Pfizer and BioNTech on Monday submitted a request to the U.S. Food and Drug Administration to receive an emergency use authorization for an updated COVID-19 booster shot that targets the omicron BA.4/BA.5 variants.

What You Need To Know

  • Pfizer-BioNTech asked U.S. regulators Monday to authorize its combination COVID-19 vaccine that adds protection against the newest omicron relatives

  • Earlier this year, the Food and Drug Administration ordered vaccine makers to tweak their shots to target BA.4 and BA.5, which make up the majority of new infections

  • The booster would be available for individuals aged 12 years and older and aims to “address the continued evolution of SARS-CoV-2,” the companies wrote in a statement

  • If the FDA quickly clears the combo shots made by Pfizer and its partner BioNTech, boosters could be offered within weeks

The booster would be available for individuals aged 12 years and older and aims to “address the continued evolution of SARS-CoV-2,” the companies wrote in a statement. 

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Pfizer CEO Albert Bourla wrote in part. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges." 

The new booster dose includes the mRNA encoding from the companies’ previously-approved COVID-19 vaccine, as well as encoding that targets the specific spike protein present in the BA.4 / BA.5 variants of the omicron strain of SARS-CoV-2. According to data from preclinical trials, Pfizer-BioNTech said individuals who received the booster dose showed “a strong neutralizing antibody response” against omicron variants BA.1, BA.2 and BA.4/BA.5, as well as the original wild-type virus. 

Advisers to the FDA earlier this year voted 19-2 that any new COVID-19 boosters should contain some version of the super-contagious omicron variant, to be ready for an anticipated fall booster campaign.

According to the World Health Organization, the latest global surge of COVID-19 has been driven by omicron subvariant BA.5, which is responsible for about 70% of the virus samples shared with the world’s largest public virus database. The subvariant BA.5 is even more infectious than the original version of omicron and has some genetic differences that earlier vaccines might not address.

If the FDA quickly clears the combo shots made by Pfizer and its partner BioNTech, boosters could be offered within weeks. The U.S. has a contract to buy 105 million of the updated Pfizer doses as soon as health authorities greenlight them, and the company said doses are ready to ship.

Moderna is expected to file a similar application soon, and the U.S. has a contract to buy 66 million doses of its updated vaccine.

For now at least. BA.5 currently is causing nearly all COVID-19 infections in the U.S., and much of the world. There’s no way to know if it still will be a threat this winter – or if another mutant will have replaced it.

The news comes after Britain a week ago became the first in the world to authorize a different update to Moderna’s COVID-19 vaccines -- shots that add protection against the original omicron that struck last winter.

The U.S. opted not to use that earlier tweak to the vaccine – setting up a fall where different countries will be using different versions of booster shots to rev up protection against another possible winter surge.

The Associated Press contributed to this report.