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 submissions to request emergency use or conditional marketing authorizations for BNT162b2 in younger pediatric populations, applications for a potential booster dose and/or 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 potential submissions for younger pediatric populations, a potential booster dose or any other 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 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=5JaDr_uZVG8dk0OQV0B6UZCeL63nuowyHtC4zceFPUx2DCFrmHhCsmSfyEAfquIEZI967ffOoRKagPLCtxmp4RST2u0e9uAoHzfL5wG18MK1XOCYIZ22BUWMveBa-TLbJKO6ly7BXVn_lEXFh7KGZR839XN_JzCt87MVIjWJzNwOTr-IvpHXWsCYONLa6BekGxR7396HXJd6OrENRD9HAsU3-sZL5BrdNZnDgq5OnoSHJ865MM_oGEik-WmdFZSWiQCuY971klAkHnNE4NiNlrN0TCch5ZwUeVYEDkp-z-xtP4Gq7Qcom2qTFHWwh7mTwRbJ5QfWE6X4fL44MyEcyFVJeKG6JM-Wj_Qex9T-ksAg5q01vBJeysPbSTpE_JUmR4JVqVvnfzokKXn2lyySDhXHzHkV-pG-effZ1a2O63-KvmxyYZVrkjZ2EqVySGKJ www.sec.gov and https://www.globenewswire.com/Tracker?data=5JaDr_uZVG8dk0OQV0B6UeCrpePG0UYvLeI5p30iAJC4EXPal64vujleZv-a5v1_lVFKo_bK0iChD1HVGJVb7xpUigoisTAp85NyPv7Mo-SJU8-0B5adcGKtZ5X_3jVp6eMTEDHtis1Si9AYAiaOinpUqoyYT790SboG-ZoweC9smJQu61hj0EFjmtNggk5WupWJ7Ssp30UTg4qxd9Q2LMPQHatF7bkqDDAVatDZGus7Lw-tH834Fla-KPQ_tROPJS7A-TBr1U965qd_26H62fQohuELNdgL-6pGhVtifhT3YvIoJo6-ybbLPq1lKp2ZZT0Cg64R03fUvURrKAVxGdaB8wkyOraMpWbocVuKXfU2_ZY0P8GRz1ZUKyWWTK2TQMo8oeRv3a_HT1ylWX1iiJzTz9LcjHPS_qQI2WCfI0YNew4G7JXxEjrrc-wgWMWi 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 https://www.globenewswire.com/Tracker?data=5JaDr_uZVG8dk0OQV0B6URTd-P3hK6bpGYZb6ixkn-1L9PhgE2vAIJQsESfBssN1qtJXS6uQnjouQ6Eje_P7ZsuC6KM9nKAIKm5H0YMRlqp2-J85hdGzEZGeWUh0ZKxE9RjjfCBiRipvvcPKDkgrbS0o0bJPUYYBYyAMeDDAa2ZUlRvDBeunak83OJSzudmtFFJheVMAZCDMCXt4CaF4fNIqxE7N5IeuR_sLT9GPp1nifTLKxn7qsFcOrfLelR5y-KazuLnvXXUDxz6YZkdinDw6cg-kSqzgTF43DvHxWM8= www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including a potential booster dose and emergency use authorization in the U.S. of a booster dose for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age who have frequent institutional or occupational exposure to SARS-CoV-2; qualitative assessments of available data; potential benefits; expectations for clinical trials; the anticipated timing of regulatory submissions; regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021. 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. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at https://www.globenewswire.com/Tracker?data=5JaDr_uZVG8dk0OQV0B6Ufq__EOJfMyn_xHJ5p4qY-1C9Ttox1eQ84SUJ3rK4JH4PeeAvORIUfHb6SnWPEmlMg== 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.
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