PFE - Moderna Submits Updated COVID-19 Jab to FDA for Review | Benzinga
Moderna, Inc. (NASDAQ: MRNA) announced that it has submitted an application to the FDA seeking approval of its Spikevax 2024-2025 formula, targeting the COVID-19 variant JN.1, the latest variant of the novel virus responsible for the 2020 pandemic.
The regulatory filing is based on guidance from the FDA last week, whereby the regulatory body advised eminent vaccine manufacturers like Moderna, Novavax (NASDAQ: NVAX) and Pfizer (NYSE: PFE) to update their respective COVID-19 vaccines to a monovalent (single strain) JN.1 composition for the 2024-2025 season.
The FDA's guidance was supported by the present study data that implies currently available COVID-19 vaccines are less effective against the variants in circulation. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA also unanimously voted in a meeting held on Jun 5 to recommend a monovalent JN.1-lineage vaccine composition.This was also recommended by a World Health Organization (WHO) advisory committeeand the European Medicines Agency's Emergency Task Force.
Please note that post the WHO recommendation, other subvariants like KP.3 and KP.2 have become the dominant strains in the United States since early June. Per the agency, these new strains are JN.1-derived subvariants that contain new additional mutations. Per the agency, these subvariants provide an advantage to the virus ‘either in terms of fitness or escape from immunity.'
Of the new mutations, the VRBPAC had expressed a strong preference for vaccines to be updated with ...