both safety and efficacy under the watchful eye of a vaccine-risk aware HHS administration.
It’s their job to be watchful and aware. Anything less would be regulatory malpractice.