FDA grants emergency use authorization to updated COVID vaccine
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Key takeaways:
- The updated COVID-19 vaccine targets the currently circulating Omicron variant JN.1 strain of the virus.
- The 2023 to 2024 Novavax COVID-19 vaccine is no longer authorized for use.
The FDA granted emergency use authorization for an updated version of the COVID-19 vaccine manufactured by Novavax that targets the currently circulating Omicron variant JN.1 strain of SARS-CoV-2 virus.
The authorization follows the recent approvals and authorizations from the FDA for updated mRNA COVID-19 vaccinations for 2024 to 2025 manufactured by Moderna and Pfizer.
“The COVID-19 vaccines have had a tremendous positive impact on public health, and vaccination continues to be the most effective method for COVID-19 prevention,” Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA, said in a related press release.
The updated vaccine is authorized for use by individuals aged 12 years and older who have never been vaccinated against COVID-19, who may receive two doses spaced 3 weeks apart. Individuals previously vaccinated with one dose of a Novavax COVID-19 vaccine may receive one dose of the newly authorized vaccine spaced 3 weeks after prior doses. In addition, individuals who were vaccinated with a prior COVID-19 vaccine from another manufacturer or with two or more doses of a prior Novavax COVID-19 vaccine may receive one dose of the new vaccine at least 2 months after the last dose.
Users of the updated Novavax COVID-19 vaccine may experience similar side effects as those observed with previous Novavax COVID-19 vaccines.
“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. 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,” Marks said.
As part of this action, the 2023 to 2024 Novavax COVID-19 vaccine is no longer authorized for use.
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