FDA Narrows COVID-19 Vaccine Approvals to Those at High Risk

The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines from Pfizer and Moderna for the upcoming respiratory virus season, but limited eligibility to seniors and people at heightened risk of severe illness, marking a shift from broader recommendations in previous years, The Hill reported.

The FDA cleared Moderna’s updated Spikevax shot for adults 65 and older, as well as individuals 6 months through 64 with at least one underlying condition linked to serious COVID-19 outcomes.

Pfizer’s Comirnaty vaccine received approval for the same senior group and for those ages 5 to 64 with qualifying health conditions.

Pfizer noted that preclinical data show its LP.8.1-adapted vaccine produces stronger immune responses against multiple circulating subvariants, including XFG and NB.1.8.1, compared with earlier formulations.

"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," the company said.

The move reduces the pool of Americans eligible for vaccination compared with last year, when nearly all individuals 6 months and older could receive updated shots.

Health and Human Services Secretary Robert F. Kennedy Jr., who has emphasized scaling back COVID-19 vaccination to high-risk groups, has overseen the policy shift.

Earlier this year, he announced that the Centers for Disease Control and Prevention would no longer recommend the vaccines for children without underlying conditions or for pregnant women.

Kennedy highlighted the FDA’s new stance in a statement on Wednesday, noting that the agency rescinded emergency use authorizations for earlier vaccines.

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

Meanwhile, the new COVID-19 variant XFG has become the dominant strain in the U.S. as infections continue to rise across the country.

For the week ended Aug. 16, 9.9% of the 32,998 Americans tested were positive for COVID-19, according to the latest data from the CDC. That marked a 1.4 percentage point increase from the previous week.

During the same period, 0.4% of cases led to death, unchanged from the week before, while 1.2% resulted in an emergency room visit — up 0.2 percentage points.