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In September 2023, the FDA approved an updated a monovalent (single) component Omicron variant XBB.1.5 version of the vaccine (Spikevax 2023-2024 formula) as a single dose for individuals aged twelve years of age and older; [203] and authorized the Moderna COVID-19 Vaccine 2023-2024 formula under emergency use for individuals aged 6 months ...
The FDA report noted five separate observations, including that Moderna had released eight batches of "drug substance" - the active ingredient used to make mRNA vaccines - that was produced with ...
As a summer wave of Covid-19 continues to hit the United States, the US Food and Drug Administration on Thursday signed off on updated Covid-19 vaccines from Moderna and Pfizer/BioNTech.
Thursday, the FDA granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron ...
The updated Covid vaccines should be more accessible, experts say. Saturday 16 September 2023 21:00, Maggie O’Neill. The cost of the new Covid vaccines may prohibit some people from getting them ...
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday authorized updated COVID-19 vaccines from Pfizer/BioNTech and Moderna that target a recently circulating Omicron variant of the ...
On Friday, Moderna Inc. (NASDAQ:MRNA) announced that it has submitted an FDA application for review of its Spikevax 2024-2025 formula, which targets the SARS-CoV-2 variant JN.1. The submission is ...
In July 2021, the U.S. Food and Drug Administration (FDA) granted priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022. [277] [278] On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older. [33 ...