The US Food and Drug Administration has approved Novavax’s traditional protein-based COVID-19 vaccine, but with unusual age restrictions. The vaccine is now licensed only for use in adults 65 years old or older, or those between 12 and 64 with underlying health conditions that increase their risk of severe illness from COVID-19.
This decision comes after a clinical trial involving 30,000 participants showed the vaccine to be safe and effective. However, the FDA has imposed additional requirements for Novavax, including an extra trial to assess potential heart condition associations and another study to evaluate the benefits of continued vaccination in high-risk populations within this age group.
Novavax CEO John C. Jacobs welcomed the approval, citing market research that indicates older individuals and those with underlying conditions are more likely to seek COVID-19 vaccination. The decision may have been made ahead of a CDC advisory committee meeting scheduled for next month, where experts will debate whether yearly COVID vaccines should be recommended for everyone or just high-risk groups.
Source: https://www.pbs.org/newshour/health/fda-approves-novavax-covid-19-vaccine-but-with-unusual-restrictions-on-its-use