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Novavax COVID vaccine gets USFDA emergency use nod for 18 years and older

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-07-14T12:14:59+05:30  |  Updated On 15 Feb 2024 10:44 PM IST
Novavax COVID vaccine gets USFDA emergency use nod for 18 years and older
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NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

Gaithersburg: Novavax, Inc., a biotechnology company, has announced that its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (USFDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and over.

"The FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This authorization reflects the strength of our COVID-19 vaccine's efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues."

"Patients and providers in the U.S. now have access to a protein-based COVID-19 vaccine backed by data that have demonstrated efficacy, safety, and tolerability," said Karen Kotloff, M.D., Professor of Pediatrics, University of Maryland School of Medicine, Associate Director of Clinical Studies at the Center for Vaccine Development and Global Health, COVID-19 Prevention Network co-lead for the PREVENT-19 trial. "Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help to increase our country's vaccination rate."

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

The FDA EUA was based on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and over 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.

Doses of the Novavax COVID-19 Vaccine, Adjuvanted were shipped from the Serum Institute of India Pvt. Ltd. and are now in the U.S. The next step for the vaccine is a policy recommendation for use from the Centers for Disease Control and Prevention (CDC).

Earlier this week, the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, announced an agreement to secure an initial 3.2 million doses of the Novavax' COVID-19 Vaccine, Adjuvanted. These vaccine doses will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

In addition to the FDA EUA, the Novavax COVID-19 vaccine has received conditional authorization for use in individuals aged 18 and over from multiple regulatory agencies worldwide, including the European Commission (EC), and emergency use listing from the World Health Organization (WHO).

Read also: Novavax COVID vaccine Nuvaxovid gets European Commission conditional nod for adolescents

NovavaxNovavax newscoronaviruscoronavirus vaccineUSFDANVX CoV2373COVID 19
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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