Pfizer and BioNTech requested Emergency Use Authorization from the U.S. Food and Drug Administration for a booster dose of an Omicron BA.4 and BA. 5 adapted bivalent booster for individuals ages 12 and older.
The new formula would be administered at 30 microgram doses if approved, combining the original vaccine with one that targets Omricon subvariants BA 4 and BA.5. The companies said that the bivalent vaccine will be available to ship immediately pending authorization.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “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."
According to the companies, the bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.
The company’s pre-clinical data showed that a booster dose of the bivalent vaccine generated a “strong neutralizing antibody” response against Omicron BA.1, BA.2, and BA.4/BA.5 variants, as well as the original wild-type strain.
“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,” Albert Bourla, Chairman and Chief Executive Officer, Pfizer said in a press release. “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."
A clinical study investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month.
Pfizer and BioNTech’s EAU request comes after the United Kingdom becomes the first country to approve vaccine boosters designed to target the omicron variant.
