Pfizer said on Monday that it has submitted an application to the Food and Drug Administration (FDA) for an updated COVID-19 vaccine targeting the Omicron subvariant, The Hill reported.
The application comes ahead of a fall booster shot campaign. Assuming the FDA signs off, the shots are expected to begin in September, according to the report.
The application, per instructions previously given by FDA, is for a “bivalent” vaccine that targets the BA.4 and BA.5 subvariants of omicron currently circulating, as well as the original form of the virus.
“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, Pfizer’s CEO, said in a statement.
“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,” he added.
The application is for everyone 12 years of age and older.
In January, Pfizer and BioNTech began enrollment for a clinical trial to test the safety and immune response of their Omicron-specific COVID-19 vaccine.
Bourla said last November that three doses of the original Pfizer vaccine would remain effective even against the Omicron variant of the coronavirus, but added that a new vaccine specifically made to combat the new strain could be ready in 100 days.