#26731
Re: Novavax (NVAX): Un Nuevo Comienzo
U.S. CDC Advisory Committee Unanimously Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Primary Series for Individuals Aged 18 and Older
https://ir.novavax.com/2022-07-19-U-S-CDC-Advisory-Committee-Unanimously-Recommends-Novavax-COVID-19-Vaccine,-Adjuvanted-as-a-Primary-Series-for-Individuals-Aged-18-and-Older
https://ir.novavax.com/2022-07-19-U-S-CDC-Advisory-Committee-Unanimously-Recommends-Novavax-COVID-19-Vaccine,-Adjuvanted-as-a-Primary-Series-for-Individuals-Aged-18-and-Older
Jul 19, 2022
- Recommendation follows U.S. FDA Emergency Use Authorization for the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary series
- FDA has determined that first vaccine lot has met all release specifications and is acceptable for use under Emergency Use Authorization
- Novavax expects to ship doses to the U.S. Government-designated distribution center in the coming days
- Novavax' 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.
The 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.
"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."
The 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<0.001) with a reassuring safety profile. Among participants 18 through 64 years of age, solicited adverse reactions (ARs) following administration of any dose of the vaccine, were injection site pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%), headache (52.9%), joint pain (25.4%), nausea/vomiting (15.6%), injection site redness (7.0%), injection site swelling (6.3%), and fever (6.0%). In participants ≥65 years of age, solicited ARs following administration of any dose of the vaccine were injection site pain/tenderness (63.4%), fatigue/malaise (39.2%), muscle pain (30.2%), headache (29.2%), joint pain (15.4%), nausea/vomiting (7.3%), injection site swelling (5.3%), injection site redness (4.8%), and fever (2.0%).
In addition to the FDA EUA, the Novavax COVID-19 vaccine has received conditional authorization for use in individuals aged 18 and older from multiple regulatory agencies worldwide, including the European Commission (EC), and Emergency Use Listing from the World Health Organization.
This project has been supported in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number MCDC2011-001.
