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/Shutterstock.com

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.


Thank you for taking the time to read this article. Do remember to come back and check The Euro Weekly News website for all your up-to-date local and international news stories and remember, you can also follow us on Facebook and Instagram.

FacebookTwitterRedditWhatsAppTelegramLinkedInEmailCopy Link
Go Back
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 [email protected]

Comments


    • Naimah Yianni

      22 August 2022 • 18:14

      There clearly is no emergency (not that ever was) so how can they ask for emergency authorisation? Ridiculous. Just adding to the billions that they have already made from their concoctions

      Reply
    • M

      23 August 2022 • 12:05

      Readers are shown clearly that there is NO health emergency, and that this request is simply to circumvent applying through the legal route of applying for a genuine license which would require years of trial safety data to be made available ( which they don’t have!). We have seen the aftermath of injections given to people under so called emergency powers with the UK Government now having to pay compensation to people who have been killed or disabled through such a policy. Please be very wary of these companies and their stoodges who push such an agenda with any critism of this been constantly suppressed.

      Reply
    • CCW60

      23 August 2022 • 21:34

      Emergency? What EMERGENCY?! This is nothing more than criminals at Pfizer trying to rake in more money off their death jabs. Hopefully people are waking up and will refuse to submit to any further experimental gene therapy drugs!

      Reply

    Leave a comment

    Your email address will not be published.