FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots

The Trump administration’s move to impose new requirements on Novavax’s COVID-19 vaccine, the only traditional protein-based option in the country, is causing uncertainty about potential updates to other vaccines as well. Novavax announced on Monday that the Food and Drug Administration requested a new clinical trial for its vaccine following full approval. The company stated it had responded and believed its vaccine was still eligible for approval.

However, a social media post over the weekend by FDA Commissioner Marty Makary hinted at the need for a new trial before the annual strain update for the vaccines, which may not be feasible before fall. This has led to concerns about the impact on other vaccines. Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, argued that considering a strain change as a new product could lead to a perpetual cycle of clinical trials, hindering the timely update of vaccines.

The FDA’s unusual actions come after the departure of the agency’s longtime vaccine chief due to disagreements with Health Secretary Robert F. Kennedy Jr., who vowed not to alter the nation’s vaccine schedule during his confirmation. The Novavax vaccine is currently available under emergency use authorization in the U.S., while the mRNA vaccines from Pfizer and Moderna have received full FDA approval for certain age groups.

Given the continuous mutations of the coronavirus, manufacturers are required to make yearly adjustments to their vaccines based on FDA instructions, similar to the process for flu vaccines. Although Novavax was expected to receive full approval by April 1, recent directives from Trump appointees led to a pause in the decision, with discussions ongoing between Novavax and the FDA regarding additional approval requirements.

In a tweet, FDA’s Makary referred to the updated Novavax vaccine as a “new product” due to its alignment with last year’s prevalent coronavirus strain, indicating the need for new clinical studies for such updates. An administration spokesman hinted at the possibility of stricter requirements for all COVID-19 vaccines, emphasizing the diminished urgency for rushed booster approvals.

Dr. Paul Offit, a vaccine expert, highlighted that while the updated vaccines undergo testing to ensure protective antibody levels and safety, they are not treated as entirely new products but as adjusted versions to combat the latest strains. Xavier Becerra, former Health Secretary, noted the extensive real-world data from the administration’s vaccination efforts, emphasizing the substantial clinical trial conducted through vaccine distribution.