FDA Grants Full Approval to Novavax COVID-19 Vaccine for High-Risk Adults

The U.S. Food and Drug Administration (FDA) has officially granted full approval to Novavax's COVID-19 vaccine, but this approval comes with specific restrictions. The vaccine is now authorized for use in adults aged 65 and older, as well as individuals aged 12 to 64 who have existing health conditions that increase their risk of severe COVID-19 illness. Prior to this, Novavax's vaccine was available in the U.S. only under emergency use authorization for individuals 12 and above, making it the only protein-based COVID-19 vaccine currently approved in the country.

This decision marks a significant milestone for Novavax, highlighting the vaccine's safety and efficacy based on data from a large clinical trial involving 30,000 participants. However, the FDA chose not to extend the approval to broader populations and instead requested additional studies. These upcoming studies aim to assess potential links between the vaccine and heart-related issues and to determine its benefits for healthy adults aged 50 to 64.

The restriction to high-risk groups has raised questions, especially since other COVID-19 vaccines like those from Pfizer and Moderna are approved for broader age groups, including children as young as six months. The reasons behind the FDA's decision to limit Novavax's approval are not explicitly stated, but it aligns with some skepticism among certain officials about the widespread use of COVID-19 vaccines.

Novavax’s CEO, John Jacobs, expressed optimism regarding the approval, emphasizing that the company's focus remains on providing vaccination options tailored to specific populations, particularly older adults and those with underlying health conditions. The approval process reflects ongoing efforts by health authorities to balance safety, efficacy, and vaccine supply amid the evolving pandemic.

Looking ahead, the CDC’s advisory committee will soon review and recommend strategies for COVID-19 booster shots. The recent FDA approval may influence these policy decisions, shaping the future direction of vaccination efforts in the United States.

For more information about COVID-19 vaccine guidance, visit the CDC's official site. This development signifies an important step in the continued fight against COVID-19, especially for vulnerable populations.

Source: https://medicalxpress.com/news/2025-05-fda-full-novavax-covid-shot.html