EMA Starts Evaluation of Comirnaty in Children

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EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

The European Medicines Agency (EMA) has commenced its evaluation of the BioNTech-Pfizer COVID-19 vaccine, Comirnaty, in children who are aged between five years and 11 years old, to determine if it can be authorized for further expanded use.

According to an Oct. 18, 2021 press release, EMA’s Committee for Medicinal Products for Human Use (CHMP) will review available data on the vaccine, which include results from a clinical study involving children between five and 11 years old that is ongoing. Once CHMP has formed a decision on whether or not an extension of the use of Comirnaty is appropriate it will forward all information onto the European Commission for a final decision.

EMA has specified in the press release that it will “communicate on the outcome of its evaluation, which is expected in a couple of months unless supplementary information is needed.”


Source: EMA