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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. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. 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. View the full release here: https://www.businesswire.com/news/home/20200409005405/en/. 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. The company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. 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. 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. Senior Manager Global External Communications 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. “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. 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. “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.”. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any biologics license applications may be filed in any jurisdictions for any potential vaccine candidates under the collaboration; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such vaccine candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities regarding any such vaccine candidates and uncertainties regarding the commercial impact of any such recommendations; and competitive developments. 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. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. 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.. NEW YORK, USA a MAINZ, Nemecko, 17. marec 2020 – Spoločnosti Pfizer Inc. a BioNTech SE dnes oznámili, že podpísali dohodu ohľadom spoločného vývoja a distribúcie (s výnimkou Číny) prípadnej vakcíny proti koronavírusu na báze mRNA určenej na prevenciu infekcie COVID-19. +1 (212) 733-7410 [email protected] 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. Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer, infectious diseases and rare diseases. Pfizer/BioNTech COVID-19 vaccine candidate shows encouraging action in preclinical studies. 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. For more than 150 years, we have worked to make a difference for all who rely on us. 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. 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. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance. Safety over a median of 2 months was similar to that of other viral vaccines. Ryan Crowe In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network. EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age.EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine … ... April 9, 2021, 7:09 p.m. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. ). In after-hours action, Pfizer gained 2.4% to 42.75 while BioNTech added 1.9% to 131.99. 2020;160:223-232. This information—including product information—is intended only for residents of the United States. The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. “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 are readying “Mission Possible,” a branded content film created in collaboration with National Geographic, for debut on March 11. 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. 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. For a discussion of these and other risks and uncertainties, see the section entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020 which has been filed with the SEC and is available on the SEC’s website at www.sec.gov. handling or other issues:service@biontech.de, For any other questions, please The Pfizer-BioNTech COVID-19 vaccine is administered as an intramuscular injection on day 0 and again on day 21. Baum, A. et al. He claimed that the speed with which British regulators appraised trial evidence on the Pfizer-BioNTech … Copyright © 2002-2021 Pfizer Inc. All rights reserved. Science 369 , 1014–1018 (2020). 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. Spoločnosti uzavreli dohodu o … BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. For more than 150 years, we have worked to make a difference for all who rely on us. Pfizer and BioNTech will share development costs equally. Germany, For questions on logistics, The manufacturer’s information for healthcare professionals contains no information on interactions with any other medication (since this has not been studied). 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. 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. BioNTech and Pfizer announce regulatory approval from … 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 We routinely post information that may be important to investors on our website at www.Pfizer.com. 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. But Dr. Sahin’s pivot to Covid-19 in January scrambled the timetable. Sorry, you need to enable JavaScript to visit this website. For a discussion of these and other risks and uncertainties, see the section entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020 which has been filed with the SEC and is available on the SEC’s website at www.sec.gov. ET. For more information, please visit www.BioNTech.de. and BioNTech for the purchase of up to 1.8 billion doses of their COVID-19 vaccines to be delivered in 2022 and 2023, an EU official told Reuters. “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. Investor Relations Media Relations The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. lisa.o'[email protected] View source version on businesswire.com: https://www.businesswire.com/news/home/20200409005405/en/, Pfizer Contacts [email protected] The Pfizer BioNTech coronavirus vaccine produces as good results in the “real world” as have been previously documented in randomised trials. “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.”. 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. 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. 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 … 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. “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. The full benefit from the vaccine occurs 2 weeks after the second injection. 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. The joint vaccine, produced by American pharmaceutical giant Pfizer and German biotech firm BioNTech, had recently claimed to be 94 per cent effective in protecting people over 65 years old from COVID-19, with trials suggesting it works equally well in people of all ages, races and ethnicities. An der Goldgrube 12 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 Sylke Maas, Ph.D. VP Investor Relations & Business Strategy All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. Pfizer/BioNTech COVID-19 vaccine candidate shows encouraging action in early-stage study. CAS PubMed Google Scholar 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. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance.

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