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Pfizer and BioNTech Publish Results of Study Showing COVID-19 Vaccine Elicits Antibodies that Neutralize Pseudovirus Bearing the SARS-CoV-2 U.K. Strain Spike Protein in Cell CultureNew York and Mainz, Germany, January 20, 2021 — Today, Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage or VOC 202012/01. The results were published on the preprint server bioRxiv and submitted to a peer-reviewed journal. The B.1.1.7 lineage is a rapidly spreading variant of SARS-CoV-2 initially detected in the United Kingdom that carries a larger than usual number of genetic changes with 10 mutations located in the spike protein. BioNTech and Pfizer have previously published data from an in vitro study that evaluated one of the key mutations (N501Y) in the U.K. strain, which is also shared by the South African strain. That study showed efficient neutralization of the N501Y mutated spike bearing virus by sera of individuals who had received the Pfizer-BioNTech COVID-19 vaccine. The current in-vitro study investigated the full set of UK strain spike mutations. To this aim, a pseudovirus featuring the UK strain spike protein was generated. The pseudovirus recapitulates SARS-CoV-2 virus binding and cell entry. Sera of participants from the previously reported German Phase 1/2 trial inhibited pseudovirus bearing the U.K. strain SARS-CoV-2 spike in a neutralization range that is regarded as biologically equivalent to the unmutated Wuhan SARS-CoV-2 spike. While the pseudovirus system used is a surrogate for authentic SARS-CoV-2, previous studies have shown excellent concordance between pseudotype neutralization and SARS-CoV-2 neutralization assays.i The preserved neutralization of the pseudovirus bearing the U.K. strain spike by BNT162b2-immune sera makes it likely that COVID-19 caused by the UK virus variant will also be prevented by immunization with BNT162b2. Pfizer and BioNTech are encouraged by these early in vitro study findings. Further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. So far, for COVID-19 vaccines it has not been established what reduction in neutralization might indicate the need for a vaccine strain change. Should a vaccine strain change be required to address virus variants in the future, the Companies believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to enable such adjustment. AUTHORIZED USE IN THE U.S.: IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:
About Pfizer: Breakthroughs That Change Patients’ Lives Pfizer Disclosure Notice 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, the anticipated timing of regulatory submissions, regulatory approval or authorization 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 clinical data (including the in vitro and Phase 3 data), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial 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 upon commercialization; the ability of BNT162b2 to prevent COVID-19 caused by new 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 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; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines; whether and when any other applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S.) 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, 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 or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to handling after delivery by Pfizer; the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have 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 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; 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, 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. About BioNTech BioNTech Forward-looking statements For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, 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. Pfizer: Media Relations Investor Relations BioNTech: Media Relations Investor Relations iJ. B. Case et al., Neutralizing Antibody and Soluble ACE2 Inhibition of a Replication-Competent VSV-SARS-CoV-2 and a Clinical Isolate of SARS-CoV-2. Cell host & microbe. 28, 475-485.e5 (2020) A. B. Vogel et al., BNT162b vaccines are immunogenic and protect non-human primates against SARS-CoV-2. bioRxiv (2020)
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