• The FDA has approved the Novavax COVID-19 vaccine with new limitations restricting usage.
• The vaccine is now only available to those aged 65 and older or individuals 12 and over with certain health conditions.
• The decision reflects ongoing debates among health officials about vaccination strategies.

The U.S. Food and Drug Administration (FDA) has granted approval for Novavax's COVID-19 vaccine, but with strict new conditions specifying its availability only to individuals aged 65 and older and those 12 and over with underlying health conditions that pose a high risk from COVID-19. This decision limits access for healthier individuals under 65 and may create concerns about the safety of this population if more virulent virus strains arise, according to The New York Times and Reuters.

Novavax had initially received emergency authorization for its vaccine, which, being the only traditional protein-based vaccine available, differs from the messenger RNA vaccines produced by Pfizer and Moderna, which gained full approval in 2022. The FDA’s new restrictions appear to be influenced by the prevailing skepticism towards vaccines from Health Secretary Robert F. Kennedy Jr. and his appointments in health agencies, as noted by Reuters and HuffPost.

Analysts have described the conditions as unusual yet consistent with expectations, and Novavax CEO John C. Jacobs referred to the approval as a significant milestone aimed at the most vulnerable populations. However, some have expressed disappointment, emphasizing that the limitations may hamper broader accessibility. Dr. Camille Kotton, an infectious disease physician, criticized the move, stating it leaves many unprotected, according to India Times and The New York Times.