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CHMP advice on favorable knowledge of vaccines adapted to Omicron
The bivalent COVID-19 booster vaccine Omicron BA. 4/BA. 5 combines 15 μg of mRNA encoding the wild-type sars-CoV-2 spike protein in the Pfizer-BioNTech COVID-19 vaccine and 15 μg of mRNA encoding omicron BA. Subvariant tip protein 4/BA. 5
The bivalent Pfizer-BioNTech Omicron BA. 4/BA. 5 COVID-19 vaccine will be sent immediately, pending approval by the European Commission, to EU vaccination campaigns this autumn.
NEW YORK and MAINZ, GERMANY, September 12, 2022: Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30 μg booster dose of their bivalent Omicron BA. 4/BA. 5 adapted COVID-19 (COMIRNATY® Original/Omicron BA. 4/BA. 5 15/15 μg) has been advised for conditional marketing authorisation (CMA) through the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Elderly (EMA) 12 years of age or older. The European Commission will advise the CHMP and is expected to take a final decision shortly.
The adapted bivalent vaccine Omicron BA. 4/BA. 5 15 μg of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the original Pfizer-BioNTech COVID-19 vaccine, and 15 μg of mRNA encoding the tip protein of the Omicron BA. 4/BA. 5 subvariants. Except for the addition of the mRNA series of the BA. 4/BA. 5 spike protein, all other parts of the vaccine remain unchanged.
“This advice marks a major milestone in the ongoing global fight against COVID-19, strengthening our defenses as we prepare for fall and winter with increased potential exposure to the virus,” said Albert Bourla, president and chief executive officer of Pfizer. Because of our multifaceted system to help address emerging and subvariant variants of interest, the EU public health government will have our bivalent booster options, pending authorization, to facilitate flexible vaccination methods for maximum policy in the region. “
“If the European Commission follows today’s chmp recommendation, EU citizens will have to be vaccinated with omicrons before the winter season begins,” said Professor Ugur Sahin, M. D. , CEO and co-founder of BioNTech. “Bivalent vaccines code for the wild-type spike protein of SARS-CoV-2, as well as a spike protein of an Omicron subvariant. It aims to provide a broader immunization against COVID-19 caused by the existing dominant sublines of Omicron and earlier variants of concern.
Today’s advice follows the direction of the EMA, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) to advance applicants for bivalent vaccines with the goal of making a suitable vaccine for Omicron. for the member states of the European Union. European Union (EU) as soon as possible. as possible. The CHMP advice for the bivalent COVID-19 Omicron BA. 4/BA. 5 vaccine is based on knowledge of the adapted bivalent vaccine Omicron BA. 1 from Pfizer and BioNTech, as well as preclinical and production knowledge of the Omicron BAArray4 / Adapted bivalent vaccine BA . 5. Clinical insight from a Phase 2/3 trial showed that a booster dose of the adapted bivalent vaccine Omicron BA. 1 from Pfizer and BioNTech elicited a striking opposite immune reaction to the Omicron BA. 1 subvariant compared to COVID-19 companies existing. vaccine, with a favorable protection profile. In addition, preclinical knowledge showed that a booster dose of the adapted BA. 4/BA. 5 bivalent vaccine elicited a strong neutralizing antibody reaction opposite to the Omicron sublines, adding subvariants BA. 1. Array BA. 2, BA . 4 and BA. 5 . Array as well as the original virus, maintaining a favorable protection profile.
If an authorisation is granted, the bivalent Pfizer-BioNTech Omicron BA. 4/BA. 5 COVID-19 vaccine will be available in the coming days for the 27 EU Member States supporting European vaccination campaigns. the demands of the government of each country. In early September, Pfizer and BioNTech received conditional marketing authorization for an Omicron BA. 1 adapted bivalent COVID-19 vaccine in the EU. An Omicron-adapted vaccine based on BA. 4/BA. 5 the subvariant is also legal through the U. S. Food and Drug Administration. U. S. As a Booster for Ages 12 and up on Aug. 31, 2022. The companies also plan to register the data with other regulatory authorities in the coming weeks and plan to submit the data to the FDA and EMA to prepare an application for a bivalent vaccine suitable for Omicron in children under the age of 12.
The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed through BioNTech and Pfizer. BioNTech holds the marketing authorization of BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and holds emergency use authorizations or equivalent in the United States (jointly with Pfizer) and other países. de countries. Submissions are planned to continue regulatory approvals in countries where emergency use authorizations or equivalent were first granted.
AUTHORIZED USE IN THE EU: COMIRNATY® ▼ (the Pfizer-BioNTech COVID-19 vaccine) has obtained a Conditional Marketing Authorization (CMA) from the European Commission to prevent coronavirus disease 2019 (COVID-19) in other people over the age of five years and older. The vaccine is given in a series of 2 doses, 3 weeks apart. Adults and adolescents 12 years of age and older get 30 micrograms based on dose; children older than five to 11 years get 10 micrograms according to the dose. In addition, the CMA was expanded to include a booster dose (third dose) at least three months after the current dose in other persons 12 years of age and older. A third dose of course number one may be given at least 28 days after the current dose to others five years of age or older whose immune makeup is severely compromised. 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 sufficiently physically powerful knowledge is already available on the quality, protection and efficacy of the vaccine.
In addition, COMIRNATY also received cMA as a suitable vaccine called COMIRNATY Original/Omicron BA. 1, comprising mRNA encoding the wild-type spike protein and the subvariant omicron BA. 1 of SARS-CoV-2. COMIRNATY Original/Omicron BA. 1 may be given as a booster in others 12 years of age and older who have obtained at least one VACCINATION number one for COVID-19. There will need to be a period of at least 3 months between the handling of COMIRNATY Original/Omicron BA. 1 and the last past dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION:
Cases of anaphylaxis have been reported. Appropriate medical treatment and follow-up should be available in case of an anaphylactic reaction after treatment with the vaccine.
There is a major but very rare threat (<1/10,000 cases) of myocarditis and pericarditis after vaccination with COMIRNATY®. These situations can spread within a few days after vaccination and have basically occurred within 14 days. They were seen more after the time of vaccination, and more in young men. The knowledge to take into account recommends that the course of myocarditis and pericarditis after vaccination is none other than that of myocarditis or pericarditis in general. The threat of myocarditis after a booster dose of COMIRNATY or COMIRNATY Original/Omicron BA . 1 has not yet been characterized.
Rare cases of acute peripheral facial paralysis; unusual onset of insomnia, hyperhidrosis and night sweats; and an unknown occurrence of paresthesia, hypoesthesia and erythema multiforme known after marketing.
Anxiety-related reactions, adding vasovagal reactions (syncope), hyperventilation, or stress-related reactions (p. e. g. , dizziness, palpitations, immediate heart rate, changes in blood pressure, tingling sensations and sweating) may occur according to the vaccination procedure Stress-related reactions are transient and go away on their own. People are asked to report symptoms to the vaccinator for evaluation. It is vital that precautions are taken to avoid injuries caused by fainting.
Vaccination will be postponed in other people with severe acute febrile illness or acute infection. The presence of a mild infection and/or low fever does not delay vaccination.
As with other intramuscular injections, the vaccine should be given with caution in other people receiving anticoagulant treatment or who have thrombocytopenia or any other bleeding disorder (such as hemophilia), as bleeding or bruising may occur after intramuscular treatment in those other people.
The efficacy, protection and immunogenicity of the vaccine have not been evaluated in immunocompromised individuals, adding those receiving immunosuppressive therapy. The efficacy of COMIRNATY or COMIRNATY Original/Omicron BA. 1 would possibly be decreased in immunocompromised individuals.
As with any vaccine, vaccination with COMIRNATY or COMIRNATY Original/Omicron BA. 1 may not protect all vaccine recipients. People may not be fully vaccinated until 7 days after the current dose of vaccine.
Adverse reactions observed in clinical studies are classified according to the following frequency categories: Very unusual (≥ 1/10), Common (≥ 1/100 to < 1/10), Non-unusual (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very uncommon (< 1/10,000).
Very common side effects: pain at the injection site, swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, diarrhea, fever
Common effects: redness at the injection site, nausea, vomiting
Uncommon side effects: swollen lymph nodes (most noticed after the booster dose), discomfort, arm pain, insomnia, itching at the injection site, allergic reactions such as rash or itching, weakness or lack of energy/drowsiness, decreased appetite, sweating, night sweats
Rare effects: transient unilateral facial sagging, allergic reactions such as hives or swelling of the face
Very rare appearance effects: inflammation of the core muscle (myocarditis) or inflammation of the outer lining of the core (pericarditis), which may lead to shortness of breath, palpitations or chest pain, anaphylaxis, swelling of the vaccinated limbs; facial swelling, tingling/pins and needles, decreased sense of touch or sensation, skin reaction causing red spots or patches on the skin
A large amount of observational data from pregnant women vaccinated with the COMIRNATY vaccine first approved the timing and the third trimester did not show a backlog of adverse pregnancy outcomes. Although data on pregnancy outcomes after vaccination in the first trimester are limited recently, no accumulation of risk of miscarriage has been observed. COMIRNATY can be used during pregnancy. No effects are expected on the breastfed newborn/baby, as the lactating woman’s systemic exposure to the first of all COMIRNATY-approved vaccines is negligible. . COMIRNATY can be used during lactation.
There is not yet any knowledge regarding the use of COMIRNATY Original/Omicron BA. 1 pregnancy. Since the differences between the products are limited to the spike protein series and there are no clinically significant differences in reactogenicity between vaccines adapted to COMIRNATY variants that have been clinically evaluated, COMIRNATY Original/Omicron BA. 1 can be used during pregnancy.
The use of COMIRNATY Original/Omicron BA. 1 lactation is not yet known. Observational knowledge of women who breastfed after being vaccinated with the first of all approved COMIRNATY vaccines did not show a threat of adverse events in breastfed infants/infants. . COMIRNATY Original/Omicron BA. 1 can be used while breastfeeding
Interactions with other medicinal products or concomitant management of COMIRNATY or COMIRNATY Original/Omicron BA. 1 with other vaccines have been studied.
Animal studies involve direct or oblique adverse effects with respect to reproductive toxicity.
The protection of a booster dose of COMIRNATY Original/Omicron BA. 1 in people aged 18 to ≤ 55 years is extrapolated from the protective knowledge of a subset of 315 adults aged 18 to ≤ 55 years who gained a booster dose (fourth dose) of Omicron BA . 1 30 μg (monovalent) after supplementing 3 doses of COMIRNATY. The non-unusual maximum adverse reactions in participants aged 18 to ≤ 55 years were injection pain (> 70%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills (> 30%), and arthralgia (> 20%).
In a subset of the Phase 3 study, 305 adults over the age of 55 who gained 3 doses of COMIRNATY obtained a recall of COMIRNATY Original/Omicron BA. 1 after receiving dose 3. The general protection profile of COMIRNATY Original/Omicron The BA. 1 withdrawal (fourth dose) similar to that observed after withdrawal of COMIRNATY (third dose). The maximum non-unusual adverse reactions in participants older than 55 years were pain at the injection site (> 50%), fatigue (> 40%). , headache 69 (> 30 %), myalgia (> 20 %), chills and arthralgia (> ten %). No new adverse reactions were known for COMIRNATY Original/Omicron BA. 1.
The duration of protection presented through the vaccine is unknown, as it has still been decided through ongoing clinical trials. As with any vaccine, vaccination with Comirnaty Original/Omicron BA. 1 may not protect all vaccine recipients.
For complete information on the protection of COMIRNATY and COMIRNATY Original/Omicron BA. 1, please refer to the approved summary of product characteristics and package leaflet found in all EU languages on the EMA website.
The black equilateral triangle ▼ indicates that more follow-up is needed to detect any adverse effects. This will allow new security data to be known quickly. People can help by reporting any side effects they may experience. Side effects can be reported to EudraVigilancemedinfo@ biontech. de www. biontech. com or directly to BioNTech’s email, phone 49 6131 9084 0 or website.
About Pfizer: Advances That Replace Patients’ Lives We try to establish the popular in quality, protection, and price in the discovery, progression, and manufacture of healthcare products, adding cutting-edge drugs and vaccines. Every day, Pfizer colleagues work in developed and emerging markets to promote wellness, prevention, remedies, and cures that challenge the most feared diseases of our time. In keeping 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 over 170 years, we have worked to make a difference for everyone who relies on us. We publish data that would possibly be vital for investors on our online page at www. Pfizer. COM. Also, to receive more information, visit us at 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’s Disclosure Notice The data in this press release is dated September 12, 2022. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this press release 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 vaccine against COVID-19, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID vaccine. -19, also known as COMIRNATY ® (COVID-19 vaccine, mRNA) (BNT162b2) (adding an Omicron adapted bivalent vaccine candidate, based on the BA. four/BA. 5 subvariants, and a bivalent COVID-19 vaccine candidate Omicron-adapted, based on the BA. 1 subvariant, adding a pending submission to the EMA, for an Omicron-adapted bivalent vaccine candidate, based on the BA. four/BA. 5Array subvariants expected regulatory submissions, qualitative evidence of knowledge prospective benefits, clinical trial expectations, prospective regulatory filings, expected timing of knowledge readings, regulatory filings, regulatory approvals or authorizations, and expected production, distribution, and source) that involve genuinely extensive threats and uncertainties that may also cause actual effects to differ materially from those expressed or implied through such statements. Risks and uncertainties include, but are not limited to, uncertainties inherent to studies and progression, including the ability to achieve expected clinical endpoints, clinical trial graduation and/or completion dates, regulatory filing dates, regulatory approval and/or publication dates. , and relevant threats with preclinical and clinical knowledge (add Phase 1/2/3 or Phase four knowledge), add knowledge discussed in this release for BNT162b2, any monovalent, bivalent, or variant-adapted vaccine candidate or any other candidate vaccine in 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 studies of existing preclinical, clinical, or protective knowledge; the ability to produce comparable clinical or other effects, adding the efficacy rate of the vaccine and the profile of protection and tolerability observed to date, in additional analyzes of the Phase 3 trial and additional studies, in knowledge studies genuine or in larger and more varied post-market populations; the ability of BNT162b2, any monovalent, bivalent, or variant-matched vaccine applicant, or any long-term vaccine to protect you from 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 effects, some of which could potentially be serious; the threat of pre-clinical and clinical trial knowledge being subject to different interpretations and evidence, aggregated during the publication/peer-review process, in the wider clinical network and through regulatory government; whether and when additional knowledge of the BNT162 mRNA vaccine program will be published in clinical journals and, if so, when and with what modifications and interpretations; whether the regulatory government will be satisfied with the design and effects of such preclinical and long-term clinical studies; if and when submissions to seek emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine applicant, or any potential long-term vaccine (adding potential annual boosters or revaccination), and/or other biologics licensing and/or emergency use authorization programs or amendments to such programs would potentially be introduced in jurisdictions specific to BNT162b2, any monovalent or bivalent vaccine candidate, or other prospective vaccine that would possibly stand out from the BNT162 program, adding a prospective higher dose vaccine or bivalent variant, and if downloaded, whether such authorizations or emergency use licenses will expire or be cancelled; if and when any schedules that would potentially be pending or submitted for BNT162b2 (adding any emergency use replacement schedules or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (adding pending submission to EMA for a COVID vaccine candidate -19, based on subvariants BA. 4/BA. 5), or other vaccines that could result from the BNT162 program would potentially be approved by a specific regulatory government, which will rely on a myriad of factors, including determining whether the benefits of the vaccine outweigh their known threats and find out how effective the vaccine will be and, if approved, whether it will be a boon; regulatory government decisions have an effect on labeling or marketing, production processes, protection, and/or other issues that could affect the availability or potential publicity of a vaccine, as well as the progression of products or treatments through from other companies; interruptions in appointments between us and our collaboration partners, clinical trial sites or third-party providers; the threat that demand for any product will decrease or cease to exist, possibly resulting in reduced profits or excess inventory; similar threats to the availability of raw fabrics to make a vaccine; challenging situations with our vaccine formulation, dosing schedule, and storage, distribution, and handling requirements, adding relevant threats with Pfizer’s post-delivery storage and handling; the threat that we may not be able to happily expand preferred vaccine formulations, booster doses or potential long-term annual boosters or revaccinations or new next-generation or variant-based vaccines; the risk that we may not be able to maintain or develop production capacity in a timely manner or maintain access to logistics or source channels commensurate with global demand for our vaccine, which would negatively affect our ability to deliver the estimated number of doses of our vaccine on schedule, as reported in the past; if and when additional source agreements will be signed; uncertainties related to the ability to download recommendations from vaccine technical or advisory committees and other public fitness governments and uncertainties related to advertising have an effect on such recommendations; require situations similar to those that the public accepts as true or knowledge of vaccines; uncertainties related to the influence of COVID-19 on Pfizer’s business, operations and monetary effects; and competitive progressions.
A more detailed description of the hazards and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the year ended December 31, 2021 and in its upcoming reports on Form 10-Q, adding the sections thereof titled “Risk Factors. “and “Forward-Looking Information and Factors That Could Affect Future Results,” and in its upcoming reports on Form 8-K, all of which are filed with the U. S. Securities and Exchange Commission. They are located in www. sec. gov and www. pfizer. com.
About BioNTech Biopharmaceutical New Technologies is a next-generation immunotherapy company pioneering novel treatments for cancer and other serious diseases. The company operates a wide diversity of computational discovery and curative drug platforms for the immediate progression of new biopharmaceuticals. Its broad portfolio of oncology product applicants includes ready-to-use, individualized mRNA therapies, next-generation chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted anticancer antibodies, and small molecules. Building on its deep experience in mRNA vaccine progression and in-house production capabilities, BioNTech and its collaborators are submitting multiple applicants for mRNA vaccines for a variety of infectious diseases across its diverse oncology portfolio. BioNTech has established a wide variety of relationships with several global pharmaceutical partners, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer. For more information, visit www. BioNTech. com. Forward-Looking Statements by BioNTech This press release comprises “forward-looking statements” by BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements would possibly include, but are not limited to, statements Related to: BioNTech’s efforts to fight COVID-19; the collaboration between BioNTech and Pfizer comprising the COVID-19 vaccine progression program and COMIRNATY® (COVID-19 vaccine, mRNA) (BNT162b2) (which adds an Omicron-adapted bivalent COVID-19 vaccine candidate based on BAs. 1 and BAArrayfour/BA. 5 subvariants, expected regulatory filings, qualitative evidence of available knowledge, prospective benefits, clinical trial expectations, expected schedule of regulatory filings, regulatory approvals or clearances, and expected production, distribution, and source); our expectations regarding the prospective characteristics of BNT162b2, any monovalent or bivalent vaccine applicant, or any long-term vaccine, in our clinical trials and/or advertising use based on observations of knowledge to date; the ability of BNT162b2, any monovalent or bivalent vaccine applicant, or any long-term vaccine, to protect you from COVID-19 caused by emerging viral variants; uncertainties inherent in studies and progression, adding the ability to achieve expected clinical endpoints, clinical trial start and/or end dates, regulatory filing dates, regulatory approval dates, and/or end dates. launch, as well as the relevant threats with preclinical and clinical. knowledge (add Phase 1/2/3 or Phase four knowledge), add knowledge discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidate, or any other candidate vaccine in the BNT162 schedule in any of our pediatric, adolescent, or adult studies o Real-world evidence, adding the option of new adverse preclinical, clinical, or protective knowledge and further analyzes of existing preclinical, clinical, or protective knowledge; the expected timing of further reading regarding knowledge of the efficacy of BNT162b2, any monovalent or bivalent vaccine applicant, or any long-term vaccine, in our clinical trials; 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 effects, some of which could potentially be serious; the nature of clinical knowledge, which is subject to ongoing peer review, regulatory review, and market interpretation; the time of submission of the bill or receipt of any market placement approval or emergency use authorization; our proposed shipping and garage plan, adding the estimated shelf life of our products at other temperatures; BioNTech’s ability to source quantities of BNT162, any monovalent or bivalent vaccine applicant, or any long-term vaccine, to aid clinical progression and market demand, adding our production estimates for 2022; that demand for any product could be reduced or cease to exist, which could result in reduced profits or excess inventory; the availability of raw tissues to make a vaccine; the formulation, dosing schedule, and storage, distribution, and management needs of our vaccines, adding relevant threats with storage and post-delivery handling through Pfizer; the ability to either expand vaccine formulations of choice, booster doses or possible long-term annual boosters or revaccinations or new variant-based vaccines; the ability to maintain or develop production capacity in a timely manner or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would adversely affect our ability to obtain the estimated number of doses of our vaccine within the expected time frame as stated above; if and when additional source agreements will be signed; the ability to download recommendations from vaccine technical or advisory committees and other publicly available governments and uncertainties related to the announcement have an effect on such recommendations; require situations similar to those that the public accepts as true or knowledge of vaccines; and uncertainties related to the effect of COVID-19 on BioNTech’s trials, business and general operations. All forward-looking statements contained in this press release are based on BioNTech’s existing expectations and ideals regarding long-term events and are subject to a number of threats and uncertainties that may also cause actual effects to differ materially and adversely from those stated or implied by such statements. – look at the statements. These threats and uncertainties include, but are not limited to: the ability to achieve predefined endpoints in clinical trials; festival to create a vaccine against COVID-19; the ability to produce clinical or other comparable effects, adding our reported rate of vaccine efficacy and protection and tolerance profile observed to date, in the remainder of the trial, or in a larger and more diversified one when placed in the market; the ability to scale well our production capabilities; and other prospective difficulties. For a discussion of those and other threats and uncertainties, see BioNTech’s Quarterly Report on Form 6-K for the quarter ended June 30, 2022, filed with the SEC on August 8, 2022, located at the SEC’s online page. online page at www. sec. gov. All data contained in this press release is as of the date of publication, and BioNTech assumes no legal responsibility to update this data, unless required by law.
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