A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines ahead of the fall and winter season, according to a draft notice posted Wednesday.
The Vaccines and Related Biological Products Advisory Committee will provide recommendations on selecting the specific coronavirus variant COVID vaccine manufacturers should target with booster shots. Their advice isn’t binding, but the FDA tends to follow it.
The meeting will take place, however, as shakeups across the Department of Health and Human Services could raise new scrutiny on how boosters are developed and approved.
On Tuesday, the FDA announced the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research, which oversees vaccines as well as some genetic medicines and blood products. Prasad will be taking over Peter Marks' role, who resigned in March over differences with HHS Secretary Robert F. Kennedy Jr. on vaccines.
A critic of the FDA, Prasad has been skeptical of U.S. policies and recommendations around COVID vaccines in the past. Leerink Partners analyst Mani Foroohar wrote in a Wednesday note that Prasad’s stance significantly increases the “probability of a more restrictive COVID vaccine recommendation.”
Advisers to the Centers for Disease Control and Prevention are separately contemplating a narrower, risk-based approach to COVID vaccine recommendations, which they will vote on at a June meeting.
Already, there are signs at the FDA of a shift in the agency’s handling of COVID shots. A deadline for the FDA to approve Novavax’s protein-based shot came and went last month without action. The company later said the FDA requested a postmarketing commitment to study the shot after an approval. It’s not entirely clear what the agency has asked to do, but The Wall Street Journal reported it demanded an additional randomized controlled trial.
The FDA also appears to have shifted its approval requirements. A spokesperson for HHS confirmed to BioPharma Dive that all new vaccines must be tested in placebo-controlled trials prior to approval. In years past, updates to formulations for COVID vaccines have not been considered new products, much like how influenza shots are treated.
More recently, the FDA asked Moderna for more data on a combination flu and COVID shot it’s developing before the agency would consider an approval, delaying the expected timeline. While Moderna said its interactions with the FDA have been business as usual, Foroohar described the FDA's action as evidence of a “higher bar” for vaccines.
