On Friday, the FDA granted emergency use authorization to Novavax Inc. (NASDAQ: NVAX) COVID-19 Vaccine, Adjuvanted (2024-2025 Formulation) (NVX-CoV2705) for active immunization to prevent COVID-19 in individuals 12 years of age and older.
The Novavax vaccine is included in the recommendations issued by the US Centers for Disease Control and Prevention (CDC) on June 27, 2024.
After the vaccine lots are released by the Center for Biologics Evaluation and Research, prefilled syringes of the vaccine will be available at thousands of locations, including retail and independent pharmacies and regional grocers.
Also read: FDA approves updated COVID vaccines from Pfizer and Moderna, but leaves out Novavax vaccine
“Our updated vaccine targets JN.1, the ‘parent strain’ of the currently circulating variants, and has shown strong cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1,” said John C. Jacobs, President and CEO of Novavax.
In June, the CDC’s Advisory Committee on Immunization Practices voted unanimously to recommend universal use of EUA-authorized or Biologics License Application-approved 2024-2025 COVID-19 vaccines in individuals six months of age and older, regardless of specific viral strains.
The approval is based on nonclinical data that showed Novavax’s updated vaccine provides protection and cross-reactivity against JN.1 and multiple JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
Novavax says its vaccine is the only protein-based option available in the United States for people ages 12 and older to prevent COVID-19.
Doses are expected to be available by the end of next week, the company said in an email to Reuters.
In August, Novavax lowered its 2024 revenue guidance to $700 million to $800 million, including recognition of Sanofi Payment revenue, compared to consensus of $936.38 million.
Previously, the company had expected revenue of $970 million, or $1.17 billion in combined revenue and payment from the Sanofi deal.
Price action: NVAX stock was up 3.30% at $12.79 at last check Tuesday.
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This article FDA Approves Novavax’s Updated COVID Vaccine Targeting Currently Circulating Variants originally appeared on Benzinga.com
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