(IN BRIEF) Pfizer and BioNTech have announced positive topline results from a Phase 1/2 study of their mRNA-based combination vaccine program for influenza and COVID-19. The lead formulations showed robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. These results indicate the potential for a single injection to combat both respiratory diseases. The companies plan to initiate a pivotal Phase 3 trial in the coming months to further evaluate the vaccine candidates.
(PRESS RELEASE) MAINZ, 27-Oct-2023 — /EuropaWire/ — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced positive topline results from a Phase 1/2 study (NCT05596734) evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age. In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit. The data from the trial showed that the companies’ lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.
“We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19. This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world,” said Annaliesa Anderson, PhD, FAAM, Senior Vice President and Head, Vaccine Research and Development at Pfizer. “mRNA-based vaccines have demonstrated their ability to induce robust antibody and T-cell responses, and we look forward to starting Phase 3 clinical development. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines.”
“Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. Co-infections as well as consecutive respiratory infection during this period can further increase the risk of severe illness,” said Prof. Ugur Sahin, MD, CEO and Co-founder of BioNTech. “Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations who have a higher risk of severe illness.”
The topline results of the ongoing trial demonstrated that the combination formulations evaluated had a safety profile consistent with the safety profile of the companies’ COVID-19 vaccine. Immunogenicity results induced by lead formulations in the companies’ phase 1/2 trial showed point estimates for Geometric Mean Titer (GMT) ratios that were consistent with the criteria applied to regulatory approved vaccines against the respective influenza and SARS-CoV-2 strains. Point estimates for GMT ratios for all matched influenza vaccine strains with lead formulations were >1 relative to a licensed Quadrivalent Influenza Vaccine (QIV) given concomitantly with the Pfizer-BioNTech COVID-19 vaccine. A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months. Data from the Phase 1/2 trial will be published in a peer-reviewed journal.
Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and COVID-19 received Fast Track Designation from the U.S. Food and Drug Administration (FDA).
About Respiratory Diseases
SARS-CoV-2 led to a global pandemic with more than 6.5 million deaths and a severe socio-economic burden worldwide. While vaccinations can help address the disease, COVID-19 is expected to remain a circulating, severe respiratory disease, requiring adjustments of vaccines to variants of concern. This is reminiscent of influenza, another respiratory disease that requires repeated vaccinations due to its genomic instability resulting in modifications of the surface protein hemagglutinin. Each year, influenza results in up to one billion infections, five million hospitalizations, and 650,000 deaths worldwide.
INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION
INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
- You should NOT receive COMIRNATY® (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any ingredient of COMIRNATY or a previous dose of a Pfizer-BioNTech COVID-19 vaccine* or to any ingredient in these vaccines
*COMIRNATY (2023-2024 Formula) is made the same way as Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).
- There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination.Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of the face and throat
- A fast heartbeat
- A bad rash all over the body
- Dizziness and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following COMIRNATY have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding heart
- Fainting can happen after getting injectable vaccines including COMIRNATY. Your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine
- People with weakened immune systems may have a reduced immune response to COMIRNATY
- COMIRNATY may not protect all vaccine recipients
- Before getting COMIRNATY, tell your vaccination provider about all of your medical conditions, including if you:
- have any allergies
- had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the immune system
- are pregnant, plan to become pregnant, or are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
- Additional side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Injection Site reactions: pain, swelling, redness, arm pain
- General side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness.
These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about any side effects that concern you.
You may report vaccine side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html.
You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for full Prescribing Information for COMIRNATY.
AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)* is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age.
*Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine
EMERGENCY USE AUTHORIZATION
Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months through 11 years of age. 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.
IMPORTANT SAFETY INFORMATION
- A person should NOT get Pfizer-BioNTech COVID-19 Vaccine if they had a severe allergic reaction after a previous dose of any Pfizer-BioNTech COVID-19 vaccine or to any ingredients in these vaccines.
- There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, the vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of the face and throat,
- A fast heartbeat
- A bad rash all over the body
- Dizziness and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following Pfizer-BioNTech COVID-19 vaccines have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. Seek medical attention right away if your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
- Chest pain
- Shortness of breath or difficulty breathing
- Feelings of having a fast-beating, fluttering, or pounding heart
- Additional symptoms, particularly in children, may include:
- Fainting
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Persistent vomiting
- Persistent pain in the abdomen
- Unusual and persistent cool, pale skin
- Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination
- People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID-19 Vaccine
- The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone
- Tell your vaccination provider about all of your medical conditions, including if you:
- have any allergies
- has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- has a fever
- has a bleeding disorder or are on a blood thinner
- is immunocompromised or are on a medicine that affects the immune system
- is pregnant or is breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
- Side effects that have been reported with Pfizer-BioNTech COVID-19 vaccines include:
- Severe allergic reactions
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Injection site pain/tenderness
- Tiredness
- Headache
- Muscle pain
- Arm pain
- Fainting in association with injection of the vaccine
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- Dizziness
- Irritability
These may not be all the possible side effects. Serious and unexpected side effects may occur. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.
Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19 Vaccine(2023-2024 Formula) EUA” in the first line of box #18 of the report form.
In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for Pfizer-BioNTech COVID-19 Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver EUA Fact Sheet.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. 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. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. 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. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of October 26, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19 among healthy adults 18 to 64 years of age, including its potential benefits, plans to initiate a pivotal Phase 3 trial, Pfizer’s ambition of providing a broad portfolio of respiratory combination vaccines, 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 Pfizer and BioNTech’s COVID-19 vaccines, defined collectively herein as COMIRNATY (including qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations 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 pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 or pre-clinical data for Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates, including the data discussed in this release) in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data, including the risk that additional data against newer Omicron sublineages could differ from previously reported data; the ability to produce comparable clinical or other results for Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates, including the rate of vaccine effectiveness and safety and tolerability profile observed to date and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates to prevent COVID-19 caused by emerging virus variants; the risk that 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 pre-clinical 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 or other COVID-19 programs 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 existing or future pre-clinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates in additional populations, for a potential booster dose for COMIRNATY, any vaccine candidate or any potential future vaccines (including potential future annual boosters or re-vaccinations), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates, and if obtained, whether or when such emergency use authorizations or licenses, or existing emergency use authorizations, will expire or terminate; whether and when any applications that may be pending or filed for Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates (including any requested amendments to the emergency use or conditional marketing authorizations) 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 the authorization or approval of products or therapies developed by other companies; intellectual property and other litigation; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; the risk that demand for any products may be reduced, no longer exist or not meet expectations, which may lead to reduced revenues, excess inventory on-hand and/or in the channel which, for COMIRNATY, has resulted in inventory write-offs and other charges and could continue to result in inventory write-offs or other unanticipated changes; challenges related to and uncertainties regarding the timing of a transition to the commercial market for any of our products; uncertainties related to the public’s adherence to vaccines and boosters; risks related to our ability to achieve our revenue forecasts for Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test a vaccine; challenges related to our vaccine’s formulation, dosing 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 potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines or potential combination respiratory vaccines; the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand for our vaccines, which would negatively impact our ability to supply our vaccines within the projected time periods; whether and when additional supply or purchase agreements will be reached or existing agreements will be completed or renegotiated; 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; pricing and access challenges; challenges related to public confidence in, or awareness of Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, COMIRNATY or any of Pfizer’s other respiratory vaccine candidates; uncertainties around future changes to applicable healthcare policies and guidelines issued by the U.S. federal government in connection with the declared termination of the federal government’s COVID-19 public health emergency as of May 11, 2023; trade restrictions; potential third party royalties or other claims; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; 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, 2022 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
Biopharmaceutical New Technologies (BioNTech) 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 (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as 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 Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in infectious diseases, including the collaboration between BioNTech and Pfizer; current and future clinical trials of BioNTech and Pfizer’s mRNA-based combination vaccine candidates for influenza and COVID-19, including statements regarding the timing of initiation and completion of studies or trials, including the planned initiation of a pivotal Phase 3 trial, related preparatory work and the availability of results; timing for any data readouts; the potential safety and efficacy of BioNTech’s product candidates; BioNTech’s anticipated market opportunity and size for its product candidates; qualitative assessments of available data and expectations of potential benefits, including top-line results from a Phase 1/2 trial evaluating the safety, tolerability and immunogenicity of BioNTech and Pfizer’s mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age; regulatory submissions and regulatory approvals or authorizations and expectations regarding manufacturing, distribution and supply; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment; and expected regulatory recommendations to adapt vaccines to address new variants or sublineages. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: 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 data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; future commercial demand and medical need; the availability of raw materials to manufacture a vaccine; the formulation, dosing schedule and attendant storage, distribution and administration requirements of BioNTech’s vaccines, including risks related to storage and handling after delivery; competition from other products and product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; 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; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for BioNTech’s product candidates; the ability of BioNTech’s COVID-19 vaccines, including Pfizer’s and BioNTech’s mRNA-based combination vaccine candidates for influenza and COVID-19, to prevent COVID-19 and/or influenza caused by emerging virus variants; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTech’s COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech, including Pfizer’s and BioNTech’s mRNA-based combination vaccine candidates for influenza and COVID-19; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates, including Pfizer’s and BioNTech’s mRNA-based combination vaccine candidates for influenza and COVID-19; BioNTech’s ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech’s ability to effectively scale BioNTech’s production capabilities and manufacture BioNTech’s products, including BioNTech’s target COVID-19 vaccine production levels, and BioNTech’s product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2023 and in subsequent filings made by BioNTech with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.
Media Contacts:
Pfizer:
Media Relations:
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations:
+1 (212) 733-4848
IR@pfizer.com
BioNTech:
Media Relations:
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations:
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
SOURCE: BioNTech
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- Русские эмигранты усиливают призывы «Я хочу, чтобы вы жили» через искусство
- BevZero Introduces State-of-the-Art Mobile Flash Pasteurization Unit to Enhance Non-Alcoholic Beverage Stability at South Africa Facility
- Russian Emigrés Amplify Pleas of “I Want You to Live” through Art
- Digi Communications NV announces the release of H1 2023 Financial Results
- Digi Communications NV Announces Investors Call for the H1 2023 Financial Results
- Digi Communications N.V. announces the convocation of the Company’s general shareholders meeting for 18 August 2023 for the approval of, among others, the 2022 Annual Report
- “Art Is Our Weapon”: Artists in Exile Deploy Their Talents in Support of Peace, Justice for Ukraine
- Digi Communications N.V. announces the availability of the 2022 Annual Financial Report
- “AmsEindShuttle” nuevo servicio de transporte que conecta el aeropuerto de Eindhoven y Ámsterdam
- Un nuovo servizio navetta “AmsEindShuttle” collega l’aeroporto di Eindhoven ad Amsterdam
- Digi Communications N.V. announces the conclusion of an amendment agreement to the Facility Agreement dated 26 July 2021, by the Company’s Spanish subsidiary
- Digi Communications N.V. announces an amendment of the Company’s 2023 financial calendar
- iGulu F1: Brewing Evolution Unleashed
- Почему интерактивная «Карта мира» собрала ключевые антивоенные сообщества россиян по всему миру и становится для них важнейшим инструментом
- Hajj Minister meets EU ambassadors to Saudi Arabia
- Online Organizing Platform “Map of Peace” Emerges as Key Tool for Diaspora Activists
- Digi Communications N.V. announces that conditional stock options were granted to executive directors of the Company based on the general shareholders’ meeting approval from 18 May 2021
- Digi Communications N.V. announces the release of the Q1 2023 financial results
- AMBROSIA – A MULTIPLEXED PLASMO-PHOTONIC BIOSENSING PLATFORM FOR RAPID AND INTELLIGENT SEPSIS DIAGNOSIS AT THE POINT-OF-CARE
- Digi Communications NV announces Investors Call for the Q1 2023 Financial Results presentation
- Digi Communications N.V. announces the amendment of the Company’s 2023 financial calendar
- Digi Communications N.V. announces the conclusion of two Facilities Agreements by the Company’s Romanian subsidiary
- Digi Communications N.V. announces the conclusion of a Senior Facility Agreement by the Company’s Romanian subsidiary
- Patients as Partners Europe Returns to London and Announces Agenda Highlights
- GRETE PROJECT RESULTS PRESENTED TO TEXTILE INDUSTRY STAKEHOLDERS AT INTERNATIONAL CELLULOSE FIBRES CONFERENCE
- Digi Communications N.V. announces Digi Spain Telecom S.L.U., its subsidiary in Spain, entered into an investment agreement with abrdn to finance the roll out of a Fibre-to-the-Home (FTTH) network in Andalusia, Spain
- XSpline SPA / University of Linz (Austria): the first patient has been enrolled in the international multicenter clinical study for the Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment (CRT-DRIVE)
- Franklin Junction Expands Host Kitchen® Network To Europe with Digital Food Hall Pioneer Casper
- Unihertz a dévoilé un nouveau smartphone distinctif, Luna, au MWC 2023 de Barcelone
- Unihertz Brachte ein Neues, Markantes Smartphone, Luna, auf dem MWC 2023 in Barcelona
- Digi Communications N.V. announces conditional stock options granted to a Director of the Company based on the general shareholders’ meeting approval from 28 December 2022
- Digi Communications N.V. announces the release of the 2022 Preliminary Financial Results
- CAMPAIGNS FOR HUMANITY: MARKETING AGENCY ANNOUNCES €10,000 AWARDS FOR RUSSIANS SUPPORTING UKRAINE
- One Year Since the Invasion: New Series Highlights Everyday People Transformed by War into Heroes
- Digi Communications N.V. announces Investors Call for the presentation of the 2022 Preliminary Financial Results
- BevZero Receives Top Environmental Certification
- Thompson Duke Industrial Attains CE Certification for its Cannabis Vaporizer Cartridge Filling Equipment
- Modern Media Hub Takes Huge Leap with Financing Help of Cap Expand Partners
- Digi Communications N.V. announces the release of the Financial Calendar for 2023
- Digi Communications N.V. announces the exercise of stock options by two of the Directors of the Company
- Tanduay Is First Asian Rum to Enter Austrian Market
- Digi Communications N.V. Announces the Resolutions of the General Shareholders’ Meeting from 28 December 2022, approving, amongst others, the 2021 Annual Accounts
- MIGUN LIFE's new personal healthcare products are unveiled, heralding the grand first debut at CES 2023
- Digi Communications N.V. announces that the Romanian version of the Annual Financial Report for the year ended December 31, 2021 for the Digi Communications N.V. Group is available
- Digi Communications N.V. Announces Convocation of the Company’s general shareholders meeting for 28 December 2022 for the approval of, among other items, the 2021 Annual Report
- Digi Communications N.V. Announces the availability of the Annual Financial Report for the year ended December 31, 2021 for Digi Communications N.V. Group
- Digi Communications N.V.’s Romanian subsidiary was designated winner of the auction organised for the allocation of certain radio frequency entitlements in 2600 MHz and 3400-3800 MHz bands
- Digi Communications NV announces the release of the Q3 2022 Financial Results
- Digi Communications N.V. announces a Subsequent Amendment of the Company’s 2022 financial calendar
- Digi Communications NV announces Investors Call for the Q3 2022 Financial Results presentation
- Sygnum Bank and Artemundi tokenize Warhol’s Marilyn Monroe artwork
- Your Daily Commutes Will be Seamless, Connected and Productive.
- The secondary market platform THELAPHANT.IO introduces, for the first time in Israel: "a stock liquidity plan" for high-tech employees and companies
- Teavaro and CDP Institute Offer Free Online Course on Identity Resolution
- Digi Communications N.V. announces a Subsequent Amendment of the Company’s 2022 financial calendar
- Digi Communications N.V. announces an Amendment of the Company’s 2022 financial calendar
- 12-month real-world achievements for Diabeloop’s Automated Insulin Delivery (AID):
- Digi Communications N.V. announces the availability of the Instruction regarding the Payment of Dividends for the Financial Year 2021
- Simplify Content za usluge organskog Content Marketinga otvara svoja vrata poduzećima da (zajedno) uspješno kreiraju kvalitetan i relevantan sadržaj za potencijalne i postojeće klijente
- Digi Communications N.V. announces the approval of interim dividend distribution and updates regarding the 2022 Financial Calendar
- A new, creativity-based educational method increases the ability to solve problems with young people, in the social field, or when building a team in the company
- Digi Communications NV announces the release of the H1 2022 Financial Results
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- Digi Communications NV announces Investors Call for the H1 2022 Financial Results
- Digi Communications N.V. Announces the update of its 2022 Financial Calendar
- Digi Communications N.V. Announces the conclusion by the Company’s Spanish subsidiary of an amendment agreement to the facility agreement dated 26 July 2021
- Customer Data Platform Industry Grew Strongly in First Half of 2022: CDP Institute Report
- Metadeq Announces Breakthrough Non-Invasive Blood Test that Solves NASH Diagnosis Problem
- Η HBC Consulting Expert θεωρεί παράλογη την εμπλοκή του κυπριακού δικαστηρίου στην υπόθεση κληρονομιάς από τη χήρα του ολιγάρχη Μπόσοφ
- Esperto della società di consulenza HBC: le autorità italiane non hanno permesso a Katerina Bosov di vendere la villa del marito
- HBC Consulting Expert considers senseless the involvement of the Cypriot court in the case of inheritance by the widow of oligarch Bosov
- Fusion BPO Services is Opening New Center in Kosovo
- Hi-SIDE demonstrates an integrated high speed satellite data chain architecture at data rates exceeding 10 Gigabits per second
- Digi Communications N.V. announces that a joint venture of its subsidiary in Romania designated as one of the winners of the auction organized by the Belgian Institute for Postal Services and Telecommunications for the allocation of mobile spectrum frequency user rights
- KI-basierte Geldanlage für Privatpersonen – Velvet AutoInvest erhält 1,3 Mio. USD Seed-Investment
- Haizol Now Offer 3D Printing Services to Customers Worldwide
- Caravel Capital Fund Showcased At Secure Spectrum’s Hedge Fund Seminar
- Diabeloop, a key player in therapeutic AI applied to insulin delivery, announces 70 million euros new financing round to accelerate its international expansion
- Digi Communications NV Announces Availability of the 2021 Preliminary Annual Report (including the Company’s audited non-statutory Consolidated financial statements issued as per IFRS EU)
- Digi Communications N.V. Announces that conditional stock options were granted to executive directors of the Company and to directors and employees of the Company’s Romanian Subsidiary
- Caravel Capital Investments Inc. Founding Partner to Speak at Secure Spectrum Hedge Fund Seminar
- Digi Communications NV announces a correction of clerical errors by Amending the Q1 2022 Financial Report
- Digi Communications NV announces the release of Q1 2022 Financial Results
- Digi Communications N.V. announces Investors Call for the Q1 2022 Financial Results presentation
- Yield Crowd Tokenizes US $50M Real Estate Portfolio on Stellar Blockchain
- Digi Communications N.V. Announces an Amendment to the Financial Calendar for 2022
- Diabeloop presents new real-life results of DBLG1® System: Confirmed improvement in Time In Range +18.4 percentage points; Reduction of time spent in hypoglycemia to only 0.9%
- How two female entrepreneurs are redefining the lake travel industry
- Vil du være med å utvikle fremtidens bærekraftige reiseliv?
- Mettiti alla prova con la terza edizione del CASSINI Hackathon per rivitalizzare il settore turistico
- Προκαλέστε τον εαυτό σας στο 3ο CASSINI Hackathon και στοχεύστε την αναζωογόνηση του τουρισμού!
- Participez au 3e Hackathon CASSINI et relevez le défi de redynamiser le tourisme!
- 3. CASSINI Hackathon zur Neubelebung des Tourismus: Stellen Sie sich der Herausforderung!
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- Diabeloop adapts its self-learning, personalized insulin automatization software to be used with insulin pens
- Amadeus unveils five defining trends for the US group travel and events industry in 2022
- On World Bipolar Day ALCEDIAG announces EIT Health supported EDIT-B Consortium validating innovative blood diagnostic test for bipolar disorder
- Global & Europe Mental Health Software and Devices Market to Witness a Revenue of USD 13367.12 Million by 2030 by Growing with a CAGR of 13.28% During 2021-2030; Increasing Concern for Mental Health Disorders to Drive Market Growth
- Digi Communications NV announces the release of the 2021 Preliminary Financial Results
- Digi Communications NV announces Investors Call for the 2021 Preliminary Financial Results presentation
- At MWC in Barcelona, Amphenol will be exhibiting its wide offering for wireless service providers – including Open RAN compatible active 5G antennas
- ELIOS combined with cataract surgery delivers significant IOP reduction out to 8 years
- Tableau comparatif des pays : les caractéristiques à connaître avant de se développer à l’international
- Smart exosomes from an Australian technology leader
- Bucharest Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Transmetrics AI is Applied by DB Schenker to Improve Land Transport Network in Bulgaria
- Digi Communications N.V.: Announces repayment of an aggregate amount of approx. EUR 272 million of the Group’s financial debt
- El Liceo Europeo vence el Premio Zayed a la Sustentabilidad 2022 en Europa y Asia Central
- Framework rebrands to daappa, heralding a new phase in fintech solutions designed for private markets
- Digi Communications N.V. Announces the publishing of the Financial Calendar for 2022
- Manufacturing giant Haizol expands their offices in China
- Patients and R&D Leaders Jointly Present at EU Conference on Progress with Patient-Input to Transform Medicine Development
- Seminário Bíblico sobre “O Cumprimento da Palavra de Jesus no Mundo de Hoje”
- 'I Love fruit & veg from Europe': Weihnachten in der Schweiz ist gesund und voller Aromen
- Fidupar Now Live on Framework’s Core Solution
- Maya Miranda Ambarsari launches InterconnectDATA information platform for authentic data
- Digi Communications N.V. Announces that the offer of the Company’s Romanian subsidiary was designated winner of the auction organised for the allocation of certain radio frecquency entitlements
- New dating site aimed at people with mental health problems launches in Switzerland
- BITSCore Tests Satellite Cyber-Security and Ride-Share Algorithms on Australian Rocket
- StatusMatch.com ed Emirates collaborano per aiutare i frequenti viaggiatori italiani a tornare in volo
- StatusMatch.com and Emirates partner up to help Italian frequent flyers get back in the air
- MinDCet drivers and FTEX powertrain solutions enable EV GaN applications
- Digi Communications NV announces the release of the Q3 2021 Financial Results
- Origami and citoQualis Team up for Startups
- Digi Communications NV announces Investors Call for the Q3 Financial Results presentation
- Digi Communications N.V. announces the extraordinary general meeting’s resolution from 4 November 2021, approving the appointment of KPMG N.V. as the Company’s statutory auditor for the 2021 financial year
- Digi Communications N.V. announces The solution reached by the Bucharest Court of Appeal regarding the investigation conducted by the Romanian National Anticorruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V. Announces the results of the auction organised by the Portuguese Authority for Telecommunications
- Haizol expands its capabilities to include component assembly and product development
- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
- Rockegitarist-Sensasjon Rocky Kramer Har Fått Hovedrollen I Mutt Productions Filmen Rockin’ In Time
- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
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- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
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- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
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- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
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- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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