FDA Approves Novavax Vaccine with Strict Limitations for Access

Washington, D.C. — The Food and Drug Administration has granted approval for the Novavax COVID-19 vaccine with strict conditions. The decision, announced on May 18, 2025, means the vaccine will only be available to older adults and individuals over the age of 12 who have specific high-risk medical conditions.

This approval follows extensive negotiations with U.S. regulators and comes after four years of clinical trials. Previously, the vaccine was authorized exclusively for emergency use. The approval contrasts with the full approval granted to vaccines developed by Pfizer-BioNTech and Moderna in 2022, which are currently administered to the general public.

The Centers for Disease Control and Prevention (CDC) has been engaged in discussions about whether COVID-19 vaccinations should focus solely on the most vulnerable populations. The FDA’s recent decision appears to partially answer that debate, aiming to restrict access in light of a rising vaccine skepticism led by Health Secretary Robert F. Kennedy Jr. and other agency leaders.

Critics are concerned the restrictions might leave healthy adults under 65 unable to obtain the vaccine, even if they wish to protect vulnerable friends or family members. Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital and a former CDC adviser, expressed her disappointment regarding the FDA’s decision. “I don’t know of any indication to make this change. This is a dark day in American medicine,” she said.

The limitations on the Novavax vaccine come as other vaccine companies are working on updated versions for the upcoming fall season. Many observers are now watching to see how this restrictive approach will impact public health and vaccination rates as new COVID strains potentially emerge.