FDA Panel‍ Recommends No Changes to COVID-19 boosters for fall

​ Updated May 27, 2025

The Food and Drug Administration’s vaccine advisory⁢ panel has recommended that COVID-19 ⁣vaccine manufacturers maintain the current formulation for the upcoming booster shots this fall.‍ The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 in favor of‍ keeping‌ the single JN.1 ⁢strain, which has been the ‍dominant ‍strain‍ globally as 2024, for the 2025-2026 vaccines. this decision aims to ensure timely availability of COVID-19‌ vaccines and address the ongoing need for COVID-19 boosters.

Dr. ​Eric J. Rubin, editor-in-chief of The New England Journal of Medicine, acknowledged the vaccine’s efficacy, stating, ⁣”There is efficacy. It’s not fantastic… but in a population that has broad immunity to the ⁢SARS-COV-2 virus,it wasn’t bad.”

The FDA typically follows the advice of its advisory panels. However,‍ the agency is considering requiring randomized, controlled trials for future​ COVID-19 vaccine approvals, especially for healthy ⁤individuals under⁤ 65. This‌ potential shift in regulatory approach has raised concerns among some ‍panelists.

Dr.Stanley M. Perlman, chair of microbiology and⁣ immunology at the University of Iowa, questioned whether choosing a different ⁣vaccine strain would lead ‍to regulatory delays in getting the vaccine to market.

Dr. Rubin expressed his belief that observational data from ⁢vaccine makers provides richer⁤ insights than randomized trials, given the diverse exposures to illness and vaccines within the population. “I don’t think the randomized, controlled trial is feasible,” Rubin said.

According to Dr. David C. Kaslow, director of the office of Vaccines Research and Review at the‌ FDA, the agency is‌ still discussing COVID-19 vaccine regulation. he affirmed a “shared desired ​outcome for the timely availability of vaccines to prevent ⁤COVID-19” and suggested the new regulatory framework could be a topic for a future ​VRBPAC meeting.

Representatives from pfizer, Moderna, and Novavax assured the panel that they would have vaccines ready for ⁢the fall season.

Despite the availability of vaccines, the CDC estimates that 30,000 ​to 50,000 people have died from COVID-19 since October. Vaccine ‌uptake remains low, with only about 25% of adults aged 18 to 64 and 50% of those over 75‍ choosing to get vaccinated, according to Ruth Link-Gelles of the ‍CDC.

Vaccine effectiveness ⁢against hospitalization and critical illness in⁤ adults older than 65⁣ was around 40%‌ to 50%,⁣ according to CDC data.

While⁢ vaccine makers maintain that ​their products are safe and effective, the FDA has instructed Pfizer and Moderna to update their ‌labeling to expand warnings about myocarditis and pericarditis, citing ⁤data from a Lancet study.

“Our⁤ vaccines are among the most extensively-monitored products licensed,” said Pfizer’s Modjarrad.

During the public hearing, some speakers called for the immediate‌ recall ⁣of all COVID-19 ‍vaccines, citing various harms. ​Others, like ​Dr. Kaitlin Sundling, advocated⁤ for broader access to updated​ vaccine formulations for all⁢ individuals, irrespective of age or medical history.

“All people,regardless of age and medical history,need broad access to regularly updated ⁢COVID vaccine formulations,”‍ said sundling.

What’s next

The FDA will continue to evaluate data and consider regulatory pathways for‌ COVID-19 vaccines, balancing the need for rigorous evaluation with the urgency of making vaccines available to the public.