Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. 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. “Israel’s strong health system and an unprecedented societal mobilization and awareness allowed us to achieve high national uptake of the COVID-19 vaccine in a short period of time. Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion. Findings from the analysis were derived from de-identified aggregate Israel MoH surveillance data collected between January 17 and March 6, 2021, when the Pfizer-BioNTech COVID-19 Vaccine was the only vaccine available in the country and when the more transmissible B.1.1.7 variant of SARS-CoV-2 (formerly referred to as the U.K. variant) was the dominant strain. +1 (212) 733-7410 The vaccine effectiveness estimates align with the 95% vaccine efficacy of BNT162b2 against COVID-19 demonstrated in the pivotal Randomized Clinical Trial (RCT) of BNT162b2. Thanks to our comprehensive public health surveillance program, we have been able to document the remarkable success of the nationwide vaccination campaign with the COVID-19 vaccine. Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared, Therapeutic Modalities and Technology Platforms, Small Molecule Product & Process Development, Maintaining Emotional Well-Being During COVID-19, Coronavirus disease (COVID-19) Scientific Resources, Meet our new Chief Patient Officer, Dr. Dara Richardson-Heron, Creating Cures Through Facility Investments, https://www.businesswire.com/news/home/20210311005482/en/. IgG positivity with time since single dose of Pfizer-BioNTech vaccine by age and prior COVID-19 status. 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 in vitro and Phase 3 data and the real-world evidence), 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 upon 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 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 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 a potential Biologics License Application in the U.S.) 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 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, 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; 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 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. This comprehensive real-world evidence can be of importance to countries around the world as they advance their own vaccination campaigns one year after the World Health Organization (WHO) declared COVID-19 a pandemic. Media Relations BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in Israel, the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries. Sorry, you need to enable JavaScript to visit this website. One year after the declaration of a pandemic by the WHO, we now see that we are on the right track to accomplish our goals," said Ugur Sahin, M.D., Co-Founder and CEO of BioNTech. ET by Tomi Kilgore Media Relations Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. For example, findings from the Maccabi HMO indicate that neighborhood may be an important factor. 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. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. About the Israel MoH Vaccination Program and Analysis. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Vaccine effectiveness estimates may be affected by differences between vaccinated and unvaccinated persons (i.e., different test-seeking behaviors or levels of adherence to preventive measures). JERUSALEM & NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program. 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 routinely post information that may be important to investors on our website at www.Pfizer.com. Real-time Data is provided using Nasdaq Last Sale Data Market Makers Sign up for our newsletter to get the latest on the transformative forces shaping the global economy, delivered every Thursday. [email protected]. We routinely post information that may be important to investors on our website at www.Pfizer.com. Charles.E.Triano@Pfizer.com, BioNTech: Thanks to our comprehensive public health surveillance program, we have been able to document the remarkable success of the nationwide vaccination campaign with the COVID-19 vaccine. Pfizer and BioNTech said in a joint statement the start of the review is based on data from laboratory and … Pfizer-BioNTech’s COVID-19 vaccine is an mRNA vaccine that has been shown to be highly effective in preventing symptomatic COVID-19 disease. Dramatically lower COVID-19 disease incidence rates observed in individuals fully vaccinated with the Pfizer-BioNTech vaccine, based on real-world data gathered by the Israel Ministry of Health Data suggest Pfizer-BioNTech vaccine prevents asymptomatic SARS-CoV-2 infection Latest data analysis finds unvaccinated individuals were 44 times more likely to develop symptomatic COVID-19 … (Reuters) - The European health regulator is reviewing a COVID-19 vaccine being developed by Pfizer and BioNTech <22UAy.F> in real time, days after launching a similar assessment process for AstraZeneca's vaccine. We aim to achieve even higher uptake in people of all ages, which gives us hope of regaining normal economic and social function in the not so distant future.”, “We are extremely encouraged that the real-world effectiveness data coming from Israel are confirming the high efficacy demonstrated in our Phase 3 clinical trial and showing the significant impact of the vaccine in preventing severe disease and deaths due to COVID-19,” said Luis Jodar, Ph.D., Senior Vice President & Chief Medical Officer, Pfizer Vaccines. The vaccination program started at the beginning of a large surge of SARS-CoV-2 infections in Israel, which later resulted in a national lockdown starting on January 8, 2021. However, this observational analysis differs from the RCT in several aspects. Chuck Triano On Thursday, the bloc also approved its … MoH regularly collects comprehensive, real-time data on SARS-CoV-2 testing, COVID-19 cases including date of symptom onset, and vaccination history through a nationally notifiable disease registry and the national medical record database. 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. 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 approvals or authorizations, a collaboration with the Israel MoH to monitor the real-world impact of BNT162b2 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. S&P 500 0.00%. Sylke Maas, Ph.D. These findings are also important, as the data were generated at a time when the SARS-CoV-2 variant B.1.1.7 was the dominant strain.”. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Altogether, these data are critical to understanding the role of vaccination in combatting the pandemic and provide hope to other countries dealing with this devastating disease, which has now afflicted the world for more than a year.”, “When we started our development last year in January, our aim was to make a difference for people worldwide and to help end this pandemic. Incidence rates in the fully vaccinated population have massively dropped compared to the unvaccinated population, showing a marked decline in hospitalized cases due to COVID-19,” said Professor Yeheskel Levy, Israel Ministry of Health Director. View source version on businesswire.com: https://www.businesswire.com/news/home/20210311005482/en/, Pfizer: IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com. Real-time COVID-19 vaccination updates for every region in Canada, tracking doses of Moderna, Pfizer-BioNTech and AstraZeneca COVID-19 vaccine delivered and administered to Canadians. 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 in vitro and Phase 3 data and the real-world evidence), 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 upon 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 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 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 a potential Biologics License Application in the U.S.) 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 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, 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; 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 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. The vaccine, co-developed by German partner BioNTech, is being doled out based on each state's adult population. Israel's Health Ministry, Pfizer Inc. and BioNTech SE on Thursday reported real-world evidence demonstrating dramatically lower incidence rates of … For more information, please visit www.BioNTech.de. The information contained in this release is as of March 11, 2021. +49 (0)6131 9084 1513 This means that the vaccine can greatly reduce the spread of the virus. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. Stocks: Real-time U.S. stock quotes reflect trades reported through Nasdaq only; comprehensive quotes and volume reflect trading in all markets and are delayed at least 15 minutes. Sylke Maas, Ph.D. Vaccine effectiveness was at least 97% against symptomatic COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Jasmina Alatovic In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). EU reviewing Pfizer-BioNTech Covid-19 vaccine in real time. These new data build upon and confirm previously released data from the MoH demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. The information contained in this release is as of March 11, 2021. 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. (Reuters) - Health Canada will start a real-time review of Germany's BioNTech SE and Pfizer Inc's experimental COVID-19 vaccine, the companies said on Friday. These findings are also important, as the data were generated at a time when the SARS-CoV-2 variant B.1.1.7 was the dominant strain." This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series. 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 regarding a COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date, including real-world data gathered; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on trial data of BNT162b2 in our Phase 2/3 trial; 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; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimate for 2021. About the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2). The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. 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.
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