Moderna seeks US FDA authorization for updated COVID-19 vaccine | Inquirer News

Moderna seeks US FDA authorization for updated COVID-19 vaccine

/ 07:00 AM June 23, 2023

Moderna says it has completed a submission to the USFDA seeking authorization for its updated COVID-19 vaccine to target the XBB.1.5 subvariant.

FILE PHOTO: A vial labeled “Moderna COVID-19 Vaccine” is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration/File Photo

Moderna said Thursday it has completed a submission to the United States 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.

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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.

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Moderna said preliminary clinical data demonstrated a robust immune response by its XBB.1.5 monovalent vaccine against XBB descendent lineage viruses.

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Pending authorization, the updated shot would be available in time for the fall vaccination, Moderna said.

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Other COVID vaccine makers Pfizer/BioNTech and Novavax are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants.

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TAGS:  XBB.1.5, COVID-19, Moderna, Omicron, vaccine

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