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  1. 27 cze 2024 · Pfizer and BioNTech are starting rolling applications with the U.S. Food and Drug Administration (FDA), per recent FDA recommendation, requesting approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals 6 months of age and older.

  2. 17 cze 2024 · The most recent update was recommended by FDA on June 5, 2024: Monovalent COVID-19 vaccines coming this fall/winter season should contain an antigen against JN.1. This FAQ covers that update and the reasons for FDA’s recommendation.

  3. 13 cze 2024 · Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the...

  4. 6 dni temu · The first, issued in November 2020, covered clinical requirements for COVID-19 vaccine approval, and the second, issued in February 2021, addressed quality, non-clinical, clinical and clinical requirements for SARS-CoV-2 variant vaccines.

  5. 6 dni temu · The CDC recommends that everyone 6 months and older get an updated COVID vaccine when they become available this fall. The shots should be ready by August or September. Vaccines from Pfizer and Moderna will target the KP.2 variant, while Novavax will target JN.1. The Centers for Disease Control and Prevention (CDC) on Thursday recommended that ...

  6. 27 cze 2024 · The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older

  7. 10 cze 2024 · Moderna (MRNA) completes regulatory filing of its Spikevax 2024-2025 formula, targeting the COVID-19 variant JN.1 to the FDA for the upcoming vaccination season.

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