FDA: [August 30, 2024] The U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2. “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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.” This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2024-2025 manufactured by ModernaTX Inc. and Pfizer Inc.” [h/t Pete Weiss]
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