Pfizer-BioNTech filed with the FDA for emergency use authorization of a 30-mcg dose of an Omicron BA.4.BA.5-adapted vaccine for those aged ≥12 years.
The companies announced Monday they completed a submission to the US Food and Drug Administration requesting an emergency use authorization of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. The vaccine would be indicated for people aged 12 years and older.
“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, said in a statement.
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.
Pfizer-BioNTech previously announced safety, tolerability and immunogenicity data from a phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate, which combines the existing vaccine and a vaccine targeting the Omicron BA.1 variant spike protein. The Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 variant compared to the companies’ current COVID-19 vaccine. The Omicron BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile.
The companies’ timeline for vaccine availability can be as early as next month. They have increased production of the vaccine, and will begin shipping immediately pending authorization.
“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," Bourla said.