There have been several unsubstantiated rumors that HHS Secretary Robert F Kennedy Jr (RFK) would attempt to remove COVID vaccines from the market; however, the FDA approved the Fall 2025 version of the vaccines.

RFK Jr has never been a fan of COVID vaccines, especially the mRNA-based versions. He has pushed his narrative on the COVID vaccines by overruling experts to limit the recommendations for these vaccines and ending the funding of mRNA-based vaccine research.

I’m cautiously optimistic that COVID vaccines will not be going away since the FDA, which is under the Secretary of Health and Human Services, approved new versions of them. In anticipation that the rumors about the end of COVID vaccines in the USA were true, I had investigated how I might get updated vaccines in Canada or another country. I have no interest in ending up in the hospital from COVID.

The FDA approval is good news. And we have been lacking good news from RFK Jr’s assault on vaccines.

Despite this good news, the approval did include some new restrictions on who is eligible for the vaccine. So, this post will review what the FDA approved and didn’t approve regarding the 2025 COVID vaccines.

FDA approval for 2025 COVID vaccines and the restrictions

On 27 August 2025, the FDA announced approval for updated mRNA-based COVID vaccines from Pfizer/BioNTech and Moderna, along with the non-mRNA vaccine from Novavax. The monovalent mRNA vaccines target the LP.8.1 strain of Omicron, following the advice of the agency’s vaccine advisors. 

Pfizer’s Comirnaty and Moderna’s Spikevax were approved for all adults 65 and older, but limited to people ages 5 to 64 years with at least one condition that puts them at high risk for severe COVID-19.

Moderna’s Spikevax vaccine was also approved for kids 6 months to 4 years with a high-risk condition.

Moderna’s mNexspike is approved only for individuals 12 to 64 years with a high-risk condition, and all adults 65 and up.

Novavax’s Nuvaxoid non-mRNA vaccine was approved for individuals 12 through 64 years of age with at least one underlying high-risk condition and for all adults 65 and older.

Generally, all four vaccines are approved for individuals who are 65 years of age and older, a group that is at serious risk of hospitalization and death from COVID. Spikevax is the only one currently approved for children 6 months to 4 years if they have an underlying high-risk condition.

The FDA also revoked the Emergency Use Authorizations (EUA), which were used to speed up approval of COVID vaccines (although safety and effectiveness were established before the authorization). The Pfizer vaccine EUA previously included a lower-dose shot for children ages 6 months to 4 years.

Summary

If you are 65 years old or older in 2025, you can get any of the COVID vaccines. Again, this is the most vulnerable group to the disease. This is the only good news in these approvals.

For those individuals 64 years old or younger, the vaccine is only available to individuals with comorbidities, such as diabetes, asthma, or obesity. This seems to eliminate approval for healthy individuals, such as healthcare workers, who may frequently encounter COVID patients and are at risk of contracting the disease themselves.

You may want to get the vaccine for your healthy children or yourself, ignoring the FDA approvals. Unfortunately, most (if not all) healthcare facilities will not give the vaccine to individuals who are not covered by the new vaccine approvals.

Moreover, most healthcare insurers appear to be unwilling to cover the costs of the COVID vaccines for individuals who are not covered by the CDC and FDA guidelines for the vaccine. This is beyond frustrating.

For 2025, approximately 100-1000 Americans are still dying weekly from COVID. The reason for this is mainly the low vaccination rate. With these new 2025 approvals for COVID vaccines, even fewer people are going to get the shots. Yes, the pandemic is not over.

For those of you who don’t live in the USA, you shouldn’t have to worry because your country’s public health officials don’t base their decisions on pseudoscience and vaccine conspiracies.

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