Comirnaty's Full Marketing Authorization Pending in Europe

Pfizer Inc. and BioNTech SE recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization for COMIRNATY® COVID-19 Vaccine to standard Marketing Authorization (MA) for all authorized indications and formulations.

The companies stated in a media release on September 16, 2022, that the European Commission (EC) will review the CHMP recommendation and is expected to make a final decision in 2022.

The conversion, if approved by the EC, applies to all existing COMIRNATY indications and formulations authorized in the EU, including Pfizer and BioNTech’s bivalent vaccines (COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5) as booster doses for individuals aged 12 and older in the EU.

In a separate action, the CHMP also recommended approval for COMIRNATY as a 10-µg booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age.

COMIRNATY 10-µg was authorized in the EU in November 2021 as a two-dose primary series for children 5 through 11.

The third dose was well tolerated with a favorable safety profile and generated neutralizing antibodies against Omicron and the original wild-type virus, regardless of prior COVID-19 diagnosis.

The EC will review the CHMP opinion, and if MA is granted, the decision will be immediately applicable to all 27 European Union member states.