Moderna seeks US FDA authorization for updated COVID vaccine
2023.06.22 18:26
© Reuters. FILE PHOTO: A vial labelled “Moderna COVID-19 Vaccine” is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration/File Photo
(Reuters) -Moderna said on Thursday it has completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine to target the XBB.1.5 subvariant.
The submission from the company follows the FDA’s advice last week to manufacturers that are updating their COVID-19 vaccines to develop monovalent shots to target XBB.1.5.
Monovalent, or single-target, vaccines would be a change from the most recent bivalent COVID boosters that targeted both the original and Omicron strains of the coronavirus.
Moderna (NASDAQ:) said preliminary clinical data demonstrated a robust immune response by its XBB.1.5 monovalent vaccine against XBB descendent lineage viruses.
Pending authorization, the updated shot would be available in time for the fall vaccination, Moderna said.
Other COVID vaccine makers Pfizer/BioNTech and Novavax (NASDAQ:) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants.
