Novavax's COVID-19 Vaccine Advances Towards Full FDA Approval

Novavax is nearing a significant milestone as its COVID-19 vaccine may soon achieve full approval from the U.S. Food and Drug Administration (FDA), according to a recent announcement from the company. This development has led to a notable surge in Novavax's stock price, which increased by over 21% in early trading following the news.

Currently, Novavax's vaccine is the only protein-based COVID-19 vaccine still available in the United States, and it has been authorized solely for emergency use. In contrast, the mRNA vaccines developed by Pfizer and Moderna have received full FDA approval for specific age demographics.

In its latest statement, Novavax indicated that the FDA has requested additional clinical data from recipients of its vaccine. The company is actively collaborating with the FDA to expedite the process and aims to secure full approval as quickly as possible.

Emergency use authorization allows for the temporary availability of vaccines, which can be withdrawn even after a declared health emergency has concluded. In contrast, full FDA approval ensures that a vaccine remains on the market even after the emergency status has been lifted. The World Health Organization officially ended the COVID-19 emergency declaration in May 2023.

Although the vaccine was initially expected to receive FDA approval by April 1, the process was paused at the direction of acting FDA Commissioner Dr. Sara Brenner. This delay raised concerns regarding potential influence from Health Secretary Robert F. Kennedy Jr., who has a history of skepticism towards vaccines. The situation became more complicated with the recent resignation of FDA vaccine chief Dr. Peter Marks, following disagreements with Kennedy over vaccine safety protocols.

U.S. COVID-19 vaccines are designed to prepare the immune system to recognize the spike protein of the SARS-CoV-2 virus. Unlike the mRNA vaccines that utilize genetic information to induce an immune response, Novavax's vaccine employs laboratory-created versions of the spike protein, combined with an immunological booster to enhance the body's response.

As part of ongoing efforts to combat emerging variants, vaccine manufacturers routinely update their COVID-19 vaccines, similar to the annual adjustments made to influenza vaccines.