Washington, D.C. — The U.S. Food and Drug Administration (FDA) on Friday approved Novavax’s COVID-19 vaccine, Nuvaxovid, marking a significant milestone for the biotechnology company. However, the approval comes with specific usage limitations aimed at high-risk groups.
According to the FDA’s approval letter, the vaccine is authorized for use only in individuals aged 65 and older, and for those between the ages of 12 and 64 who have at least one underlying health condition that increases their risk of severe illness from COVID-19. The letter, however, did not specify which underlying conditions qualify under this criteria.
In addition, the FDA deferred pediatric studies for children under 12, citing the absence of completed data for this age group. This means the vaccine is not yet approved for use in children below the age of 12.
Novavax CEO John Jacobs hailed the approval as a “significant milestone,” emphasizing that it solidifies a clear path for vulnerable individuals to access the company’s protein-based COVID-19 vaccine.
The approval follows months of uncertainty, particularly after the FDA missed its initial April 1 deadline to greenlight the shot. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. attributed the delay to concerns related to the vaccine’s composition in a CBS interview earlier this month.
Unlike the widely used messenger RNA vaccines developed by Moderna and Pfizer, Novavax’s vaccine relies on older protein-based technology. While this approach appeals to individuals hesitant about mRNA-based vaccines, Novavax has faced considerable challenges throughout the pandemic, including manufacturing delays and regulatory setbacks, which limited its market share during the peak demand for COVID-19 vaccines.
The latest approval may help Novavax reestablish its role in the ongoing fight against COVID-19, particularly among older adults and those with underlying health conditions.
