Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age

Germany–( BUSINESS WIRE)– PfizerInc.( NYSE PFE) and BioNTech SE( Nasdaq BNTX) moment blazoned that theU.S. Food and Drug Administration( FDA) granted exigency Use Authorization( EUA) for a 10- µg supporter cure of their OmicronBA.4/BA.5- acclimated bivalent COVID- 19 vaccine in children 5 through 11 times of age. Pending recommendation from the Centers for Disease Control and Prevention( CDC), 10- µg boluses will be packed incontinently.
“ As families across the country take part in fall fests and plan for the forthcoming vacation season, we aim to give academy-aged children with fresh protection against the OmicronBA.4/BA.5 subvariants, which continue to regard for further than 80 of cases in theU.S., ” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “ Anticipating this need, we manufactured millions of supporter boluses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID- 19 vaccinations. ”

“ This corner is important to be suitable to give access to variant- acclimated vaccines to a broader population, ” saidProf. Ugur Sahin,M.D., CEO andCo-founder of BioNTech. “ In addition, we’ve started a clinical trial to estimate the acclimated vaccine grounded on theBA.4 andBA.5 subvariants in children six months through 11 times of age aiming to offer all age groups the occasion to immunize against Omicron variants and subvariants. ”

The authorization of the bivalent COVID- 19 vaccine for children 5 through 11 times of age is supported by safety and immunogenicity data from Pfizer and BioNTech’s 30- µg OmicronBA.1- acclimated bivalent vaccine,non-clinical and manufacturing data from the companies ’ 10- µg OmicronBA.4/BA.5- acclimated bivalent vaccine, andpre-clinical data from the 30- µg OmicronBA.4/BA.5- acclimated bivalent vaccine. Clinical data from a Phase2/3 trial showed a supporter cure of Pfizer and BioNTech’s 30- µg OmicronBA.1- acclimated bivalent vaccine inspired a superior vulnerable response against the OmicronBA.1 subvariant compared to the companies ’ original COVID- 19 vaccine, with a favorable safety profile. also,pre-clinical data showed a supporter cure of the 30- µgBA.4/BA.5- acclimated bivalent vaccine generated a strong neutralizing antibody response against the OmicronBA.1,BA.2,BA.4 andBA.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 5 through 11 times of age are anticipated to start subject to and after the CDC endorses a implicit recommendation. 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.

Pfizer and BioNTech have submitted an operation to the European Medicines Agency( EMA) requesting a variation of the companies ’ selling authorization in the European Union to include a 10- µg supporter cure of OmicronBA.4/BA.5- acclimated bivalent COVID- 19 vaccine in this age group. analogous operations are planned for submission with nonsupervisory authorities around the world in the coming weeks.

A Phase 1/2/3 pediatric study is presently underway to estimate different dosing rules and cure situations of the OmicronBA.4/BA.5- acclimated bivalent COVID- 19 vaccine across age groups.

The Pfizer- BioNTech COVID- 19 Vaccine, which is grounded on BioNTech’s personal mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2( COMIRNATY ®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of exigency use authorizations or coequals in the United States( concertedly with Pfizer) and other countries. cessions to pursue nonsupervisory blessings in those countries where exigency use authorizations or original were originally granted are planned.
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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