FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines …
WEBAug 22, 2024 · The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID...
Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives …
WEBAug 23, 2021 · COMIRNATY is the first COVID-19 vaccine to be granted FDA approval ; Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose; More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories around the world since December 2020
Pfizer and BioNTech Provide Update on mRNA-based …
WEBAug 16, 2024 · Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines.
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better …
WEBSep 11, 2023 · Approval of Comirnaty (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, and a change to a single dose for individuals 12 years of age and older.
Pfizer and BioNTech Announce Positive Topline Data for mRNA …
WEBOct 26, 2023 · *COMIRNATY (2023-2024 Formula) is made the same way as Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).
FDA Approves First COVID-19 Vaccine
WEBThe vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years...
Comirnaty - European Medicines Agency (EMA)
WEBDec 21, 2020 · Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The originally authorised Comirnaty contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.
Pfizer COVID-19 Vaccine Summary | Vaccines & Immunizations
WEBAug 28, 2024 · FDA approved the updated 2024-2025 formula of COMIRNATY on August 22, 2024. FDA also granted emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine 2024-2025 Formula on August 22, 2024.
Comirnaty: EMA recommends approval of adapted COVID-19 …
WEBAug 30, 2023 · EMA’s human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. The vaccine – known as Comirnaty Omicron XBB.1.5 – is to be used for preventing COVID-19 in adults and children from 6 months of age.
MHRA approves Comirnaty JN.1 COVID-19 vaccine for adults and …
WEBJul 24, 2024 · The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 24 July, approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the JN.1 COVID-19 subvariant.