By Matthew Roscoe • Published: 22 Aug 2022 • 17:49
Pfizer/BioNTech request "emergency use" authorisation from FDA for Omicron-specific jab. Image: Ververidis Vasilis/Shutterstock.com
“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.”
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. — TheElder ⚑ (@PlanZip) August 22, 2022
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.
— TheElder ⚑ (@PlanZip) August 22, 2022
“They still going on about it? Already made billions,” said another.
They still going on about it? Already made billions — Bhimashish (@aashu309) August 22, 2022
They still going on about it? Already made billions
— Bhimashish (@aashu309) August 22, 2022
“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.
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 — OhMeh (@CAEZMEH) August 22, 2022
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
— OhMeh (@CAEZMEH) August 22, 2022
While another person said: “What’s Your Emergency 🤔”
What's Your Emergency 🤔 https://t.co/xX0UeVnqM4 — 🥳Caro🌿lyn🌿💖🌸🕊🌺🐝🌻🦋 (@carolyn2813928) August 22, 2022
What's Your Emergency 🤔 https://t.co/xX0UeVnqM4
— 🥳Caro🌿lyn🌿💖🌸🕊🌺🐝🌻🦋 (@carolyn2813928) August 22, 2022
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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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 editorial@euroweeklynews.com.
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
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.
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!
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