FDA Not Recommending Newly Approved COVID-19 Vaccine: Official

The FDA has approved a new COVID-19 vaccine from Moderna, but is not recommending it for use. The agency's top vaccine officials, Dr. Vinay Prasad and Dr. Marty Makary, clarified that the FDA's role is to make vaccines available, not to recommend them to individuals. The new vaccine is cleared for people 65 and older, and those 12 to 64 with certain health conditions. The CDC recently stopped recommending COVID-19 vaccines for healthy children and pregnant women. The FDA typically authorizes and approves vaccines, while the CDC issues vaccine recommendations. Dr. Prasad emphasized that the FDA is not in the business of making recommendations, but rather grants marketing authorization for vaccines. The agency approved the new vaccine based on data showing it triggered non-inferior immune responses compared to Moderna's already-available COVID-19 shot. Moderna has committed to running a placebo-controlled trial of the new vaccine among healthy people aged 50 to 64, which the FDA will scrutinize closely. The trial will assess the vaccine's effectiveness and safety, including adverse events.