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 individuals at a high risk of severe infections, reducing the eligibility pool.
Moderna announced that the FDA had 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 individuals aged between 5 and 64 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 individuals six months of age and older were eligible for at least one dose of either Moderna of Pfizer’s updated COVID-19 shots.
Since assuming office, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has moved to limit the vaccines to only high-risk individuals, announcing earlier this year that the Centers for Disease Control and Prevention (CDC) would no longer be recommending 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.”
