FDA Approves Novavax COVID Vaccine Amid HHS Leadership Changes

The U.S. Food and Drug Administration has approved Novavax's COVID-19 vaccine with significant age and health restrictions following a six-week delay. The approval, announced on May 18, limits the vaccine's use to people 65 and older and individuals 12 and older with underlying health conditions that increase their risk of severe COVID-19 illness. This represents a shift from the vaccine's previous emergency use authorization status that had been in place since 2022.

The timing of this approval coincides with changes in health department leadership under the Trump administration, with vaccine skeptic Robert F. Kennedy Jr. now heading Health and Human Services, which oversees both the FDA and CDC. According to the article, the FDA delayed its decision on Novavax as it sought additional data, with both agencies reportedly giving greater scrutiny to vaccines under the new leadership. The approval letter requires Novavax to conduct postmarketing studies on potential heart inflammation risks.

Novavax's vaccine differs from the Pfizer and Moderna options by using traditional protein-based technology rather than mRNA methods. The company's CEO John Jacobs highlighted that the approval targets populations most likely to seek seasonal COVID-19 vaccination, specifically older individuals and those with underlying conditions. Both Pfizer and Moderna vaccines received full FDA approval earlier, in 2021 and 2022 respectively, and remain available under emergency authorization for younger children.

Vaccination rates in the United States remain relatively low, with CDC data through April indicating only about 23% of U.S. adults are up to date with COVID-19 vaccines, while the rate for children is approximately 13%. The CDC is reportedly considering policy changes that would limit yearly vaccine recommendations to older individuals and those with compromised immune systems, rather than the current recommendation for everyone 6 months and older. This potential shift aligns with the more targeted approach seen in the Novavax approval.

COVID-19 monitoring has evolved significantly since the pandemic began in early 2020. Rather than tracking individual cases, the CDC now examines SARS-CoV-2 levels in sewage and collects limited data from hospitals and states. Case tracking has become more challenging as most people now use at-home tests, the results of which typically go unreported to health agencies, creating gaps in official data collection systems.