Novavax has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated Covid-19 vaccine, NVX-CoV2705, joining other vaccine manufacturers in addressing evolving virus variants. The EUA permits the use of Novavax’s updated vaccine in individuals aged 12 years and older. This approval follows the FDA’s recent authorizations of two updated mRNA vaccines—Moderna’s Spikevax and Pfizer/BioNTech’s Comirnaty—for use in the same age group and, additionally, in children aged six months to 11 years.
Covid-19 Vaccine
The updated Novavax vaccine targets the Omicron variant JN.1 strain of SARS-CoV-2, and according to Novavax CEO John C. Jacobs, it demonstrates strong cross-reactivity against several related variants, including KP.2.3, KP.3, KP.3.1.1, and LB.1. This development aligns with recommendations made by the FDA’s Vaccines and Related Biological Products Advisory Committee in June, which suggested that the 2024-2025 Covid-19 vaccine formulas should include a monovalent JN.1 component.

Despite these updates, the overall demand for Covid-19 vaccines has significantly decreased over the past year. Both Pfizer and Moderna have experienced sharp declines in sales, with Pfizer’s 2023 revenue dropping by 42% compared to the previous year, prompting cost-saving measures. Moderna reported a 64.8% decrease in revenue for 2023, highlighting the broader market challenges faced by vaccine manufacturers.

Pfizer and BioNTech are also exploring new avenues, including the development of a combination mRNA vaccine targeting both influenza and Covid-19. However, this combination therapy recently did not meet one of its two primary endpoints in a Phase III trial.

In May, Novavax entered into a $1.2 billion licensing agreement with Sanofi, granting the latter global commercialization rights for its adjuvanted Covid-19 vaccine, except in markets where Novavax already has existing partnerships, such as India, South Korea, and Japan.

Novavax’s EUA for its updated Covid-19 vaccine arrives amid a backdrop of strategic shifts and continued efforts to address the evolving landscape of Covid-19 variants. The updated vaccine, distinguished as the only protein-based Covid-19 vaccine available in the U.S., utilizes noninfectious copies of the Covid spike protein to prime the immune system. While Moderna and Pfizer’s boosters target the KP.2 variant, Novavax’s shot is aimed at the parent JN.1 strain, which has demonstrated robust cross-reactivity against multiple circulating variants.

This authorization enables Novavax to make its updated vaccine available in pre-filled syringes at numerous locations across the United States, expanding the options for Covid-19 vaccination in the country.

Source:
https://finance.yahoo.com/news/novavax-wins-fda-emergency-approval-145333025.html
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