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The updated COVID-19 vaccine is tailored to the Omicron JN. 1 lineage of SARS-CoV-2 and is for Americans 6 months of age and older.
The recommendation is based on preclinical and epidemiological data showing that the monovalent COVID-19 vaccine adapted to JN. 1 generates an enhanced immune reaction compared to the JN. 1 sublineages.
The doses will be ready to be shipped to the relevant EU Member States without delay after authorisation by the European Commission.
NEW YORK and MAINZ, Germany, June 27, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for human use (CHMP) has recommended marketing authorization of the companies’ Omicron JN. 1 adapted monovalent COVID-19 vaccine (COMIRNATY® JN. 1) for active immunization to save COVID-19 caused by SARS-CoV-2 in 6 Americans. people over 6 months and older. The adaptation is based on advice from the World Health Organization (WHO) Technical Advisory Group on COVID-19 vaccine composition and the European Medicines Agency’s Emergency Working Group (ETF) to update COVID-19 vaccines to target the SARS-CoV-2. JN. 1 variant for the 2024-2025 vaccination campaign. The ETF said that “evidence indicates that targeting JN. 1 will help vaccine efficacy as SARS-CoV-2 continues to evolve. “1, 2
The European Commission (EC) will review the CHMP’s advice and is expected to make a final decision soon. Following the EC ruling, the updated vaccine can be sent without delay to the relevant EU Member States. Pfizer and BioNTech are producing the monovalent vaccine. The Omicron-adapted COVID-19 vaccine is at risk1 to ensure the availability of sources ahead of the upcoming fall and winter season, when demand for COVID-19 vaccination is expected to increase. 3
The CHMP’s advice is based on the framework of past clinical, non-clinical and real-world evidence supporting the protection and efficacy of the Pfizer and BioNTech COVID-19 vaccines. The application also included preclinical and production knowledge that appears to be the monovalent COVID-19 vaccine JN. 1-adapted vaccine generates an especially accelerated reaction against several Omicron JN. 1 sublineages, adding KP. 2, KP. 3, and other lately circulating sublineages, to the company-adapted monovalent Omicron XBB. 1. 5. COVID-19 vaccine. 4
Pfizer and BioNTech are initiating ongoing programs with the U. S. Food and Drug Administration. The U. S. Food and Drug Administration (FDA), in line with a recent FDA recommendation, for approval of its Omicron-adapted monovalent COVID-19 KP. 2 vaccines for Americans 6 months of age and older. Corporations will continue to monitor the evolution of COVID-19 epidemiology and take mandatory measures to meet global public health needs.
Pfizer and BioNTech’s COVID-19 vaccines (COMIRNATY)® belong to BioNTech’s proprietary mRNA generation and were developed through both companies. BioNTech holds marketing authorization for COMIRNATY® and its adapted vaccines (COMIRNATY® Original/Omicron BA. 4-5; COMIRNATY® Omicron XBB. 1. 5) in the United States, the European Union, the United Kingdom, 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® ▼ has received a marketing authorization (MAA) from the European Commission to protect coronavirus disease 2019 (COVID-19) in people aged 6 months or older. The vaccine is administered in a single dose in people aged five years and older, and in a series of three doses, in infants and children older than six months to four years who have not had COVID-19, receiving the first two doses three dose. . weeks apart, followed by a third dose administered at least 8 weeks after the second dose. Adults and adolescents over 12 years of age receive 30 micrograms per dose; children five to 11 years old receive 10 micrograms per dose; Infants and children older than 6 months to 4 years receive 3 micrograms per dose. Additional doses would possibly be given to Americans ages 5 and older who are severely immunocompromised, in line with national recommendations. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that there must be sufficiently physically powerful knowledge about the quality, protection and efficacy of the vaccineArray
In addition, COMIRNATY has also received a popular marketing authorization for two adapted vaccines: COMIRNATY Original/Omicron BA. 4-5, whose mRNA encodes the wild-type spike protein and the Omicron BA. 4/BA. 5. SARS-CoV-2 subvariant; and COMIRNATY Omicron XBB. 1. 5, which is the mRNA that encodes the spike protein of the Omicron XBB. 1. 5 subvariant of SARS-CoV-2.
COMIRNATY Omicron XBB. 1. 5 could be administered as a single dose regardless of previous vaccination status in Americans five years of age and older. Children ages 6 months to four years can get one or three doses depending on whether they’ve had a number one vaccination or had COVID-19. A period of at least 3 months will have to elapse between the administration of COMIRNATY Original/Omicron BA. four-five or COMIRNATY Omicron XBB. 1. five and the last previous dose of a COVID vaccine. -19 vaccine.
IMPORTANT SAFETY INFORMATION
Cases of anaphylaxis have been reported. Adequate medical care and follow-up are necessary in case of an anaphylactic reaction after administration of the vaccine.
There is an increased, but very rare (<1/10,000 cases) risk of myocarditis and pericarditis after vaccination with COMIRNATY. These situations can extend as little as a few days after vaccination and occur most often within 14 days. They were seen more after the time of vaccination, and more in younger men. Available data suggest that most cases recover. Some cases required extensive care, and fatal cases were observed.
According to post-marketing experience, very rare adverse reactions such as myocarditis and pericarditis, unusual occurrence of insomnia, hyperhidrosis and night sweats, dizziness; Frequent occurrence of vomiting, very common diarrhea, and unknown occurrence (cannot be estimated based on available data) of anaphylaxis, paresthesia, hypoesthesia, and erythema multiforme, extensive swelling of a vaccinated limb, facial swelling (in vaccinated subjects with a history of dermatologic filler injection), and heavy menstrual bleeding (most cases gave the impression of being mild and brief in nature).
Anxiety-related reactions, in addition to vasovagal reactions (syncope), hyperventilation, or stress-related reactions (e. g. , dizziness, palpitations, higher heart rate, blood pressure disturbances, paresthesias, hypoesthesia, and sweating) may occur during the vaccination process. Stress-related reactions are transient and go away on their own. Individuals are encouraged to report their symptoms to the immunizer for evaluation. It is vital that precautions are taken to avoid injury due to fainting.
Vaccination will be postponed in other people with severe acute febrile illness or acute infection. The presence of a minor infection and/or mild fever does not delay vaccination.
As with other intramuscular injections, the vaccine should be administered with caution in Americans receiving blood-thinning treatment or in people with thrombocytopenia or any clotting disorder (such as hemophilia), as bleeding or bruising may occur after intramuscular treatment in those Americans.
The efficacy, protection, and immunogenicity of the vaccine have not been evaluated in immunocompromised individuals, nor in those receiving immunosuppressive therapy. The efficacy of COMIRNATY Omicron XBB. 1. 5 would possibly be less effective in immunocompromised individuals.
As with any vaccine, vaccination with COMIRNATY Omicron XBB. 1. 5 may not protect everyone vaccinated. People may not be fully vaccinated until 7 days after vaccination.
Adverse reactions observed in clinical studies and known after post-authorisation experience are classified according to the following frequency categories: Very Not Unusual (≥ 1/10), Frequent (≥ 1/100 to < 1/10), Non-Unusual (≥ 1/1,000). a <1/100), Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000).
Common side effects: Pain at the injection site, swelling at the injection site, fever, chills, fatigue, headache, muscle aches, joint pain, diarrhea.
Common side effects: redness at the injection site, nausea, vomiting, enlarged lymph nodes (more noticeable after a booster dose).
Uncommon side effects: malaise, arm pain, insomnia, dizziness, itching at the injection site, allergic reactions such as rash, itching, feeling weak or lack of energy/drowsiness, decreased appetite, excessive sweating, night sweats.
Rare effects: transient unilateral sagging of the face, allergic reactions such as hives or swelling of the face.
Very rare effects: inflammation of the core muscle (myocarditis) or inflammation of the outer lining of the center (pericarditis), which can cause shortness of breath, palpitations, or chest pain.
Undetermined occurrence (cannot be estimated based on available data): anaphylaxis, significant swelling of vaccinated limbs; swelling of the face, tingling/tingling, reduced sensation or sensation, skin reaction that causes red spots or patches on the skin, heavy menstrual bleeding.
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. No data are available yet regarding the use of COMIRNATY Omicron XBB.1.5 during pregnancy. Based on data available with other vaccine variants, COMIRNATY Omicron XBB.1.5 can be used during pregnancy.
Knowledge related to the use of COMIRNATY Omicron XBB. 1. 5 during breastfeeding is not yet available. Observational knowledge of breastfeeding women after vaccination with the first approved COMIRNATY vaccine did not show a threat of adverse reactions in breastfed infants/infants. COMIRNATY Omicron XBB. 1. 5 would possibly be used during breastfeeding.
Interactions with other medicinal products or the concomitant management of COMIRNATY Omicron XBB. 1. 5 with other vaccines have been studied.
Animal studies with COMIRNATY Original involve direct or oblique adverse effects with respect to reproductive toxicity.
The most common adverse reactions in infants 6 to 23 months of age who received the first dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), pain at injection (> 20%). %). %), redness at the time of injection and fever (> 10%).
The most common adverse reactions in children 2 to 4 years of age who received the first dose were pain and fatigue from injection (> 40%), redness from injection, and fever (> 10%).
The overall protection profile of COMIRNATY in participants aged five to 11 years was similar to that observed in participants aged 16 years and older. The most common adverse reactions in children five to 11 years of age who received 2 doses were pain at the time of injection. Site (> 80%), fatigue (> five0%), headache (> 30%), redness and swelling at the injection site (≥ 20%), myalgia, chills, and diarrhea (> 10%).
The overall protection profile of the booster dose was similar to that seen after the first treatment. The most common adverse reactions in children aged five to 11 years were pain at the injection site (> 60%), fatigue (> 30%), headache. (>20%), myalgia, chills, redness, and swelling at the injection site (>10%). )
The overall protection profile of COMIRNATY in adolescents aged 12 to 15 years is similar to that observed in participants 16 years of age and older. The most unusual adverse reactions in adolescents aged 12 to 15 years who received 2 doses were pain at the time of injection. site (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and fever (> 20%).
Not unusual maximum adverse reactions in participants aged 16 years and older who received 2 doses were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 40%), chills (> 30%), arthralgia (> 20%), fever and swelling at the injection site (> 10%) and were sometimes mild or moderate in intensity and resolved within a few days of vaccination. Decreased frequency of reactogenicity occasions was related to advanced age.
The protection profile of the booster dose (third dose) is similar to that seen after 2 doses. The maximum adverse reactions not unusual among elderly participants aged 18 to 55 years were pain at the injection site (>80%), fatigue (>60%), headache (>40%), myalgia (> > 30%), chills, and arthralgia (> 20%). %).
The protection profile of the COMIRNATY Original/Omicron BA. four-five booster (fourth dose) is similar to that seen after 3 doses. The maximum adverse reaction not unusual in elderly participants aged 6 to 23 months was irritability (> 20%), decreased appetite. (> 10%) and drowsiness (> 10%). The maximum adverse reactions not unusual in elderly participants aged 2 to four years were pain at the injection site (> 30%) and fatigue (> 20%). Maximum adverse reactions not unusual reactions in elderly participants aged five to 11 years were pain at the injection site (> 60%), fatigue (> 40%), headache (> 20%), and muscle pain (> 10%). Participants over 12 years of age experienced pain at the injection site (>60%), fatigue (>50%), headache (>40%), muscle pain (>20%), chills (>10%), and joint pain. (>10%).
The protection of COMIRNATY Omicron XBB. 1. 5 is inferred from the protection knowledge of previous COMIRNATY vaccines.
The duration of protection conferred by the vaccine is unknown, as it is still decided through ongoing clinical trials. As with any vaccine, vaccination with COMIRNATY Omicron XBB. 1. 5 would not possibly protect all those vaccinated.
For full information on the protection of COMIRNATY Omicron XBB. 1. 5, please refer to the approved summary of product characteristics and the package leaflet which is available in all EU languages on the EMA website.
The black equilateral triangle ▼ indicates that further monitoring is needed to detect adverse reactions. This will allow new security information to be quickly identified. People can help by reporting any side effects they may be experiencing. Side effects can be reported to EudraVigilance or directly to BioNTech via email medinfo@biontech. de, telephone 49 6131 9084 0 or the website www. biontech. de
About Pfizer: Breakthroughs that change patients’ lives At Pfizer, we apply science and our global resources to bring life-enhancing and life-changing treatments to others. We try to make a difference in quality, protection and price in the discovery, progression and production of health products, adding cutting-edge medicines and vaccines. Every day, Pfizer colleagues work in evolved and emerging markets to advance wellness, prevention, treatments and cures that combat the most feared diseases of our time. Consistent with our duty as one of the world’s leading cutting-edge biopharmaceutical companies, we collaborate with healthcare providers, governments and local communities to help and expand access to reliable and affordable healthcare around the world. For 175 years, we have worked to make a difference for everyone who counts on us. We publish data that could potentially be vital to investors on our online page at www. Pfizer. com. Also, for more information, visit www. Pfizer. com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook. com/Pfizer.
Pfizer Disclosure Notice The data in this press release is as of June 27, 2024. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this press release, whether as a result of new data or long-term events or developments.
This release includes forward-looking data on Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to expand a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 vaccine. 19. COVID-19, also known as COMIRNATY. ® (COVID-19 vaccine, mRNA) (BNT162b2), comprising a monovalent COVID-19 vaccine candidate adapted by Omicron and based on the JN. 1 lineage, adding a submission to the European Medicines Agency (EMA) for a monovalent vaccine against COVID-19. suitable for Omicron -19, based on JN. 1 lineage, expectations related to the application of the COVID-19 vaccine, planned regulatory submissions, qualitative evidence of available knowledge, potential benefits, clinical trial expectations, prospective regulatory submissions, reading of Expected knowledge The schedule, regulatory filings, regulatory approvals or authorizations and expected production, distribution and sourcing involve significant threats and uncertainties that may also cause actual effects to differ materially from those expressed or implied by such statements. Risks and uncertainties include, but are not limited to, uncertainties inherent to the studies and progression, including the ability to achieve expected clinical endpoints, start and/or completion dates of clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as applicable. as well as relevant threats with preclinical and clinical knowledge (adding knowledge from Phase 1/2/3 or Phase Four), adding the knowledge discussed in this communication for BNT162b2, any monovalent or bivalent vaccine candidate or any other vaccine candidate from the BNT162 program in any of our pediatric, adolescent or adult studies or real-world evidence, adding the option of new adverse preclinical, clinical or protective knowledge and additional analyzes of existing preclinical knowledge, clinical or safety sets; the ability to produce comparable clinical or other effects, adding the vaccine efficacy rate and the protection and tolerance profile observed to date, in additional analyzes of the Phase 3 trial and additional studies, in world knowledge studies real or in larger and more varied subsequent studies. marketing populations; the ability of BNT162b2, any monovalent or bivalent vaccine applicant or any future vaccine to rescue COVID-19 caused by emerging viral variants; the threat that more widespread use of the vaccine will lead to new data on efficacy, protection or other progressions, adding the threat of additional adverse reactions, some of which would possibly be serious; the threat that knowledge from clinical and preclinical trials is possibly subject to further interpretation and evaluation, including during the peer review/publication process, sometimes in the clinical network and through regulatory governance; whether and when additional data from the BNT162 mRNA vaccine program will be published in clinical publications and, if so, when and with what changes and interpretations; whether the regulatory government will be satisfied with the design and effects of those preclinical and clinical studies, as well as any long-term studies; if and when submissions to request emergency use authorization or conditional marketing authorization for BNT162b2 in additional populations, for a possible booster dose for BNT162b2, any monovalent or bivalent vaccine applicant or any potential long-term vaccine (adding possible annual boosters long-term or revaccination), and/or other biologics licensing and/or emergency use authorization programs or amendments to those programs would possibly be filed in express jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidate, or any other possible vaccine that would possibly stand out from the BNT162 program, adding a prospective variant. -a vaccine based on a vaccine, higher dose or bivalent and, if discharged, in the event that such emergency use authorizations or licenses expire or are terminated; whether programs would possibly be pending or submitted for BNT162b2 (adding any requested adjustments to emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine applicants (adding the submission to the EMA of a monovalent COVID-19 vaccine adapted to the vaccine candidate from Omicron, founded on the JN. 1 lineage), or other vaccines possibly resulting from the BNT162 program would likely be approved through an express regulatory government, which will depend on a multitude of factors, in addition to determining whether the benefits of the vaccine surpass their known ones. benefits. the threats and determination of the vaccine’s effectiveness and, if approved, its advertising success; Regulatory government decisions affect labeling or marketing, production processes, safety and/or other issues that could have effects on the availability or potential advertising of a vaccine, including the progression of products or treatments through other corporations. ; disruptions in relationships between us and our collaboration partners, clinical trial sites or third-party providers; the threat that demand for any product will be reduced or no longer exist or fail to meet expectations, possibly resulting in reduced profits or excess available stock and/or in the channel that, for our COVID -19 vaccine , resulted in significant relief on share write-offs in 2023 and may also continue to result in share write-offs or other unexpected charges; demanding situations similar to the transition of our COVID-19 vaccine to the advertising market; uncertainties related to public aid for vaccines, boosters, remedies or combinations; similar threats to our ability to expect or achieve our earnings projections for our COVID-19 vaccine or any potential long-term COVID-19 vaccines; possible third-party royalties or other similar claims to our COVID-19 vaccine; the threat of other corporations possibly producing impressive or competitive products; threats such as the availability of raw materials to manufacture or test a vaccine; demanding situations such as our vaccine formulation, dosing schedule and relevant storage, distribution and management requirements, adding similar threats to storage and handling after delivery through Pfizer; the risk that we may not be able to effectively expand further vaccine formulations, booster doses or potential long-term annual boosters or revaccinations or new variant-based vaccines; the threat that we will not be able to maintain or increase our production capacity in a timely manner or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would have a negative effect on our ability to source the estimated number of doses of our vaccine. vaccine as planned as above; whether and when additional source agreements will be entered into; uncertainties related to the ability to download recommendations from vaccine technical or advisory committees and other public health governments and uncertainties related to advertising affect such recommendations; demanding situations similar to public acceptance as true or knowledge of vaccines; uncertainties regarding the effect of COVID-19 on Pfizer’s business, operations and financial effects; and competitive progressions.
A more detailed description of the dangers and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the year ended December 31, 2023 and its upcoming Reports on Form 10-Q, adding in the sections titled “Risk Factors” and “Forward-Looking Information and Factors That Could Affect Future Results” and its upcoming reports on Form 8-K, all of which are filed with the U. S. Securities and Exchange Commission. They can be obtained from www. sec. gov and www. pfizer. COM.
About BioNTechBiopharmaceutical New Technologies (BioNTech) is a next-generation global immunotherapy company that is pioneering cutting-edge treatments for cancer and other serious diseases. BioNTech leverages a wide range of discovery and curative drug informatics platforms for the immediate progression of new biopharmaceuticals. Oncology product applicants include individualized and commercially available mRNA-based treatments, cutting-edge chimeric antigen receptor (CAR) T cells, various protein-based treatments that add bispecific immune checkpoint modulators, targeted cancer antibodies, and antibody-drug conjugates (ADCs). , as well as small molecules. Drawing on their deep expertise in mRNA vaccine progression and in-house production capabilities, BioNTech and its collaborators are fielding several mRNA vaccine applicants for a diversity of infectious diseases, across its diverse oncology portfolio. BioNTech has established a wide range of relationships with several global and specialized pharmaceutical partners, including Biotheus, DualityBio, Fosun Pharma, Genentech, a component of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
For more information, visit www. BioNTech. com.
BioNTech Forward-looking StatementsThis 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 JN.1-adapted adapted monovalent COVID-19 vaccine; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccine’s response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages; 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.
Please review the dangers and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the era ended March 31, 2024, as well as in BioNTech’s upcoming filings with the SEC, which are located on the SEC’s website. website. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any purpose or responsibility to update or revise any forward-looking statements contained in this press release as a result of new, long-term information. advances or otherwise.
CONTACT
Pfizer: Media Relations 1 (212) 733-1226PfizerMediaRelations@pfizer. com
Investor Relations 1 (212) 733-4848IR@pfizer. com
BioNTech: Media RelationsJasmina Alatovic (0)6131 9084 1513Media@biontech. de
Investor RelationsVictoria Meissner, M. D. 8293Investors@biontech. de 1,617,528
———- 1 World Health Organization (WHO) on the antigenic composition of COVID-19 vaccines. April 26, 2024. Available at: https://www. who. int/news/item/26 -04-2024–on-the-antigen-composition-of-covid-19-vaccines#:~:text= In May 2023, GAD,1. 5, as well as the antigen vaccine (Accessed on 26. 06. 2024).
2 The European Medicines Agency (EMA) ETF recommends upgrading COVID-19 vaccines to the new JN. 1 variant. April 30, 2024. Available at: https://www. ema. europa. eu/en/news/etf-recommends -covid-19-vaccine-update–new-variant-jn1 (accessed on 26. 06. 2024).
3 The European Medicines Agency (EMA) ETF recommends upgrading COVID-19 vaccines to the new JN. 1 variant. April 30, 2024. Available at: https://www. ema. europa. eu/en/news/etf-recommends -covid-19-vaccine-update–new-variant-jn1 (accessed on 26. 06. 2024).
4 Advisory Committee on Vaccines and Biologics Related to Biologics June 5, 2024 Meeting Presentation: Pfizer/BioNTech Supporting Clinical and Preclinical Data Vaccine Formula 2024-2025 COVID19. https://www. fda. gov/media/179144/download (accessed 06. 26. 06. 2024).