Pfizer: Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for COMIRNATY® [COVID-19 Vaccine (nucleoside modified)] to standard (also referred to as “full”) Marketing Authorization (MA) for all authorized indications and formulations. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

The recommendation to convert the cMA to full MA is based on the totality of available efficacy and safety data provided by Pfizer and BioNTech, which confirm the benefits of the vaccine continue to outweigh its potential risks. 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 years of age. Today’s recommendation is based on Phase 2/3 clinical data from participants 5 through 11 years of age who received a 10-µg booster dose of COMIRNATY approximately 6 months after completing the two-dose primary series. The third dose was well tolerated with a favorable safety profile and generated neutralizing antibodies against both 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.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.