FDA Authorizes Updated Novavax COVID-19 Vaccine

The Food and Drug Administration (FDA) on Tuesday authorized an updated COVID-19 vaccine by Novavax for people ages 12 years and older.

The announcement comes three weeks after regulators approved the updated shots by Moderna and Pfizer.

Unlike Pfizer and Moderna, which use mRNA technology for their vaccines, Novavax uses a more traditional protein-based vaccine technology. Some scientists say Novavax offers a valuable and effective alternative for people who are uncomfortable getting an mRNA vaccine.  

Previously, the FDA and Centers for Disease Control and Prevention (CDC) said that people could only get the Novavax shot if they had not had a primary series from Pfizer, Moderna, or Johnson & Johnson, or if they had a primary series and only one booster and refused to get additional mRNA boosters.

Now, anyone ages 12 years and older who was previously vaccinated against COVID-19 can receive one dose of the updated Novavax vaccine, and anyone who is unvaccinated get can two doses, as long as they haven’t yet received an updated Pfizer or Moderna shot.

“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

In a break from the traditional order of events, the CDC and its expert advisory panel had already recommended the vaccine before the FDA authorization. That means the company has all the regulatory approval it needs to start distributing vaccine doses.

Novavax said shots will soon be available at doctors’ offices, clinics, and local and national pharmacies, including at CVS Pharmacy and Rite Aid.

Like the Moderna and Pfizer vaccines, the Novavax shot is monovalent, meaning it protects against one variant of COVID-19. In this case, it is designed to neutralize XBB.1.5, a variant that was dominant in early summer, when the formulations were decided upon. Non-clinical studies show that the vaccine can protect against currently circulating variants, too.

"COVID-19 is once again on the rise with infections and hospitalizations increasing, so it's important that individuals get vaccinated to protect themselves and their loved ones," John C. Jacobs, President and Chief Executive Officer at Novavax, said in a statement. "Novavax's authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against COVID-19, which is now the fourth leading cause of death in the U.S."

According to the company and the CDC, the most common side effects associated with the vaccine include headache, nausea, muscle pain, joint pain, injection site pain, and fatigue.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.