Confusion persists after US FDA approves new COVID-19 vaccines

The US Food and Drug Administration (FDA) has green-lit updated COVID-19 vaccines for the 2025–26 season for select groups, but confusion is already mounting over how physicians and insurers will handle the shots.Unlike in previous years, when boosters were broadly recommended for everyone over 6 months old, this year’s formulations are approved for people 65 years old and older and those with underlying health conditions, which have historically included asthma, cancer, and chronic kidney disease, among others. The new labels are in line with an updated framework that FDA commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) director Vinay Prasad outlined in May.Moderna’s COVID-19 vaccine Spikevax is approved for people 6 months through 64 years of age with at least one underlying condition and all adults 65 and older. The company’s newer formulation, mNEXSPIKE, has similar parameters but is not approved for those 11 years old and under; the same goes for Novavax’s shot. Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty, is approved for 5- to 64-year-olds with at least one underlying condition and all adults 65 and up. The FDA revoked its emergency use authorization for children under 5 for Comirnaty, leaving Moderna the only manufacturer with a shot for young kids. Moderna says it expects its updated vaccines to be available in the US “in the coming days.”But who will be able to get these vaccines, and at what price, is a different question. The US Centers for Disease Control and Prevention (CDC) has yet to