Pfizer/BioNTech request “emergency use” authorisation from FDA for Omicron-specific jab

Pfizer/BioNTech request "emergency use" authorisation from FDA for Omicron-specific jab

Pfizer/BioNTech request "emergency use" authorisation from FDA for Omicron-specific jab. Image: Ververidis Vasilis/

VACCINE manufacturers Pfizer and BioNTech revealed on Monday, August 22 that they have submitted a request to the FDA for “emergency use” authorisation of its Omicron-specific mRNA injection.

“Pfizer and BioNTech today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorisation (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older,” a statement read.

“The application follows guidance from the FDA to include clinical data from the companies’ bivalent 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.”

It added: “A conditional marketing authorisation 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.”

Pfizer CEO Albert Bourla, who recently revealed he had tested positive for Covid despite being quadruply vaccinated, said: “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.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorised, to help protect individuals and families as we prepare for potential fall and winter surges.” 

Professor Ugur Sahin, M.D., CEO and Co-founder of BioNTech said: “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.

“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.”

Pfizer’s Covid vaccine was authorised by the FDA for “emergency use” on December 11, 2020.

Following the news, people took to social media to react.

One person said: “When are they actually going to use the FDA-approved version of comirnaty? Its never been distributed they still use the EUA labels. One starts to wonder seriously wonder whether they have any faith at all in this first product. They won’t distribute it under an already approved label. There’s some reason why.”

“They still going on about it? Already made billions,” said another.

“Makes little sense as omicron is on its last legs now with BA5 cases beginning to fall most countries. So by time this is out a new variant will exist,” wrote another Twitter user.

While another person said: “What’s Your Emergency 🤔”

The news of Pfizer/BioNTech’s request to the FDA comes on the same day that NIAID director and chief medical advisor to Biden, Dr Anthony Fauci announced his retirement.

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Written by

Matthew Roscoe

Originally from the UK, Matthew is based on the Costa Blanca and is a web reporter for The Euro Weekly News covering international and Spanish national news. Got a news story you want to share? Then get in touch at