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CHMP recommends approval of Comirnaty as booster dose for COVID-19.

Read time: 1 mins
Last updated:8th Oct 2021
Published:6th Oct 2021
Pfizer and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of Comirnaty, the companies’ COVID-19 vaccine, as a booster dose at least six months after the second dose in individuals 18 years of age and older.

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future.

The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. The data submitted by BioNTech and Pfizer include data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of Comirnaty. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for Comirnaty.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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