Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union

  • CHMP recommendation based on favorable data from Omicron-adapted vaccines
  • The Omicron BA.4/BA.5 bivalent COVID-19 booster vaccine combines 15-ug of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccines and 15-ug of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants
  • Pfizer-BioNTech bivalent Omicron BA.4/BA.5 COVID-19 vaccine is available to ship immediately, pending European Commission approval, to support EU vaccination campaigns this fall

PfizerInc.( NYSE PFE) and BioNTech SE( Nasdaq BNTX) moment blazoned a 30- µg supporter cure of their OmicronBA.4/BA.5 bivalent- acclimated COVID- 19 Vaccine( COMIRNATY ® Original/ OmicronBA.4/BA.515/15 µg) has been recommended for tentative marketing authorization( cMA) by the European Medicines Agency’s( EMA) Committee for Medicinal Products for Human Use( CHMP) for individualities periods 12 times and aged. The European Commission will review the CHMP recommendation and is anticipated to make a final decision soon.
The OmicronBA.4/BA.5- acclimated bivalent vaccine contains 15- µg of mRNA garbling the wild- type shaft protein of SARS- CoV- 2 in the Original Pfizer- BioNTech COVID- 19 Vaccine, and 15- µg of mRNA garbling the shaft protein of the OmicronBA.4/BA.5 subvariants. piecemeal from the addition of the mRNA sequence of theBA.4/BA.5 shaft protein, all other factors of the vaccine remain unchanged.

“ This recommendation marks another major corner in the ongoing global fight against COVID- 19, bolstering our defenses as we prepare for fall and downtime with implicit increased exposure to the contagion, ” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “ Due to our multifaceted approach helping to address arising variants and subvariants of concern, public health authorities in the EU will have our bivalent supporter options, pending authorization, to grease flexible vaccination strategies for minimal content across the region. ”

still, EU residers will have access to Omicron- acclimated vaccines before the launch of the downtime season, ” said Prof, “ If the European Commission follows moment’s recommendation by the CHMP. Ugur Sahin,M.D., CEO andCo-founder of BioNTech. “ The bivalent vaccines render the shaft protein of the SARS- CoV- 2 wild- type as well as a shaft protein of an Omicron subvariant. They aim to give broader immunization against COVID- 19 caused by the current dominant Omicron sublineages and former variants of concern. ”

moment’s recommendation follows guidance from the EMA, World Health Organization( WHO) and International Coalition of Medicines Regulatory Authorities( ICMRA) to advance bivalent vaccine campaigners, with the thing of making an Omicron- acclimated vaccine available to European Union( EU) member countries as soon as possible. The CHMP recommendation concerning the OmicronBA.4/BA.5 bivalent COVID- 19 vaccine is grounded on data from Pfizer’s and BioNTech’s OmicronBA.1- acclimated bivalent vaccine as well aspre-clinical and manufacturing data from the OmicronBA.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 OmicronBA.1 subvariant compared to the companies ’ current COVID- 19 vaccine, with a favorable safety profile. also,pre-clinical data showed a supporter cure of theBA.4/BA.5- acclimated bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages includingBA.1,BA.2,BA.4 andBA.5 subvariants, as well as the original contagion, while retaining a favorable safety profile.

still, the Pfizer- BioNTech bivalent Omicron BA, If an authorization is granted.4/BA.5 COVID- 19 vaccine will be available within the coming days to all 27 EU member states supporting the European vaccination juggernauts. Original force may vary grounded on individual country government requests. In early September, Pfizer and BioNTech were granted a tentative marketing authorization for an OmicronBA.1- acclimated bivalent COVID- 19 vaccine in the EU. An Omicron- acclimated vaccine grounded on theBA.4/BA.5 subvariant was also authorized by theU.S. Food and Drug Administration as a supporter for periods 12 and aged on August 31, 2022. The companies are also planning to file the data with other nonsupervisory authorities in the coming weeks and are planning to submit data to the FDA and the EMA to prepare an operation for an Omicron- acclimated bivalent vaccine in children youngish than 12 times of age.

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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