FDA EUA Sought by Pfizer-BioNTech for Omicron Booster
Pfizer-BioNTech hopes booster can be available for use this fall.
As autumn approaches with possibilities of COVID-19 surges, Pfizer and BioNTech are seeking federal emergency use authorization (EUA) for a booster vaccine against the Omicron BA.4/BA.5 variant.
The U.S. Food and Drug Administration will consider EUA for a booster dose for people aged 12 years and older and if approved, the vaccine will be available to ship immediately, according to the announcement from the companies.
“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 Chairman and CEO Albert Bourla said in a news 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 conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.
“Given the ongoing evolution of SARS-CoV-2 and its variants, it's of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” BioNTech CEO and cofounder Prof. Ugur Sahin, MD, said in the news release. “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”
The Pfizer and BioNTech announcement said the bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant. “Preclinical data showed a booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response” against the Omicron variants and the original strain.
