FDA to Approve Updated COVID Vaccines Soon

The FDA is expected to approve updated COVID-19 vaccines from Moderna and Pfizer/BioNTech targeting the KP.2 strain soon, in response to a significant summer wave of infections. These mRNA vaccines are anticipated to be available within days of approval, with Novavax's protein-based vaccine, targeting the JN.1 strain, expected to follow later due to longer manufacturing times. Concurrently, Pfizer and BioNTech have announced mixed results from their Phase 3 trial for a combined influenza and COVID-19 mRNA vaccine, meeting only one of two primary immunogenicity objectives. Despite higher responses for influenza A and comparable COVID-19 responses, the vaccine did not achieve non-inferiority for influenza B. Safety reviews are ongoing, and efforts to improve the combination vaccine are in discussion with health authorities.