Pfizer seeks OK of updated bivalent Covid-19 vaccine booster for fall

Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2.

Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately. 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. “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." “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," said Prof.

Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “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 bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is.