BRIEF—New Comirnaty COVID-19 vaccine booster cleared in Canada

Medicines regulator Health Canada has authorized Comirnaty Original & Omicron BA.4/BA.5 as a 30μg booster dose for individuals ages 12 years and older.

The vaccines are based on BioNTech’s proprietary mRNA technology, and were developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder for BNT162b2 in Canada, the USA, the European Union, the UK and other countries, and the holder of emergency use authorizations or equivalents in the USA (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.

An application for an Omicron BA.4/BA.5-adapted bivalent vaccine for children five through 11 years of age is also being planned for submission to Health Canada for review.