Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Out with the old and in with the new: Monday, the U.S. FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna, simultaneously bidding adieu to the companies’ bivalent shots in the U.S.

The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. Specifically, each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.1.5, according to the companies and the FDA.

Meanwhile, Novavax’s revised shot is still pending regulatory approval.

Moderna noted the COVID is “on the rise again” and warned of a “’tripledemic’” of COVID, flu and respiratory syncytial virus this winter and fall. Vaccines should remain “top of mind," the company said.

Following the FDA nods, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Tuesday to discuss recommendations on the updated shots.

The FDA based its approvals on evaluations of manufacturing data in support of the 2023-24 season shift. The agency also examined preclinical immune response data on the updated formulations.

Moderna says it will begin shipping doses to vaccination sites across the U.S. quickly. It's expecting the vaccines to arrive in the “coming days.”

Pfizer and its German partner BioNTech have been manufacturing doses ahead of time to ensure supply readiness as well.