Media Relations Investors@biontech.de. (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. Chuck Triano [email protected], Investor Relations +49 (0)6131 9084 1513 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. Quotes displayed in real-time or delayed by at least 15 minutes. Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at, Vaccination providers should review the Fact Sheet for. 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 www.sec.gov and www.pfizer.com. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. However, this analysis was not able to evaluate vaccine effectiveness against B.1.351 (formerly referred to as the South African variant) due to the limited number of infections caused by this strain in Israel at the time the analysis was conducted. 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%). View source version on businesswire.com: https://www.businesswire.com/news/home/20210311005482/en/, Pfizer: +1 (212) 733-7410 “The findings which suggest that the vaccine may also provide protection against asymptomatic SARS-CoV-2 infections are particularly meaningful as we look to disrupt the spread of the virus around the globe. 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. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. “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. 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. About Pfizer: Breakthroughs That Change Patients’ Lives. Real-time trade and investing ideas on BioNTech BNTX from the largest community of traders and investors. Vaccine effectiveness estimates – adjusted to account for variances in age, gender and the week specimens were collected – were determined for the prevention of six laboratory-confirmed SARS-CoV-2 outcomes comparing unvaccinated and fully-vaccinated individuals: SARS-CoV-2 infections (includes symptomatic and asymptomatic infections); asymptomatic SARS-CoV-2 infections; COVID-19 cases (symptomatic only); COVID-19 hospitalizations; severe (respiratory distress, including >30 breaths per minute, oxygen saturation on room air <94%, and/or ratio of arterial partial pressure of oxygen to fraction of inspired oxygen <300mm mercury) and critical (mechanical ventilation, shock, and/or heart, liver or kidney failure) COVID-19 hospitalizations; and COVID-19 deaths. 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. 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. The vaccine has now been granted a conditional marketing authorization, emergency use authorization or temporary authorization in a total of more than 60 countries. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. For more information, please visit www.BioNTech.de. 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.”. Despite efforts to adjust for these effects in the available dataset, the possibility remains of unmeasured distortions. Sylke Maas, Ph.D. EU reviewing Pfizer-BioNTech Covid-19 vaccine in real time. This approach should help to identify the most promising candidate to evaluate in a greater number of volunteers, if it shows enough potential, and in a manner that will facilitate the sharing of data with regulatory authorities in real time. [email protected]. About Pfizer: Breakthroughs That Change Patients’ Lives. 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. Following the authorization for emergency use of the Pfizer-BioNTech COVID-19 Vaccine in Israel on December 6, 2020, the Israel MoH launched a national vaccination program targeting individuals age 16 years or older – a total of 6.4 million people, representing 71% of the population. In the RCT, randomization minimized the impact of differences between vaccinated and unvaccinated. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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. Our vaccine has been effective in preventing COVID-19 cases, as well as profoundly reducing the rate of COVID-19 related severe diseases, hospitalizations and deaths. 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 Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. 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. Charles.E.Triano@Pfizer.com, BioNTech: JERUSALEM & NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech (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 … The vaccine, co-developed by German partner BioNTech, is being doled out based on each state's adult population. 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. 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. 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. We routinely post information that may be important to investors on our website at www.Pfizer.com. S&P 500 0.00%. Vaccine effectiveness estimates – adjusted to account for variances in age, gender and the week specimens were collected – were determined for the prevention of six laboratory-confirmed SARS-CoV-2 outcomes comparing unvaccinated and fully-vaccinated individuals: SARS-CoV-2 infections (includes symptomatic and asymptomatic infections); asymptomatic SARS-CoV-2 infections; COVID-19 cases (symptomatic only); COVID-19 hospitalizations; severe (respiratory distress, including >30 breaths per minute, oxygen saturation on room air <94%, and/or ratio of arterial partial pressure of oxygen to fraction of inspired oxygen <300mm mercury) and critical (mechanical ventilation, shock, and/or heart, liver or kidney failure) COVID-19 hospitalizations; and COVID-19 deaths. The MoH analysis was conducted when more than 80% of tested specimens in Israel were variant B.1.1.7, providing real-world evidence of the effectiveness of BNT162b2 for prevention of COVID-19 infections, hospitalizations, and deaths due to variant B.1.1.7. 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. 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. Lower panels show counts of vaccines … +1 (212) 733-7410 Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine. For more information, please visit www.BioNTech.de. 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. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. Further vaccine effectiveness analyses investigating the effect of additional covariates such as location, comorbidities, race/ethnicity, and likelihood of seeking SARS-CoV-2 testing are warranted. +1 (212) 733-3901 “This clearly demonstrates the power of the COVID-19 vaccine to fight this virus and encourages us to continue even more intensively with our vaccination campaign. This MoH analysis uses de-identified aggregate Israel MoH public health surveillance data from January 17 through March 6, 2021 (analysis period); the start of the analysis period corresponds to seven days after individuals began receiving second doses of the Pfizer-BioNTech COVID-19 Vaccine. 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 … 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. 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/. 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. Jasmina Alatovic Detailed findings from this collaboration also will be submitted to a peer-reviewed journal. The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. 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. 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. Copyright © 2002-2021 Pfizer Inc. All rights reserved. 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. For all outcomes, vaccine effectiveness was measured from two weeks after the second dose. Amy.Rose@pfizer.com, Investor Relations The design of the trial allows for the evaluation of the various mRNA candidates simultaneously. On Thursday, the bloc also approved its … "The real … 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. Vaccine effectiveness was at least 97% against symptomatic COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines 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.
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