Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

Novavax's shot is now fully approved in the U.S. Since 2022, the vaccine has been used under an emergency use authorization. Health experts consider it a valuable alternative to messenger RNA shots from Pfizer and Moderna, which have been far more popular among Americans.

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.