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CHMP advice on safety, tolerability and immunogenicity knowledge from a phase 2/3 trial of the adapted bivalent vaccine Omicron BA. 1
The bivalent COVID-19 vaccine adapted to Omicron BA. 1 combines 15 μg of mRNA encoding the wild-type spike protein SARS-CoV-2 discovered in the original Pfizer-BioNTech COVID-19 vaccine with 15 μg of mRNA encoding the peak protein of the Omicron BA variant. 1
The adapted bivalent vaccine Omicron BA. 1 is available for immediate shipment at the start of European vaccination campaigns in the coming days
NEW YORK and MAINZ, GERMANY, September 1, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30 μg booster dose of their Omicron BA. 1- Bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA. 1 15/15 μg) has been recommended for Conditional Marketing Authorisation (cMA) through the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for people aged 12 years and older. The Commission will advise the CHMP and is expected to adopt a final decision shortly.
The adapted bivalent vaccine Omicron BA. 1 15 μg of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is provided in the original Pfizer-BioNTech COVID-19 vaccine, and 15 μg of mRNA encoding the tip protein of the subvariant Omicron BA. 1. Apart from the addition of the mRNA series of the BA. 1 spike protein, all other parts of the vaccine remain unchanged.
“As we face the fall living with COVID-19, our bivalent vaccine tailored to Omicron BA. 1 provides EU residents, physical care providers and public health government with a quick way to start increasing Immunity to Omicron, pending approval,” said Albert Bourla, President and CEO of Pfizer. “It has been clinically demonstrated that this bivalent vaccine adapted to ba. 1 has a favorable protection profile with immunogenicity as opposed to wild-type and Omicron-like strains and may serve as a key component of vaccination methods for the coming months. “
“Today’s positive opinion through the Committee confirms that the immunogenicity and protection objectives of variant-adapted mRNA vaccines can be achieved. Compared to a booster dose of our COVID-19 vaccine, which was recently approved for use in the EU, the bivalent mRNA vaccine encodes wild-type proteins and the ba. 1 spike protein provides higher neutralizing antibody titers than Omicron BA. 1 and BA. 4/BA. 5 sublines,” said Professor Ugur Sahin, M. D. , CEO and co-founder of BioNTech. “In addition, a booster dose of our adapted bivalent Omicron BA. 1 vaccine is expected to maintain and expand the diversity of B and T mobile responses to provide broader immunity to COVID-19 through SARS-CoV-2, adding omicron sublines.
Today’s council follows the direction of the EMA, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) to advance a bivalent vaccine candidate, with the aim of making a vaccine tailored to Omicron for the European Union (EU) member states. As soon as possible.
The CHMP’s advice is based on previously announced knowledge of protection, tolerability and immunogenicity from a phase 2/3 trial of participants over the age of 56 who gained a 30 μg booster dose of the adapted bivalent vaccine Omicron BA. 1. In this study, a booster dose of the adapted bivalent vaccine Omicron BA. 1 (n = 178) elicited an impressive immune reaction opposite to the subvariant Omicron BA. 1 compared to the companies’ original COVID-1nine vaccine (n = 163), as demonstrated through an approximately nine-fold improvement in neutralization titers. In further analyses of a live SARS-CoV-2 virus neutralization test verified in the sera of participants in this trial, neutralization titers advanced approximately fourfold for BA. cuatro/BA. 5 (n = 100). The bivalent vaccine adapted to BA. 1 was well tolerated with a favorable protection profile.
If an authorisation is granted, doses of COMIRNATY® Original/Omicron BA. 1 will be available in the coming days in the 27 EU Member States supporting the launch of European vaccination campaigns. Local supply will possibly vary depending on the demands of each country’s government.
The companies also submitted an application to the EMA for a booster dose of a bivalent COVID-19 vaccine adapted to Omicron BA. 4/BA. 5 to enable flexible vaccination strategies. This application is recently under review. An Omicron-adapted vaccine based on the legal subvariant BA. 4/BA. 5 through the U. S. Food and Drug Administration. U. S. As a Booster for Ages 12 and up on Aug. 31, 2022.
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.
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 an increased but very rare risk (<1/10,000 cases) of myocarditis and pericarditis after vaccination with COMIRNATY. These situations can extend a few days after vaccination and have basically occurred within 14 days. They were seen more after vaccination time, and more in young men. The knowledge we have 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 3rd dose of COMIRNATY 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 would possibly be decreased in immunocompromised individuals.
As with any vaccine, COMIRNATY vaccination would not protect all vaccinated. People would not be fully vaccinated until 7 days after the current dose of the vaccine.
In clinical studies, adverse reactions in participants older than 16 years who received two doses were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%). ), arthralgia (> 20%), pyrexia and swelling at the injection site (> 10%) and were sometimes of mild or moderate intensity and disappeared within days of vaccination. A decrease in the frequency of reactogenicity occasions was related to age.
The overall protective profile of COMIRNATY in participants older than five to 15 years who received two doses similar to that seen in participants older than 16 years. The maximum non-unusual side effects in children older than five to 11 years were pain at the injection site (> 80%), fatigue (> 50%), headache (> 30%), redness and swelling at the injection site (> 20%), myalgia, and chills (> 10%).
A large amount of observational data from pregnant women vaccinated with COMIRNATY at the time and in the third trimester did not show a cumulative of adverse pregnancy outcomes. Although data on pregnancy outcomes after vaccination in the first trimester are limited recently, no risk of miscarriage has accumulated. has been observed. COMIRNATY can be used during pregnancy. No effects on the breastfed newborn/baby are expected as the lactating woman’s systemic exposure to COMIRNATY is negligible. Observational knowledge of women who breastfed after vaccination did not show a threat of adverse events in breastfed infants/infants. COMIRNATY can be used during lactation.
Interactions with other medicinal products or concomitant management of COMIRNATY with other vaccines have been studied.
Animal studies involve direct or oblique adverse effects with respect to reproductive toxicity.
For complete information on the protection of COMIRNATY, 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: Life-Changing Advances we try to establish the popular in quality, protection, and price in the discovery, progression, and production of healthcare products, adding cutting-edge drugs and vaccines. Every day, Pfizer colleagues work in developed and emerging markets to promote wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. In keeping with our duty as one of the world’s leading leading biopharmaceutical companies, we work with healthcare providers, governments and local communities to help and expand access to reliable and affordable healthcare around the world. For more than 170 years, we have painted to make a difference for everyone who counts on us. We published data that would possibly be vital for investors on our online page at www. Pfizer. com. Also, to receive more information, visit us on www. Pfizer. com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook. com/Pfizer.
Pfizer Disclosure Notice
The data contained in this press release is dated September 1, 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 COVID-19 vaccine candidate based on the BA. 1 subvariant, and an Omicron-adapted bivalent vaccine candidate, based on BA . four/BA. 5 subvariants, adding pending EMA submissions, planned regulatory submissions, qualitative evidence of available knowledge, potential benefits, clinical trial expectations, prospective regulatory submissions, expected timing of data reads, regulatory submissions, regulatory approvals or clearances, and expected production, distribution and supply) involving genuinely extensive threats and uncertainties that may also cause genuine effects to differ materially from those expressed or implied through this statement. 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 suitable monovalent, bivalent or variant vaccine candidate or any other vaccine candidate 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 other analyzes 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 more 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 further 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 apply for conditional or emergency use marketing authorizations for BNT162b2 in other 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 potentially pending or submitted schedules for BNT162b2 (adding any emergency use replacement schedules or conditional marketing authorizations), any monovalent or bivalent vaccine applicants (adding pending submissions to the EMA for a bivalent COVID-19 Omicron-adapted vaccine candidate, based on the BA. 1 subvariant, and an Omicron-adapted bivalent COVID-19 candidate vaccine, based on the BA. 4/BA. 5 subvariants), or other vaccines that would possibly result from the BNT162 program possibly they would be approved by a specific regulatory government, which will take into account a myriad of factors, including whether the vaccine’s benefits outweigh its known threats and determining the vaccine’s efficacy and, if approved, whether it will be a publicity blockbuster; 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 effectively 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 new source agreements will be entered into; 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 BioNTechBiopharmaceutical New Technologies is a next-generation immunotherapy company, pioneering new treatments against cancer and other serious diseases. The company operates a wide variety of computational discovery platforms and curative drugs for the immediate progression of new biopharmaceuticals. Its broad portfolio of oncology products Applicants include individualized, out-of-the-box mRNA-based treatments, state-of-the-art chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted anticancer antibodies, and small molecules. Based on their deep expertise in mRNA vaccine progression and in-house production capabilities, BioNTech and its collaborators are submitting several mRNA vaccine applicants for a variety of infectious diseases throughout their varied oncology portfolio. BioNTech has established a wide diversity of relationships with several global pharmaceutical collaborators, adding Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Gene vant, 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 combat COVID-19; the collaboration between BioNTech and Pfizer comprising the COVID-19 vaccine progression program and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (adding an Omicron-adapted bivalent COVID-19 vaccine candidate based on BA. 1 and BA. four/ BA. 5, expected regulatory filings, qualitative evidence of available knowledge, prospective benefits, clinical trial expectations, expected schedule of regulatory filings, regulatory approvals or clearances, and production, planned 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 forward-looking 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 comparable clinical or other effects, adding our reported rate of vaccine efficacy and protection and tolerance profile observed to date, in the remainder of the trial, or in larger and more diversified when marketed; the ability to scale well our production capabilities; and other prospective difficulties.
For a discussion of those and other dangers and uncertainties, see BioNTech’s quarterly report, Form 6-K, for the quarter ended June 30, 2022, filed with the SEC on August 8, 2022, which is located on the SEC’s online page at www. . sec. gov. All information contained in this press release is valid as of the date of publication, and BioNTech assumes no legal responsibility to update such information, as required by law.
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