When Science is Sidelined: A Call to Action on COVID-19 Vaccine Access

New FDA policy proposals threaten to restrict millions of people's access to updated COVID-19 vaccines. Here's what that means—and why we must speak up (click here for details).

Below are. my comments, verbatim, as they were shared today with the FDA find my comment below, which was shared with the FDA.

”I am writing to express my deep concern regarding the recent announcement by FDA leadership—Drs. Vinay Prasad and Marty Makary propose that updated COVID-19 vaccines be limited to individuals aged 65 and older or those with at least one chronic health condition, and new placebo-controlled trials for younger populations are required before approval.

This proposed policy significantly departs from long-established regulatory practices rooted in evidence-based medicine and public health principles. COVID-19 vaccines have undergone extensive clinical evaluation and post-market surveillance globally, with overwhelming data confirming their safety and effectiveness across age groups. The FDA’s own emergency use and full approvals in prior years were based on rigorous real-world and trial data reviews.

Restricting access to updated vaccines for healthy individuals under 65—especially children—without compelling new scientific evidence of harm or ineffectiveness undermines public trust in regulatory institutions and endangers public health. It places an unprecedented burden of proof on vaccine developers, essentially penalizing innovation and responsiveness in a rapidly evolving viral landscape.

The insistence on new placebo-controlled trials with long timelines, while viruses continue to mutate and spread, is ethically questionable and scientifically unnecessary, given the wealth of existing immunogenicity and effectiveness data. This policy risks creating delays in protection, leaving millions more vulnerable and contributing to the erosion of herd immunity.

This precedent also opens the door to broader restrictions on vaccines under similar pretexts, threatening access to lifesaving immunizations across the board. Coupled with a rise in misinformation, anti-science rhetoric, and recent surges in preventable diseases such as measles, this FDA policy shift could have devastating long-term consequences for public health in the United States.

I urge the FDA to reconsider this policy and uphold its mandate to protect the health of all Americans—guided not by ideology but by science, safety, and equity.”


Take action today and submit your comment to FDA today in this link: https://www.safecommunitiescoalition.org/vaccine-access?emci=599db6e7-ce37-f011-a5f1-6045bda9d96b&emdi=349cdd1f-da37-f011-a5f1-6045bda9d96b&ceid=39429