FDA approves COVID-19 vaccines only for 'high risk' people

The Food and Drug Administration (FDA) on Wednesday approved the updated version of Pfizer's and Moderna's COVID-19 vaccines for this upcoming respiratory viral season, but limited the approval to seniors and people at a high risk of severe infections, reducing the eligibility pool.

Moderna announced the FDA approved its updated Spikevax vaccine, which will target the LP.8.1 variant of SARS-CoV-2.

"The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older," the company said in a press release.

Pfizer's updated vaccine, called Comirnaty, was approved for adults 65 and older as well as people between 5 and 64 years with at least one underlying condition that puts them at risk of severe outcomes from the virus.

Describing the updated shot, Pfizer said in a statement, "The application also included data from pre-clinical models showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and other contemporary sublineages, compared to the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines."

This represents a smaller cohort of patients to last year when previously vaccinated people 6 months and older were eligible for at least one dose of either Moderna or Pfizer's updated COVID-19 shots.

Since assuming office, Health and Human Services Secretary Robert F. Kennedy Jr. has moved to limit the vaccines to only high-risk people, announcing earlier this year the Centers for Disease Control and Prevention (CDC) would no longer recommend COVID-19 vaccinations for children without underlying conditions or pregnant women.

He reiterated this belief on Wednesday when he announced the FDA was rescinding the emergency use authorizations for COVID-19 vaccines.

“FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+)," Kennedy wrote on social platform X. "These vaccines are available for all patients who choose them after consulting with their doctors."