Pfizer (NYSE:PFE) and German partner BioNTech (NASDAQ:BNTX) on Friday said they had completed a submission to Europe’s drug regulator for a booster dose of their Omicron-subvariant adapted bivalent COVID-19 vaccine.
The submission to the European Medicines Agency (EMA) comes just days after the companies applied for an emergency use approval of the bivalent shot to the U.S. FDA.
All components of the bivalent vaccine are unchanged from the original Comirnaty shot, except for the addition to the mRNA of the Omicron BA.4/BA.5 spike protein sequence, the companies said in a statement.
Both the Omicron BA.1-adapted and BA.4/BA.5 adapted boosters will be available as early as Sept. if approvals are received, PFE and BNTX said.
The U.S. and Europe are gearing up for COVID vaccination campaigns for the fall and winter, in which the BA.4/BA.5 subvariants are expected to be the dominant circulating strains.
PFE stock -0.5% to $47.65 in morning trading, while U.S.-listed shares of BNTX were 0.9% lower at $147.23.