As of May 18, 2025, Novavax's COVID-19 vaccine has yet to secure full approval from the U.S. Food and Drug Administration (FDA). The company is making efforts to meet the FDA's requirements for full licensure. Currently, the vaccine is available under Emergency Use Authorization in the United States.
In April 2025, the FDA requested that Novavax conduct an additional clinical trial to demonstrate the vaccine's effectiveness, which has caused delays in the full approval process. Meanwhile, Reuters reported that in May 2025, Novavax reassured its investors about progressing toward FDA approval, highlighting ongoing discussions with the regulatory body to address any unsettled issues.
Despite these challenges, Novavax remains focused on securing FDA approval and is collaborating with the agency to meet the necessary criteria. The company's stock is currently trading at 6.73 USD, showing a slight increase from the previous close, with a trading high of 6.88 USD and a low of 6.16 USD on the latest market data.