Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older

  • Authorization based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines
  • Pfizer-BioNTech Omicron BA.4/BA.5 Bivalent Vaccine combines 15-µg of mRNA encoding the wild-type spike protein found in the Original Pfizer-BioNTech COVID-19 Vaccine and 15-µg of mRNA encoding the spike protein of the OmicronBA.4/BA.5 subvariants
  • Pfizer-BioNTech Omicron BA.4/BA.5 COVID-19 Bivalent Vaccine available to ship immediately

PfizerInc.( NYSE PFE) and BioNTech SE( Nasdaq BNTX) moment blazoned that theU.S. Food and Drug Administration( FDA) granted exigency Use Authorization( EUA) of a 30- µg supporter cure of the Pfizer- BioNTech COVID- 19 Vaccine, Bivalent( Original( 15 µg) and Omicron BA.4/ BA.5( 15 µg)) for individualities periods 12 times and aged. An operation for an Omicron- acclimated bivalent vaccine for children 5 through 11 times of age is planned for submission to FDA in early October. The companies are working with the FDA to prepare an operation for an Omicron- acclimated bivalent vaccine in children 6 months through 4 times of age.

The Omicron BA.4 and BA.5 subvariants together are the current variants of concern in theU.S., egging the FDA to instruct manufacturers to develop a variant- acclimated vaccine that also addresses the shaft protein of the Omicron BA.4/ BA.5 subvariants. Pfizer and BioNTech’s bivalent vaccine contains 15- µg of mRNA garbling the wild- type shaft protein of SARS- CoV- 2, which is present in the Original Pfizer- BioNTech COVID- 19 Vaccine, and 15- µg of mRNA garbling the shaft protein of the Omicron BA.4/ BA.5 subvariants. Because the Omicron BA.4 and BA.5 subvariants contain identical shaft protein amino acid sequences, both can be targeted at formerly with a single mRNA beachfront. piecemeal from the addition of the mRNA sequence of the Omicron BA.4/ BA.5 shaft protein, all other factors of the vaccine remain unchanged.

“ As we head into the fall and downtime season, with the eventuality for lesser SARS- CoV- 2 spread in seminaries and at work, it’s important to stay up to date with vaccines as a first line of defense against COVID- 19 illness, ” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “ We’re thrilled by moment’s news, another important corner in our ongoing sweats to give protection against this contagion. ”

“ With moment’s blessing, a vaccine will shortly come available that addresses the presently current Omicron sublineages with the end of conserving protection against COVID- 19, ” saidProf. Ugur Sahin,M.D., CEO andCo-founder of BioNTech. “ In lower than three months, we were suitable to develop and manufacture an Omicron BA.4/BA.5- acclimated vaccine. This corner further underlines the strength of fleetly adaptable mRNA vaccines against the this continuously evolving contagion. ”

The authorization of the bivalent COVID- 19 vaccine is grounded on clinical data from Pfizer and BioNTech’s OmicronBA.1- acclimated bivalent vaccine as well aspre-clinical and manufacturing data from their Omicron BA.4/BA.5- acclimated bivalent vaccine. Clinical data from a Phase2/3 trial showed a supporter cure of Pfizer and BioNTech’s OmicronBA.1- acclimated bivalent vaccine inspired a superior vulnerable response against the Omicron BA.1 subvariant compared to the companies ’ current COVID- 19 vaccine, with a favorable safety profile. also,pre-clinical data showed a supporter cure of the BA.4/BA.5- acclimated bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original contagion.

The companies will supply the original and bivalent vaccines under their being force agreement with theU.S. government. supporter vaccinations for individualities 12 times of age and aged are anticipated to start subject to and after the Centers for Disease Control and Prevention( CDC) plump a implicit recommendation by the Advisory Committee on Immunization Practices( ACIP). Pfizer and BioNTech will begin dispatching bivalent boluses as directed by theU.S. government. EligibleU.S. residers will continue to admit the vaccine for free, harmonious with theU.S. government’s commitment to free access to COVID- 19 vaccines.

About Pfizer improvements That Change Cases ’ Lives

At Pfizer, we apply wisdom and our global coffers to bring curatives to people that extend and significantly ameliorate their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative drugs and vaccines. Every day, Pfizer associates work across developed and arising requests to advance heartiness, forestallment, treatments and cures that challenge the most stressed conditions of our time. harmonious with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we unite with health care providers, governments and original communities to support and expand access to dependable, affordable health care around the world. For further than 170 times, we’ve worked to make a difference for all who calculate on us.
About BioNTech

Biopharmaceutical New Technologies is a coming generation immunotherapy company introducing new curatives for cancer and other serious conditions. The Company exploits a wide array of computational discovery and remedial medicine platforms for the rapid-fire development of new biopharmaceuticals. Its broad portfolio of oncology product campaigners includes personalized and off- the- shelf mRNA- grounded curatives, innovative fantastic antigen receptor T cells, bispecific vulnerable checkpoint modulators, targeted cancer antibodies and small motes. Grounded on its deep moxie in mRNA vaccine development and in- house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine campaigners for a range of contagious conditions alongside its different oncology channel. BioNTech has established a broad set of connections with multiple global medicinal collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

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