How Should Individuals Interpret the FDA’s Latest COVID-19 Vaccine Authorization?

This week, the FDA authorized updated COVID-19 vaccines for fall 2025, limiting eligibility to adults aged ≥65 years and individuals with at least one underlying medical condition that increases risk of severe illness.¹

However, in a confusing announcement posted on social media site, X, Health and Human Services Secretary Robert F. Kennedy Jr. said the vaccines are still for everyone. “The marketing authorization for those at higher risk include Moderna (6+ months), Pfizer (5+), and Novavax (12+).These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy wrote.²

Although the vaccines may be available after consulting providers,
The new restrictions may affect insurance coverage for those outside the designated high-risk groups. According to CDC’s vaccine price list, a COVID-19 dose without insurance may cost up to $140.¹

“I am pleased that we have 25-26 COVID-19 vaccines, FDA licensed, but I and my colleagues at NFID are dismayed to say the least about the restrictions placed on the vaccine,” Robert H Hopkins, Jr, MD, medical director of the NFID said. “You know, we still have evidence that we see hospitalizations, we see severe disease, we see death in people that don't have risk factors. And I think limiting the vaccine access to only people who have risk factors, and at age 65 and older, is going to place lives at risk.”

This decision comes a few months after the leaders of the National Institutes of Health, the US Department of Health and Human Services (HHS), and the FDA announced the removal of the COVID-19 vaccine from the Centers for Disease Control and Prevention (CDC) immunization schedule for pregnant women and healthy children.³ Days later, the federal government changed its stance on the vaccine and healthy children. On the CDC's Child and Adolescent Immunization Schedule by Age, the COVID-19 vaccines are available to the pediatric population under what is called shared clinical decision-making in the guidance.

One thing is clear the leadership in public health are doing what they can to confuse and dissuade people from getting vaccines, whether by minimizing the eligible groups or providing doubts about their efficacy.

“It appears to me that there is a, shall we say, a preference among some of those individuals to limit or to reduce access to COVID-19 vaccines, [there] appears to be some bias against those vaccines and their effects, and I don't think that's in accordance with the science,” Hopkins said.

He notes he was working in the clinic today and people were asking about the vaccines.

“A move by this in itself can reduce confidence in vaccines and confidence in the COVID-19 vaccine itself. I saw a number of adult patients, and at least two of them raised the concern about, ‘Does this mean the vaccine is not beneficial and is not safe in people that are not high risk and not over 65?’ And that took extra time out of my morning to explain to them that this is a regulatory change that was made that is not in accord with the evidence, as I've seen it,” Hopkins said. “I think reducing confidence in effective vaccines that have saved millions of lives is not in the good service of the American people.”

References
1. Contagion Editorial team. FDA Approves Updated COVID-19 Vaccines for Fall 2025, Restricts Eligibility to High-Risk Groups. August 29, 2025. Accessed August 29, 2025.
https://www.contagionlive.com/view/fda-approves-updated-covid-19-vaccines-for-fall-2025-restricts-eligibility-to-high-risk-groups
2.X post. August 27, 2025. Accessed August 29, 2025.
https://x.com/SecKennedy/status/1960742897201872969
3. Parkinson J. Federal government changes course again on COVID-19 vaccine policy. Contagion. June 2, 2025. Accessed July 11, 2025.
https://www.contagionlive.com/view/federal-government-changes-course-again-on-covid-19-vaccine-policy