The use of the BioNTech / Pfizer vaccine against Covid-19 (named Comirnaty) in children aged 5 to 11 years will be considered at an extraordinary meeting on Thursday by the European Medicines Agency (CHMP) Committee on Medicinal Products for Human Use.
The Agency’s committee will review data on the vaccine, including the results of an ongoing clinical trial involving children aged 5 to 11, to decide whether to propose extending its use. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.
The EMA will announce the outcome of its assessment, which is expected in a few months, unless additional information is needed.
Comirnaty was first approved in the EU in December 2020.
Pfizer Inc. also announced Monday that its Covid-19 vaccine offered strong long-term protection against the virus in a last-stage study of 12- to 15-year-olds.
The EMA also announced that it was evaluating the booster dose of the Janssen vaccine. It should be given at least two months after the first dose to people 18 years of age and older.
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