(IN BRIEF) Pfizer and BioNTech have received a recommendation for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. The recommendation includes the administration of a single dose for individuals aged 5 and older, as well as updated recommendations for children aged 6 months through 4 years. The European Commission will review the recommendation before making a final decision. The updated vaccine aims to provide improved protection against severe illness and hospitalization, and its application is pending with other regulatory authorities globally.
(PRESS RELEASE) MAINZ, 31-Aug-2023 — /EuropaWire/ — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. The Committee has also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.
The European Commission (EC) will review the CHMP’s recommendation and is expected to make a final decision soon. Following a decision from the EC, the updated vaccine will be ready to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.2
“This season’s vaccine is ready to ship as soon as the final regulatory decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises,” said Albert Bourla, Chairman and Chief Executive Officer at Pfizer. “It’s been nearly a year since many citizens in the European Union were vaccinated against COVID-19 and the updated formulation provides the opportunity for them to receive a vaccine more closely matched to current sublineages.”
“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are better matched to relevant circulating variants or sublineages to people worldwide, to support vaccinations in the upcoming fall and winter season,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally. The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalization.”
The CHMP’s recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. Further, the application included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Additional pre-clinical data demonstrate that serum antibodies induced by the updated COVID-19 vaccine, when compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, also effectively neutralize the globally dominant and recently WHO-designated variant of interest EG.5.1 (Eris)3.
Pfizer and BioNTech have also filed an application with the U.S. Food and Drug Administration (FDA) requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older. A decision is expected in the coming days. The companies have submitted data for the updated COVID-19 vaccine to other regulatory authorities around the world.
The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
AUTHORIZED USE IN THE EU:
COMIRNATY® ▼(Tozinameran) has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The vaccine is administered as a single dose in people 5 years of age and older, and as a three-dose series, 3 weeks apart, in infants and children from 6 months to 4 years who have not had COVID-19. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose; infants and children aged 6 months to 4 years are given 3 micrograms per dose. Additional doses may be administered to individuals aged 5 years and older who are severely immunocompromised in accordance with national recommendations. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.
In addition, COMIRNATY has also been granted standard MA for two adapted vaccines: COMIRNATY Original/Omicron BA.1, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.1 subvariant of SARS-CoV-2; and COMIRNATY Original/Omicron BA.4-5, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.4/BA.5 subvariant of SARS-CoV-2. COMIRNATY Original/Omicron BA.1 may be administered as a single dose in people aged 12 years and older who have received at least a primary vaccination course against COVID-19. COMIRNATY Original/Omicron BA.4-5 may be administered as a single dose regardless of prior vaccination status in people aged 5 years and older. Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19. There should be an interval of at least 3 months between administration of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 and the last prior dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
- Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
- There is an increased risk (<1/10,000 cases) of myocarditis and pericarditis following vaccination with COMIRNATY. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.
- Rare cases of acute peripheral facial paralysis; uncommon incidence of insomnia, hyperhidrosis and night sweats; and unknown incidence of paraesthesia, hypoaesthesia, erythema multiforme, heavy menstrual bleeding, extensive swelling of limb and facial swelling have been identified in post-marketing experience.
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e. g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may be lower in immunosuppressed individuals.
- As with any vaccine, vaccination with COMIRNATY, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of the vaccine.
- Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
- Very common side effects: injection site pain, injection site swelling, tiredness, headache, muscle pain, chills, joint pain, diarrhea, fever
- Common side effects: injection site redness, nausea, vomiting
- Uncommon side effects: enlarged lymph nodes (more frequently observed after the booster dose), feeling unwell, arm pain, insomnia, injection site itching, allergic reactions such as rash or itching, feeling weak or lack of energy/sleepy, decreased appetite, excessive sweating, night sweats
- Rare side effects: temporary one-sided facial drooping, allergic reactions such as hives or swelling of the face
- Very rare side effects: inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis), which can result in breathlessness, palpitations or chest pain, anaphylaxis, extensive swelling of vaccinated limbs; facial swelling, pins and needles/tingling, reduced sense of touch or sensation, a skin reaction that causes red spots or patches on the skin
- A large amount of observational data from pregnant women vaccinated with the initially approved COMIRNATY vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. COMIRNATY can be used during pregnancy. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the initially approved COMIRNATY vaccine is negligible. Observational data from women who were breast-feeding after vaccination have not shown a risk for adverse effects in breast-fed newborns/infants. COMIRNATY can be used during breast-feeding.
- No data are available yet regarding the use of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 during pregnancy. Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity between those COMIRNATY variant-adapted vaccines that have been clinically evaluated, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 can be used during pregnancy.
- No data are available yet regarding the use of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 during breast-feeding. Observational data from women who were breast-feeding after vaccination with the initially approved COMIRNATY vaccine have not shown a risk for adverse effects in breast-fed newborns/infants. COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 can be used during breast-feeding
- Interactions with other medicinal products or concomitant administration of COMIRNATY, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 with other vaccines has not been studied.
- Animal studies with COMIRNATY Original do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
- The safety of a COMIRNATY Original/Omicron BA.1 booster dose in individuals from 18 to ≤ 55 years of age is extrapolated from safety data from a subset of 315 adults 18 to ≤ 55 years of age who received a booster (fourth dose) of Omicron BA.1 30 µg (monovalent) after completing 3 doses of COMIRNATY. The most frequent adverse reactions in these participants 18 to ≤ 55 years of age were injection site pain (> 70%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills (> 30%) and arthralgia (> 20%).
- In a subset from Study 4 (Phase 3), 305 adults > 55 years of age who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty 5 to 12 months after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. The overall safety profile for the Comirnaty booster (fourth dose) was similar to that seen after the Comirnaty booster (third dose). The most frequent adverse reactions in participants > 55 years of age were injection site pain (> 60%), fatigue (> 40%), headache (> 20%), myalgia and chills (> 10%).
- The safety of a booster dose of COMIRNATY Original/Omicron BA.4-5 is inferred from safety data for a booster dose of COMIRNATY Original/Omicron BA.1, as well as for a booster dose of COMIRNATY Original.
- The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. As with any vaccine, vaccination with Comirnaty Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine recipients
- For complete information on the safety of COMIRNATY, COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5, always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.
The black equilateral triangle ▼ denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to medinfo@biontech.de, www.biontech.com or directly to BioNTech using email, telephone +49 6131 9084 0, or via the website.
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 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 August 30, 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 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 regulatory applications pending with the European Commission and the U.S. Food and Drug Administration (FDA) for an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine , data submitted for an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulatory authorities, qualitative assessments of available data, potential benefits, expectations regarding demand for COVID-19 vaccination, 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 COMIRNATY, or any vaccine candidate in the BNT162 program, 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 COMIRNATY, any vaccine candidate or any other vaccines that may result from the BNT162 program or any other COVID-19 program, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of COMIRNATY, any vaccine candidate or any future vaccine 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 COMIRNATY or any future vaccines 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 COMIRNATY, any vaccine candidates or any other potential vaccines that may arise from the BNT162 program, 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 COMIRNATY (including any requested amendments to the emergency use or conditional marketing authorizations and including the applications pending with the FDA and the European Commission for the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine), any vaccine candidates or other vaccines that may result from the BNT162 program or any other COVID-19 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including the authorization or approval of products or therapies developed by other companies; 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 excess inventory on-hand and/or in the channel or reduced revenues; 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 COMIRNATY or any potential future COVID-19 vaccines; 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 COMIRNATY; 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 DualityBio, 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 be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine, including the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine; qualitative assessments of available data and expectations of potential benefits; 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; BioNTech’s pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTech’s initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the availability of raw materials to manufacture a vaccine; our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; competition from other COVID-19 vaccines or related to BioNTech’s other 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 to prevent COVID-19 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; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; 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.
1 World Health Organization. COVID-19 Weekly Epidemiological Update. Available at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
2 Wiemken TL, Khan F, Nguyen JL, Jodar L, McLaughlin JM. Is COVID-19 seasonal? A time series modeling approach. medRxiv. 2022:2022.06.17.22276570.
3https://www.who.int/docs/default-source/coronaviruse/09082023eg.5_ire_final.pdf?sfvrsn=2aa2daee_1
Media Contacts:
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BioNTech
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SOURCE: BioNTech
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- Digi Communications N.V. announces the exercise of conditional share options by an executive director of the Company, for the year 2022, as approved by the Company’s Ordinary General Shareholders’ Meeting from 18 May 2021
- Digi Communications N.V. announces the availability of the instruction regarding the payment of share dividend for the 2022 financial year
- Digi Communications N.V. announces the availability of the 2022 Annual Report
- Digi Communications N.V. announces the general shareholders’ meeting resolutions from 18 August 2023 approving amongst others, the 2022 Annual Accounts
- 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!
- Írd újra Európa turizmusát a 3. CASSINI Hackathonon!
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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
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- 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
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- 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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- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- 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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