FDA panel to discuss boosters as Moderna seeks OK for additional shot

 

• Moderna on Wednesday said it had started an application to the Food and Drug Administration for clearance of a booster dose for its coronavirus vaccine; the same day the FDA announced it will convene an advisory committee in two weeks to discuss Pfizer’s submission for the same authorization.
• That meeting, which will take place on Sept. 17, comes just three days before the Biden administration said the general public can expect to start receiving booster doses. While health officials initially indicated the extra dose should be given eight months after a person’s initial inoculation, Biden recently suggested a timeline of as soon as five months.
• Earlier this week, the advisory panel for the Centers for Disease Control and Prevention briefly discussed boosters — or third doses, as the committee suggested they be called — in a daylong meeting, but they have yet to officially vote on their stance. The committee emphasized that, while boosters could be important, the U.S.’s “top priority should be continued vaccination of unvaccinated individuals.”

Moderna’s submission is a significant step toward a broader authorization for booster shots; one that Pfizer took on Aug. 25. As the delta variant spreads across the country, accounting for over 90% of new coronavirus infections, public health officials have pitched boosters as a way to maintain high protection against COVID-19. For some experts, however, the case isn’t as clear-cut when it comes to healthy adults.

The FDA expanded its authorization for the Pfizer and Moderna vaccines in August to allow some immunocompromised people to receive a third dose. The CDC’s director endorsed the expanded authorization, and the extra shot became available that same weekend. 

As of Aug. 30, nearly one million Americans had received a booster dose, according to CDC data. It’s not clear, however, who exactly is part of that group and if they were authorized to receive the additional dose.

Moderna’s booster would be a 50 microgram dose, rather than the 100 microgram dose used for the two doses currently authorized. The company suggested the third shot should be given six months after the first two doses, pointing to clinical data from 344 volunteers who received an additional shot. The third dose increased antibody levels to a higher point than after only two doses, “notably in older adults,” Moderna said.

Moderna will submit an application to the European Medicines Agency in the coming days, although the agency has said they want to see additional data before making any decisions. On Wednesday, the European Centre for Disease Prevention and Control made the same point and said there was no urgent need for booster doses yet.

https://www.biopharmadive.com/news/fda-panel-to-discuss-boosters-as-moderna-seeks-ok-for-additional-shot/606017/