Pfizer- BioNTech get positive CHMP opinion for conversion of COMIRNATY conditional marketing nod to full marketing nod in 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. The 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.