FDA Approves 3 New COVID-19 Vaccines

The U.S. Food and Drug Administration has granted approval to updated COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Sanofi, targeting the XFG subvariant of the JN.1 lineage. The approval, announced on August 27, covers individuals aged 65 and older as well as those aged 12 to 64 with underlying health conditions such as obesity that increase the risk of severe COVID-19 outcomes. The new vaccines use either mRNA technology (Pfizer and Moderna) or a protein-based approach (Sanofi).

According to the Centers for Disease Control and Prevention, earlier versions of COVID-19 vaccines provided approximately 58% protection against hospitalization. Regulators have been updating vaccine formulations annually to better match circulating virus strains. Unlike prior approvals, the FDA did not issue a formal press release for this decision. Both the FDA and the Department of Health and Human Services declined to comment when contacted.

Health and Human Services Secretary Robert F. Kennedy Jr. has previously expressed skepticism about mRNA vaccines for respiratory illnesses, arguing they offer limited effectiveness. FDA documents indicate that manufacturers will conduct single-arm human studies rather than placebo-controlled trials due to operational challenges. This decision comes despite earlier FDA statements emphasizing the need for new placebo-controlled trials to assess vaccine performance, as such studies have not been conducted in years. Pfizer, Moderna, and Novavax—which has licensed its vaccine to Sanofi—have committed to eventually running placebo-controlled trials.

Approval for the updated vaccines was largely based on non-human data, including animal studies presented during a spring advisory meeting. The FDA’s Vaccines and Related Biological Products Advisory Committee subsequently recommended targeting the XFG subvariant for the next round of vaccines. Recent data shows a significant decline in vaccine uptake, with only 17.5% of adults and 10% of children receiving a dose in late 2025 or early 2026, according to CDC figures. The agency also reported that COVID-19 infections are rising or likely rising in 47 states based on modeling estimates released this month.

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