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  1. www.pfizer.com › pfizer-biontech-covid-19-vaccine-comirnatyr-receives-fullPfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S....

    11 gru 2020 · COMIRNATY ® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:

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      The Pfizer-BioNTech COVID-19 Vaccine has received EUA from...

  2. www.fda.gov › news-events › press-announcementsFDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to...

    22 sie 2024 · Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is...

  3. www.pfizer.com › pfizer-and-biontech-announce-omicron-adapted-covid-19Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine ...

    25 cze 2022 · Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron.

  4. www.ema.europa.eu › en › newsFirst adapted COVID-19 booster vaccines recommended for approval...

    1 wrz 2022 · EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron BA.1 are for use in people aged 12 years and above who have received at least primary vaccination against COVID-19.

  5. www.ema.europa.eu › en › newsComirnaty and Spikevax: EMA recommendations on extra doses and...

    4 paź 2021 · EMA’s human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose.

  6. www.ema.europa.eu › en › newsEMA recommends authorisation of booster doses of Comirnaty from...

    24 lut 2022 · EMA’s human medicines committee (CHMP) has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age. Comirnaty is already authorised in the EU as a 2-dose primary course in adolescents 1 (as well as adults and children from 5 years of age) and a booster dose is ...

  7. www.fda.gov › pfizer-biontech-covid-19-vaccinePfizer-BioNTech COVID-19 Vaccine | FDA

    11 wrz 2023 · The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19. The Pfizer-BioNTech...