Pfizer Inc. and BioNTech announced they have completed a submission to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron adapted bivalent COVID-19 vaccine for individuals over 12 years. This application follows guidance from the US FDA to include clinical data from the bivalent Omicron adapted vaccine and pre-clinical manufacturing data from the companies.
A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron adapted bivalent COVID-19 vaccine, and is expected to be completed in the upcoming days.
Albert Bourla, CEO and chairman of Pfizer, said the agility of the mRNA platform, together with extensive clinical experience with the COVID-19 vaccine, has allowed them to develop, manufacture, and test the updated, and high-quality vaccines that align to circulate strains with unprecedented speed.
He said, they are positioned to immediately start distribution of the bivalent Omicron boosters, and if authorized, to help protect families and individuals as they prepare for potential increases in the upcoming days.
Ugur Sahin, CEO and co-founder of BioNTech, said given the evolution of COVID-19 and its variants, it is of great importance that vaccines can rapidly be adapted to the major circulating lineages of the Omicron COVID-19 variant.