Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialization of the vaccine. In March, the drugmakers said the vaccine was found to be safe, … BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. Pfizer and BioNTech to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and … About BioNTechBiopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer, infectious diseases and rare diseases. Media Relations BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. About Pfizer: Breakthroughs That Change Patients’ LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. The stunning results vaulted BioNTech and Pfizer to the front of the race to find a cure for a disease that has killed more than 1.2 million people worldwide. Companies will jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection Collaboration aims to accelerate global development of BNT162, leveraging expertise and resources of both companies Builds on 2018 agreement to jointly develop an mRNA-based influenza vaccine Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech… Its broad portfolio of product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. [email protected] Media RelationsAmy Rose (U.S.)+1 (212) 733-7410amy.rose@pfizer.com, Lisa O’Neill (UK)+44 7929339560 lisa.o'neill@pfizer.com, Investor RelationsRyan Crowe+1 (212) 733-8160ryan.crowe@pfizer.com, Media RelationsJasmina Alatovic Senior Manager Global External Communications+49 (0)6131 9084 1513 or +49 (0)151 1978 1385Media@biontech.de, Investor RelationsSylke Maas, Ph.D.VP Investor Relations & Business Strategy+49 (0)6131 9084 1074Investors@biontech.de, BioNTech SE The Pfizer-BioNTech vaccine received authorization for use by the UK regulator on 2 December. Ryan Crowe BioNTech Forward-looking statementsThis press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network. lisa.o'[email protected] At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Sorry, you need to enable JavaScript to visit this website. In after-hours action, Pfizer gained 2.4% to 42.75 while BioNTech added 1.9% to 131.99. This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, BioNTech’s mRNA vaccine program, BNT162, a collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine and manufacturing capacity, including their potential benefits, and the expected timing of clinical trials and potential supply, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. 2020;160:223-232. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. The Pfizer-BioNTech COVID-19 vaccine is administered as an intramuscular injection on day 0 and again on day 21. Sylke Maas, Ph.D. “Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. Safety over a median of 2 months was similar to that of other viral vaccines. Baum, A. et al. The products discussed herein may have different labeling in different countries. He claimed that the speed with which British regulators appraised trial evidence on the Pfizer-BioNTech … BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), and Pfizer Inc. (NYSE: PFE) today disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020. ... et al. BioNTech and Pfizer announce regulatory approval from … “Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. For more than 150 years, we have worked to make a difference for all who rely on us. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. Jul. These forward-looking statements may include, but may not be limited to, BioNTech’s efforts to combat COVID-19, the ability of BioNTech and Pfizer to co-develop and co-commercialize a vaccine for COVID-19, the ability of BioNTech and Pfizer to develop manufacturing capacity, BioNTech’s potential COVID-19 mRNA vaccine, BNT162, an agreement regarding the co-development and co-commercialization by Pfizer and BioNTech of BNT162, including its potential benefits and the expected timing of a Phase 1 trial of BNT162. The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. These risks and uncertainties include, but are not limited to: competition to create a vaccine for Covid-19 and potential difficulties. Pfizer Inc and its German partner BioNTech SE on Friday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15. For more information, please visit www.BioNTech.de. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network. Lisa O’Neill (UK) Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic Pfizer and BioNTech began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion … A case control study, which has been peer reviewed and published in the New England Journal of Medicine , compared 596 618 people who were newly vaccinated in … handling or other issues:service@biontech.de, For any other questions, please Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer, infectious diseases and rare diseases. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. This press release features multimedia. US company Moderna has also developed an RNA vaccine, which has also been approved for use in the United States. An der Goldgrube 12 Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialization of the vaccine. “I am proud of Pfizer’s collaboration with BioNTech and have every confidence in our ability to harness the power of science – together – to bring forth a potential vaccine that the world needs as quickly as possible.”. Amy Rose (U.S.) During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. This webinar provide an overview and education of the Pfizer-BioNTech COVID19 vaccine. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval. These risks and uncertainties include, but are not limited to: competition to create a vaccine for Covid-19 and potential difficulties. The company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. MAINZ, Germany & NEW YORK--(BUSINESS WIRE)-- BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. In Europe, Pfizer and BioNTech initially shipped vials of five-vaccine doses, but because of a precautionary practice known as overfilling, the vials contained enough extra liquid for a sixth dose. use our contact form atconnect.biontech.de, We aspire to utilize the full potential of the immune system to fight cancer and infectious diseases, Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development, Our vision: individualize cancer medicine, How we approach individualized cancer medicine, Why mRNA represents a disruptive new drug class, Beyond mRNA: Expanding therapeutics with our antibody discovery engines, Explore our individualized immunotherapy pipeline, Tour our platforms that produce individually-tailored therapeutics, Our Mission: broaden the therapeutic universe to benefit patients. A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. NACCHO invites local health department leadership and staff to join the Pfizer-BioNTech COVID-19 Vaccine Training & Education webinar on Tuesday, January 12, 3:00-4:00 pm ET.. CAS PubMed Google Scholar Under the terms of the agreement, Pfizer will pay BioNTech $185 million in upfront payments, including a cash payment of $72 million and an equity investment of $113 million. [email protected] The company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. View source version on businesswire.com: https://www.businesswire.com/news/home/20200409005405/en/, Pfizer Contacts “We have already started working with Pfizer on our COVID-19 vaccine and are pleased to announce these further details of our ongoing collaboration, which reflects both companies’ strong commitment to move quickly to bring a safe and efficacious vaccine to patients worldwide,” says Co-Founder and CEO of BioNTech, Ugur Sahin, M.D. Pfizer and BioNTech will share development costs equally. For more than 150 years, we have worked to make a difference for all who rely on us. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Its broad portfolio of product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. This vaccine is not a live virus vaccine and can be given to immunocompromised patients, including patients on immunosuppressant … Pfizer Disclosure NoticeThe information contained in this release is as of April 9, 2020. +1 (212) 733-8160 Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies. ET Germany, For questions on logistics, Boris Johnson warns of ‘immense logistical challenge,’ as U.K. becomes first to authorize use of Pfizer–BioNTech COVID-19 vaccine Published: Dec. 4, 2020 at 3:03 p.m. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. ). But Dr. Sahin’s pivot to Covid-19 in January scrambled the timetable. Pfizer and BioNTech will share development costs equally. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.