Novavax COVID Vaccine Approaches Full FDA Approval in the United States

Novavax's COVID-19 vaccine is moving closer to achieving full approval from the U.S. Food and Drug Administration (FDA), according to statements made by the company on April 25, 2025. This development has positively impacted Novavax's stock, which surged over 21% in early trading, and is seen as a significant step in the vaccine's journey beyond emergency use authorization.

Currently, Novavax's vaccine remains available in the U.S. under emergency use authorization (EUA), differing from the Pfizer and Moderna vaccines, which have obtained full FDA approval for specific age groups. The company disclosed that the FDA has requested additional clinical data from recipients of the vaccine as part of the approval process. In response, Novavax has stated it is engaging with the FDA expeditiously to obtain full approval as soon as possible.

Securing full FDA approval is a critical step because it allows the vaccine to remain on the market even after the end of the public health emergency—something that is particularly relevant now that the World Health Organization declared an end to COVID-19's global emergency in May 2023. During the initial approval phase, the process was halted in April, leading to speculations about possible influences, including recent political figures and internal disagreements within the FDA regarding vaccine safety.

Unlike mRNA vaccines from Pfizer and Moderna, which use genetic material to instruct cells to produce the spike protein, Novavax's vaccine employs lab-grown copies of the spike protein combined with an immune-boosting agent. This protein-based approach offers an alternative method for training the immune system against COVID-19 and is the only one of its kind currently available in the U.S.

Given the ongoing need to adapt to new virus variants, vaccine manufacturers routinely update their COVID-19 shots annually, similar to flu vaccines, to enhance protection. As Novavax progresses towards full FDA approval, it signifies a continued effort to expand vaccine options and bolster COVID-19 defenses in the United States.