Source: Associated Press
“The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. … the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19. … the FDA didn’t explain the restrictions although they reflect skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions — by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters.” [editor’s note: I was one of those clinical trial participants – TLK] (05/17/25)
https://apnews.com/article/novavax-covid19-vaccine-fda-a477c1aa612ceb293e70d904b46611b0