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U.S. CDC Advisory Committee Unanimously Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Primary Series for Individuals Aged 18 and Older
Recommendation follows U.S. FDA Emergency Use Authorization for the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary seriesFDA has determined that
About this update from Novavax, Inc.
[{"type":"text","content":"Recommendation follows U.S. FDA Emergency Use Authorization for the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary seriesFDA has determined that first vaccine lot has met all release specifications and is acceptable for use under Emergency Use AuthorizationNovavax expects to ship doses to the U.S. Government-designated distribution center in the coming daysNovavax' vaccine is the first FDA-authorized and ACIP-recommended protein-based COVID-19 vaccine in the U.S.GAITHERSBURG, Md., July 19, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the use of the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary series in individuals aged 18 and older.\nThe recommendation follows the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA). ACIP will submit its recommendation to the Director of the CDC for review and endorsement.\n\"We think vaccine choice is important, particularly as we expect to see ongoing surges of COVID-19 and work to increase vaccination rates,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"With demonstrated efficacy and a reassuring safety profile, our vaccine is the country's first protein-based option.\"\nThe Committee based its recommendation on use in individuals aged 18 and older on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled 29,960 participants aged 18 years and older in the U.S. and Mexico. In the trial, the Novavax COVID-19 Vaccine, Adjuvanted demonstrated 90.4% efficacy (95% confidence interval [CI], 83.8% to 94.3%; P","length":3053,"tagName":"div"}]