BNTX - Earnings announcements

MAINZ, Germany, April 21, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company")) will announce its financial results for the first quarter 2026 on Tuesday, May 5, 2026. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available via this l

BioNTech on track for a catalyst-rich year with six late-stage data readouts expected across immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies Increased focus on PD-L11/VEGF-A bispecific immunomodulator pumitamig with eight global Phase 3 clinical trials planned to be ongoing for year-end in collaboration with Bristol Myers Squibb Full year 2025 revenues of €2.9 billion2, net loss of €1.1 billion (adjusted3 net loss of €0.1 billion) and diluted loss per share of €4.70 ($5.314) (adjusted3 diluted loss per share of €0.48 ($0.554)) Strong financial position continues to de-risk execution with cash, cash equivalents and security investments of €17.2 billion5Expect 202

MAINZ, Germany, February 24, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company")) will announce its financial results for the fourth quarter and full year 2025 on Tuesday, March 10, 2026. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (1:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will

Continued clinical execution of oncology strategy with focus on two pan-tumor programs, including combination approaches to address the full continuum of cancer from early to late disease stagesDemonstrated encouraging anti-tumor activity and manageable safety profile of pumitamig (BNT327/BMS986545), a bispecific antibody candidate targeting PD-L11 and VEGF-A, in first disclosed interim data from global Phase 2 trial in extensive-stage small cell lung cancer Plan to initiate additional pivotal trials for pumitamig in first-line microsatellite stable colorectal cancer and first-line gastric cancerLaunched variant-adapted COVID-19 vaccine for the 2025/2026 vaccination season in multiple region

MAINZ, Germany, October 27, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company")) will announce its financial results for the third quarter 2025 on Monday, November 3, 2025. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EST (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available v

Continued execution of BioNTech's oncology strategy with focus on two pan-tumor programs including two announced transactions: mRNA-based cancer immunotherapy candidates and BNT327, a bispecific antibody candidate targeting PD-L11 and VEGF-AEntered a global strategic co-development and co-commercialization collaboration with Bristol Myers Squibb ("BMS") to jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor typesAnnounced strategic transaction to acquire CureVac N.V. ("CureVac") to strengthen the research, development, manufacturing and commercialization of mRNA-based cancer immunotherapy candidatesPresented multiple clinical update

MAINZ, Germany, July 21, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company")) will announce its financial results for the second quarter 2025 on Monday, August 4, 2025. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available via

Continued oncology pipeline advancement with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator BNT327, a bispecific antibody targeting PD-L1 and VEGF-A1, and mRNA cancer immunotherapies Presented multiple clinical updates across oncology pipeline underlining BioNTech's combination strategy in oncology with first data presented for the novel combination of BNT327 plus antibody-drug conjugates ("ADCs") Development and commercial preparation for a 2025/2026 season variant-adapted COVID-19 vaccine First quarter 2025 revenues of €0.2 billion2, net loss of €0.4 billion and basic and diluted loss per share of €1.73 ($1.823) Maintained strong financial positio

MAINZ, Germany, April 22, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company")) will announce its financial results for the first quarter 2025 on Monday, May 5, 2025. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available via thi

Advanced oncology pipeline including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies Multiple data readouts expected in 2025 and 2026 aimed at providing clinical proof of BioNTech's pipeline strategy and advancing the Company towards becoming a diversified multi-product oncology portfolio company by 2030 Completed acquisition of Biotheus securing full control of next-generation immunomodulator candidate BNT327, a bispecific antibody targeting PD-L1 and VEGF-A1 Successfully launched JN.1- and KP.2-adapted COVID-19 vaccines across different coun

MAINZ, Germany, February 24, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company")) will announce its financial results for the fourth quarter and full year 2024 on Monday, March 10, 2025. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (1:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast wil

Presented clinical data for multiple assets across modalities, including bispecific antibody candidate BNT327/PM8002 and mRNA cancer vaccine candidate BNT113 based on BioNTech's FixVac platform Initiated two Phase 2 dose optimization trials with BNT327/PM8002 in small-cell lung cancer and in triple-negative breast cancer to inform planned pivotal Phase 3 trialsPhase 2 clinical trial on track to evaluate mRNA-based individualized cancer vaccine candidate autogene cevumeran (BNT122/RO7198457) as an adjuvant treatment in patients with high-risk muscle-invasive urothelial cancerSuccessfully launched variant-adapted COVID-19 vaccines for the 2024/2025 vaccination season in multiple regionsReports

MAINZ, Germany, October 21, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the third quarter 2024 on Monday, November 4, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast w

Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111Launched updated variant-adapted COVID-19 vaccine in the European Union ("EU"), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application ("sBLA") with the United States Food and Drug Administration ("U.S. FDA")Reiterates guidance for total revenues in the range of €2.5-3.1 billionReports second quarter 2024 revenues of €128.7 million, net loss of €807.8 million and loss per share of €3.36 ($3.621)Invested €525.6 million or approximately 90% of the Company's total R&D spend in Q2 in non

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be

Advancing toward goal of ten or more potentially registrational trials running by the end of 2024: first patient dosed in Phase 3 clinical trial evaluating BNT323/DB-1303 in HR+ HER2-low chemotherapy-naïve metastatic breast cancer patients, and a second Phase 3 trial with BNT323/DB-1303 in recurrent endometrial cancer planned to start soonPresented clinical data at the American Association for Cancer Research ("AACR") Annual Meeting for individualized and off-the-shelf mRNA-based cancer vaccine candidates based on iNeST and FixVac platforms, including three-year follow-up data of an investigator-initiated trial in patients with resected pancreatic ductal adenocarcinoma ("PDAC")Planning to sh

MAINZ, Germany, April 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the first quarter 2024 on Monday, May 6, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available v

  Advanced oncology pipeline in mid- and late-stage with plans to have ten or more potentially registrational oncology trials running by the end of 2024Aiming for first oncology launch in 2026 and ten indication approvals by 2030 as part of BioNTech's strategy to develop combinatorial and synergistic therapeutic approachesEntered strategic collaborations with Biotheus, DualityBio, Medilink and OncoC4 to complement clinical oncology pipeline with innovative antibody-drug conjugate (ADC) and immuno-modulatory programsAnnemarie Hanekamp appointed as Chief Commercial Officer effective July 1, 2024Delivered over 400 million COVID-19 vaccine doses worldwide in 2023, including successfully laun

MAINZ, Germany, March 6, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the full year and fourth quarter 2023 on Wednesday, March 20, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast wi

Positive clinical data updates across multiple drug classes including antibody-drug conjugate (ADC) candidates BNT323/DB-1303, BNT325/DB-1305, CAR-T candidate BNT211, T cell therapy candidate BNT221 and mRNA cancer vaccine candidate BNT116Progress across the oncology pipeline with multiple late-stage trials initiated since third quarter startNew and expanded strategic collaborations reflect BioNTech's commitment to delivering transformational therapies for oncology and infectious diseasesSuccessful launches of Omicron XBB.1.5-adapted monovalent COVID-19 vaccine in markets worldwide Updated 2023 COVID-19 vaccine revenue guidance of around €4 billion Guidance reduction of planned 2023 R&D expe

MAINZ, Germany, October 23, 2023 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the third quarter 2023 on Monday, November 6th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2023. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance. The slide presentation and audio of the

Significant pipeline advancement highlighted by the initiation of BNT316/ONC-392 Phase 3 pivotal trial and multiple trials planned to start across the oncology portfolioPositive data updates across multiple technology platforms including ADC candidate BNT323/DB-1303, anti-CTLA4 monoclonal antibody candidate BNT316/ONC-392 and CAR-T candidate BNT211 Preparation for launch of Omicron XBB.1.5-adapted monovalent COVID-19 vaccine as recommended by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other health authorities; deliveries expected to start as early as September, subject to regulatory approvalReiterates COVID-19 vaccine revenue guidance of approximately €5

MAINZ, Germany, July 24, 2023 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the second quarter 2023 on Monday, August 7th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2023.  To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance. The slide presentation and audio of

COVID-19 vaccine franchise focused on vaccine adaptation readiness ahead of the fall season and advancing next generation vaccine candidates and combinationsBioNTech and partner OncoC4 plan to start a Phase 3 clinical trial evaluating anti-CTLA-4 antibody BNT316 (ONC-392) as monotherapy in NSCLC patients who progress after PD-1/PD-L1 treatment Added new class of precision therapeutics to clinical-stage oncology portfolio, with next-generation Antibody-Drug Conjugate (ADC) candidatesPresenting clinical data on antibody candidate BNT316 (ONC-392), ADC candidate BNT323 (DB-1303) and CAR-T candidate BNT211 at the 2023 American Society of Clinical Oncology Annual Meeting Broadened clinical-stage

MAINZ, Germany, April 24, 2023 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the first quarter 2023 on Monday, May 8th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter 2023. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance. The slide presentation and audio of t

Expanded and advanced oncology pipeline to 20 programs in 24 ongoing clinical trials including five ongoing randomized Phase 2 clinical trials; multiple trials with registrational potential expected to be initiated in 2023 and 2024Announced licensing agreement with OncoC4 to complement the Company's oncology portfolio with clinical stage next-generation immune checkpoint modulator; a randomized Phase 3 trial planned to start in 2023Initiated Phase 1 trials for four mRNA vaccine candidates in the infectious disease fieldApproximately 2 billion doses of COMIRNATY® invoiced in 2022, including approximately 550 million doses of Omicron-adapted bivalent COVID-19 vaccines Fourth quarter and full y

MAINZ, Germany, March 13, 2023 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the full year and fourth quarter 2022 on Monday, March 27th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the fourth quarter and full year 2022.  To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance. The sl

BioNTech and Pfizer continue to build on global COVID-19 vaccine leadership with first-to-market Original/Omicron BA.4/BA.5-adapted bivalent vaccine launches across multiple countries and regions worldwide Approximately 300 million doses of the Original/Omicron BA.1- and BA.4/BA.5-adapted bivalent vaccines invoiced as of mid-October 2022 In infectious diseases, Phase 1 trial initiated with a combination vaccine candidate, incorporating the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and Pfizer's quadrivalent modified RNA (modRNA) influenza vaccine candidate, both based on BioNTech's proprietary mRNA platformContinued oncology pipeline expansion with three new first-in

Mainz, Germany, October 24, 2022 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the third quarter 2022 on Monday, November 7th, 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the third quarter 2022. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance. The slide presentat

Second quarter revenues of €3.2 billion1, net profit of €1.7 billion and fully diluted earnings per share of €6.45 ($6.872) as well as first half 2022 revenues of €9.6 billion, net profit of €5.4 billion and fully diluted earnings per share of €20.69 ($18.922)Reiterates BioNTech COVID-19 2022 vaccine revenue guidance of €13 billion to €17 billionPreparing for potential launch of two variant-adapted bivalent COVID-19 vaccines containing the original strain and Omicron BA.1 or BA.4/5 spike protein as recommended by U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators; expect to be able to begin delivering Omicron-adapted vaccines as early as October 202

Mainz, Germany, July 25, 2022 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the second quarter 2022 on Monday, August 8th, 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2022. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance. The slide presentation and audio of the web

First quarter revenues of €6.4 billion1, net income of €3.7 billion and fully diluted earnings per share of €14.24 ($15.972)Reiterates BioNTech COVID-19 2022 vaccine revenue guidance of €13 billion to €17 billionFirst-in-class CAR-T program targeting CLDN-6 (BNT211) in solid tumors showed manageable safety profile and signs of clinical activity; preliminary Phase 1/2 data presented at AACR Annual Meeting 2022Continued pipeline expansion to 16 clinical stage oncology programs in 20 ongoing clinical trials  Conference call and webcast scheduled for May 9, 2022, at 8:00 am ET (2:00 pm CET) MAINZ, Germany, May 9, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ:BNTX, "BioNTech" or the ", Com

Mainz, Germany, April 26, 2022 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the first quarter 2022 on Monday, May 9th, 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter 2022. The slide presentation and audio of the webcast will be available via this link. To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID: United States inter

Fourth quarter and full year revenues of €5.5 billion1 and €19.0 billion1, respectivelyFull year net income of €10.3 billion and fully diluted earnings per share of €39.63 ($46.872)Expect to authorize a share repurchase program of up to $1.5 billion over the next two years and will propose a special cash dividend of €2.00 per share, pending approval at the Annual General MeetingApproximately 2.6 billion doses of COMIRNATY®/BNT162b2 delivered to more than 165 countries and regions worldwide in 2021, including more than 1 billion doses to low- and middle-income countriesReiterate BioNTech COVID-19 2022 vaccine revenue guidance of €13 billion to €17 billionSigned orders for 2022 delivery increa

MAINZ, GERMANY, March 16, 2022 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the full year and fourth quarter 2021 on Wednesday, March 30th, 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the fourth quarter and full year 2021. The slide presentation and audio of the webcast will be available via this link. To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference

Delivered more than 2 billion doses of COMIRNATY/BNT162b2 in 2021 as of November 2ndDemonstrated progress in expanding access to COVID-19 vaccine globally, including Biologics License Application (BLA) approval by U.S. FDA, regulatory authorizations of booster doses in multiple populations and first U.S. Emergency Use Authorization (EUA) in children for a COVID-19 vaccineExpansion of clinical oncology portfolio with first patient dosed in Phase 2 trial of mRNA-based individualized immunotherapy autogene cevumeran (BNT122, RO7198457) in circulating tumor DNA positive high-risk colorectal cancer patients after adjuvant treatmentPositive clinical data from BioNTech's oncology pipeline to be hig

Mainz, Germany, October 27, 2021 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the third quarter on Tuesday, November 9th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2021. The slide presentation and audio of the webcast will be available via this link. To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID: United States interna

More than one billion doses of BNT162b2 vaccine supplied to more than 100 countries or territories worldwide as of July 21, 2021Signed agreements for approximately 2.2 billion doses of BNT162b2 in 2021 as of July 21, 2021In oncology, the first patients were dosed in randomized Phase 2 trials for two FixVac programs, BNT111 and BNT113, and first-in-human Phase 1 trials started for BNT152+153 and BNT221BioNTech's oncology pipeline has advanced: currently 15 product candidates in 18 ongoing trials Conference call and webcast scheduled for August 9, 2021, at 8:00 a.m. ET (2:00 p.m. CET) MAINZ, Germany, August 9, 2021 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Compa

Mainz, Germany, August 2, 2021 (GLOBE NEWSWIRE) – BioNTech SE (NASDAQ:BNTX, "BioNTech" or "the Company"))) will announce its financial results for the second quarter on Monday, August 9th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2021. The slide presentation and audio of the webcast will be available via this link. To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID: United States inter

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine in th

U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediatelyFirst authorization for a COVID-19 vaccine represents a breakthrough scientific achievement to help combat this devastating pandemic The companies previously signed an agreement to supply a total of 40 million doses to the U.K. with delivery in 2020 and 2021 U.S. FDA and EU EMA decisions on authorization are expected in December NEW YORK and MAINZ, GERMANY, December 2, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in th

EMA confirms successful application for Conditional Marketing Authorization for BNT162b2, which Pfizer and BioNTech submitted yesterday In addition to submission to EMA, FDA and U.K. MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world Data from the Phase 3 clinical study demonstrated a vaccine efficacy rate for BNT162b2 of 95% against COVID-19, with no safety concerns observed to date NEW YORK and MAINZ, GERMANY, December 1, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have submitted on Monday, November 30, 2020,