BioNTech and Pfizer say their adapted COVID-19 vaccine, to fight Omicron subvariants BA.1 and BA.4/5, could be delivered by October. File photo by Debbie Hill/UPI | License Photo
Aug. 8 (UPI) -- BioNTech and Pfizer announced trials Monday for their adapted COVID-19 vaccines, to fight faster-spreading Omicron subvariants BA.1 and BA.4/5, which could be ready for fall boosters as early as October.
"BioNTech and Pfizer have started to manufacture bivalent Omicron BA.1 and BA.4/5-adapted vaccines," BioNTech said in its financial results statement Monday. "Pending regulatory approval, the companies expect to deliver the updated vaccines as soon as October 2022 and plan to supply both vaccines in time for fall booster campaigns."
BioNTech and its American partner Pfizer said vaccine trials will begin this month.
"Subject to regulatory approval, Omicron-adapted vaccine launches and clinical trial starts, including trials for next generation vaccines, are expected to begin in the second half of 2022," the German biotechnology company said in the statement. "The companies are currently evaluating variant-adapted COVID-19 vaccines, including monovalent and bivalent vaccines directed against Omicron subvariants and other strains of SARS-CoV-2."
The announcement comes after Moderna announced in June its revamped COVID-19 booster shot to fight Omicron subvariants could be ready as early as this month. Moderna has been making shots of the vaccine, called mRNA-1273.214, before getting regulatory approval so it will be ready to ship doses out for the fall and winter, when health experts worry there could be another wave of COVID-19.
In June, the Food and Drug Administration urged drug makers to adapt their vaccines to new COVID-19 strains, but have yet to approve any of the new boosters. The FDA will not require updated clinical trial data for the BA.4/BA.5 adapted shots, but will require data from the BA.1 vaccine trials to approve the vaccines.
Pfizer and BioNTech have already submitted findings to the FDA from their clinical trials for the BA.1 Omicron vaccine, which was shown to produce higher neutralizing antibodies against the variant.
"In June 2022, BioNTech and Pfizer announced positive safety, tolerability and immunogenicity data for two Omicron BA.1-adapted vaccine candidates," the statement said. This includes "data on a monovalent and a bivalent vaccine candidate combining the existing vaccine and a vaccine candidate targeting the Omicron variant BA.1 spike protein."