At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve 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 medicines and vaccines. 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. 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. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at https://www.globenewswire.com/Tracker?data=GOo_P27dx6eV4DMUMn_usTpNC7aiwBGyS-rTzR79Qu8bfEMYfoEDuHe7s_xZeHzKYPJXoXQ921247COlqL7jBQ== www.Pfizer.com. In addition, to learn more, please visit us on https://www.globenewswire.com/Tracker?data=GOo_P27dx6eV4DMUMn_usUa0BKtEMWPtQ0bzUJ7tSZuQbmqSIDXeC1Or3vDaDkY8RHwDS9tMOYDoYoQae4c00w== www.Pfizer.com and follow us on Twitter at https://www.globenewswire.com/Tracker?data=vSIKkzWEuyVreLdFel8T0ocQ0Va_1GaCVmSLg6h6wm-m4NF5A4lZ1WvjBIx3hNsZU0TY3kd_AkQ_AY7fa001Bg== @Pfizer and https://www.globenewswire.com/Tracker?data=vSIKkzWEuyVreLdFel8T0lUHxekNbXGMvr5qOrGLQxE2xkEQN1bFn-Xc9gHHlDD4zufTArGoV_p-hHdUPROk9wn1iV_Hj4kOqknP1gYbUII= @Pfizer News, https://www.globenewswire.com/Tracker?data=TNtOazALVHUuHDq7ctqdnEwn2jrd7FQSS0g76ComDhePgqTeIzrto0WAWOhBzDB90Rc0mnfRXMy-JyIzm-JM1KpCIIeyRl1zMvdRfnBsbAw= LinkedIn, https://www.globenewswire.com/Tracker?data=fbDC_yNFPVEX3eeEekzhqSmHvBAzbAPq3xTj0N8Jp0a9Y-gRSoV1yoN6O90k1bjbaYzqKbsM980ygta71vCCSw== YouTube and like us on Facebook at https://www.globenewswire.com/Tracker?data=1F-46qiVe8OY6dnwEj1hE9a5ducsPeCuf52KPxLRcS0YExYeOrhOnFpuzUij4Hj5PNcKTgeg2W2K8hP_APXEy-d2QSCNiNyGAggn_MdHi6g= Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of July 23, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, supply to the U.S. government and the timing of delivery of doses thereunder, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. 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 preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and 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 additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, 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; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.
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, 2020 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 https://www.globenewswire.com/Tracker?data=GOo_P27dx6eV4DMUMn_usXCmCDgZQJtKXvKYH3xKn8UWRvs66jtaZTVeQcmfFVkRz0GgC1d4RYrpVeoAWmsavBA6fYQXQZGl3iDmMH7OGZY9AVJ1Uzf1RK_CLdKTOIcnuGTIsucIEe_gE5nIcVg-GBgUB-8ANbD8RhtALvGsBiknVTqe2yslRcxg2XQhK93tbfyDv9ke24Ceh03H7oPLzrFLJ0S_eJdfHsXJIjiM0-g= www.sec.gov and https://www.globenewswire.com/Tracker?data=GOo_P27dx6eV4DMUMn_uscWlFrLlJf9UVwstSTDNRq9PuM0ELWr-sisE_K8U8Qm3uEU4VIPaWNOLIpMMcj0bM2ypybJ6oOUoaPmDDx0OcnIy30HLnRn0hNKHwdv1n5a9YEi85FkoEemypCNhYJ4OoviKG4OrUebKK8VK-hsyUcMSzrjAb82922M0VYtNCHPqM3sEtOYUyB9pJ7LedwqaORGT6jXIDaFUnOLlhpFBs3E= www.pfizer.com.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. 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. 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. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements
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July 23, 2021 06:45 ET (10:45 GMT)