For more information, please visit www.BioNTech.de. The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. ET Damit Verizon Media und unsere Partner Ihre personenbezogenen Daten verarbeiten können, wählen Sie bitte 'Ich stimme zu.'
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. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making. The vaccine development program is evaluating at least four experimental vaccine candidates, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen.
Its broad portfolio of oncology 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. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Pfizer Disclosure NoticeThe information contained in this release is as of July 31, 2020.
© 2020 GlobeNewswire, Inc. All Rights Reserved. For more than 150 years, we have worked to make a difference for all who rely on us. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC’s website at www.sec.gov. 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. 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. Information about your device and internet connection, including your IP address, Browsing and search activity while using Verizon Media websites and apps. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the timing to initiate clinical trials of BNT162 and anticipated publication of data from these clinical trials; the timing for any potential emergency use authorizations or approvals; the potential to enter into additional supply agreements with other jurisdictions or the COVAX Facility; the potential safety and efficacy of BNT162; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. “In bringing the world together at one place, for centuries, the Olympic Games have been a symbol of a global community.
BioNTech Forward-looking StatementsThis press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995.
Pfizer Inc. is a research-based, global biopharmaceutical company. On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study. aus oder wählen Sie 'Einstellungen verwalten', um weitere Informationen zu erhalten und eine Auswahl zu treffen. Media RelationsAmy Rose+1 (212) 733-7410Amy.Rose@pfizer.com, Investor RelationsChuck Triano+1 (212) 733-3901Charles.E.Triano@Pfizer.com, Media RelationsJasmina Alatovic+49 (0)6131 9084 1513 or +49 (0)151 1978 1385Media@biontech.de, Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074Investors@biontech.de, 190705_Biontech_Logo_RGB_Dark Green (Preferred)_0.png. We are proud and honored that our vaccine candidate may contribute to the efforts undertaken by the government of Japan to turn this vision into reality,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. NEW YORK and MAINZ, Germany, July 31, 2020 (GLOBE NEWSWIRE) -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, beginning in 2021. Dies geschieht in Ihren Datenschutzeinstellungen.
“We are deeply honored to work with the Japanese government and to marshal our scientific and manufacturing resources toward our shared goal of bringing millions of doses of a potential COVID-19 vaccine to the Japanese people as quickly as possible,” said Albert Bourla, Chairman and CEO, Pfizer. Any forward-looking statements in this press release are based on BioNTech 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. In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world. 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 risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data that may be inconsistent with the data used for selection of the BNT162b2 vaccine candidate and dose level for the Phase 2/3 study; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; 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 vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it 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 a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.
Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Recently, two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA). The following is a list of subsidiaries of the Company as of December 31, 2011, omitting some subsidiaries which, considered in the aggregate, would not constitute a significant subsidiary. In the late-stage trial, the companies will study a 30µg dose level in a 2-dose-regimen among up to 30,000 participants aged 18 – 85 years.
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