Unlike Pfizer/BioNTech and Moderna, Novavax does not use mRNA technology for its COVID-19 vaccine, instead opting for a recombinant version of the virus’ spike protein to elicit protection.
The FDA on Friday gave Novavax’s updated COVID-19 vaccine its emergency use authorization, marking the third booster shot available ahead of the U.S.’s fall season.
Novavax’s vaccine corresponds to the Omicron variant JN.1 strain of SARS-CoV-2 and “more closely targets” the currently circulating variants, in turn helping to prevent hospitalizations and death, according to the FDA’s announcement. Following the emergency authorization, the previous formulation of Novavax’ vaccine, covering the 2023–2024 season, is no longer authorized for use.
With Friday’s emergency authorization, Novavax now catches up to its main COVID-19 competitors Pfizer/BioNTech and Moderna, which won similar nods from the FDA in late August 2023 for their respective vaccines Comirnaty and Spikevax. As in the case of Novavax, the updated shots from Pfizer/BioNTech and Moderna are designed to elicit protection against currently prevalent strains, helping to prevent death and hospitalization.
All three vaccines can be used in adults and adolescents aged 12 years and above, including those who have been inoculated with shots from other manufacturers, given that at least two months have passed since the last vaccine dose.
Unlike Pfizer/BioNTech and Moderna’s vaccines, however, Novavax does not use mRNA technology. Instead, its vaccine contains a recombinant version of a specific viral protein, as well as an adjuvant to boost immune protection. The shot primes the body’s immune response against SARS-CoV-2’s spike protein, in turn helping it protect against COVID-19.
“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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of Novavax’s approval in a statement.
“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible,” he added, noting that vaccines, which “have had a tremendous positive impact on public health,” are still the most effective preventive option against COVID-19.
The U.S. is currently seeing a surge in COVID-19, with the Centers for Disease Control and Prevention saying that cases are “growing or likely growing” in 20 states. SARS-CoV-2’s reproduction rate is currently above 1.0, indicating that on average, infections are increasing across the country.
