FDA Grants Conditional Approval to Novavax's COVID-19 Vaccine

The U.S. FDA approved Novavax's COVID-19 vaccine with conditions, allowing use for people 65 and older and those 12-64 with underlying conditions. The FDA delayed pediatric studies. The approval marks a significant milestone despite initial delays and challenges faced by Novavax due to manufacturing issues.

The FDA has granted approval for Novavax's COVID-19 vaccine, but with restrictions on eligible recipients. The conditions allow the vaccine, named Nuvaxovid, for those aged 65 and over, as well as individuals aged 12 to 64 with underlying health conditions. However, the specific conditions were not disclosed.

Despite receiving approval, Novavax still faces setbacks with delayed pediatric study submissions, as trials for children under 12 remain incomplete. This significant milestone paves the way for more people to receive the vaccine amid previous uncertainties regarding its approval timeline.

Novavax previously faced delays due to regulatory and manufacturing challenges, missing out on the broader market opportunity capitalized by competitors like Moderna and Pfizer. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. hinted at composition issues causing the delay in early April.

(With inputs from agencies.)