NEW YORK and MAINZ, Germany, Oct. 19, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has marketing authorisation (MA) for a 3 μg dose of COMIRNATY® (COVID-19 vaccine, mRNA), which is based on the SARS-CoV-2 wild spike protein, in a series of 3 doses for children 6 years to less than five years of age (also called 6 months to four years of age). The European Commission will review the CHMP advice and is expected to make a final ruling shortly.
Today’s advice is based on knowledge from a phase 2/3 randomized controlled trial that included 4526 children aged 6 months to less than five years. In the trial, children gained a third 3 μg dose of the original Pfizer-BioNTech COVID-19 vaccine at least two months after the time of dose at a time when Omicron BA. 2 is the primary variant. After the third dose in this age group, the companies’ original COVID-19 vaccine is 73. 2% effective (95% bilateral CI: 43. 8%, 87. 6%) in preventing COVID-19, with a favorable protection profile similar to placebo. The 3 μg dose was consciously decided as the preferred dose for children under five years of age based on protection, tolerability and immunogenicity.
The U. S. Food and Drug AdministrationThe U. S. Food and Drug Administration (FDA) granted the Emergency Use Authorization (EUA) for the original Pfizer-BioNTech COVID-19 vaccine as a 3 3 μg dose series in this age organization in June 2022. Submissions to regulators around the world are ongoing. .
Pfizer and BioNTech are also in talks with the fitness government regarding a regulatory pathway for the possible authorization of their adapted bivalent COVID-19 vaccine Omicron BA. 4/BA. five for use in children under five. A pediatric phase 1/2/3 study initiated in September 2022 to compare other dosing regimens and dose levels of the adapted bivalent COVID-19 vaccine Omicron BA. 4/BA. five across all age groups.
COMIRNATY and its adapted vaccine variants (COMIRNATY Original/Omicron BA. 1 and COMIRNATY®®® Original/Omicron BA. 4-5) are based on BioNTech’s proprietary mRNA generation and were developed through BioNTech and Pfizer. BioNTech has marketing authorization in the United States, the European Union, the United Kingdom, Canada and holds emergency use authorizations or equivalent in the United States (along with Pfizer) and other countries. Submissions for regulatory approvals are expected in countries where emergency use authorizations or equivalent were first granted.
About the Pediatric Phase 1/2/3 Trial for the Original Pfizer-BioNTech COVID-19 Vaccine United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. The trial evaluated the safety, tolerability and immunogenicity of the original Pfizer-BioNTech COVID-19 vaccine in 3 age groups: five to less than 12 years of age; elderly from 2 to less than five years; and elderly from 6 months to less than 2 years. Based on the dose escalation portion of the Phase 1 trial, youth aged five to less than 12 years gained a two-dose 10 μg program while youth under five years gained 3 reduced doses of 3 μg in the phase 2/3 study. The trial enrolled young people with or without prior evidence of SARS-CoV-2 infection.
AUTHORIZED USE IN THE EU: COMIRNATY® ▼ (Pfizer-BioNTech’s COVID-19 vaccine) has obtained People’s Marketing Authorization (MA) from the European Commission to prevent coronavirus disease 2019 (COVID-19) in other people over the age of five years. The vaccine is given in a series of 2 doses, 3 weeks apart. Adults and adolescents 12 years and older get 30 micrograms according to dose; Children older than five to 11 years get 10 micrograms according to the dose. In addition, the marketing authorization was extended to include a booster dose (3rd dose) at least 3 months after the current dose in other people older than 12 years. A third dose of cycle number one may be given at least 28 days after the current dose to other people aged five years or older with severely weakened immune systems. 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 is already sufficiently physically powerful knowledge on the quality, protection and efficacy of the vaccine. available. also received popular marketing authorization for two suitable vaccines: COMIRNATY Original/Omicron BA. 1, which comprises the mRNA encoding the wild-type spike protein and the Omicron BA. 1 subvariant of SARS-CoV-2; and COMIRNATY Original/Omicron BA. 4-five, comprising the mRNA encoding the wild-type spike protein and the Omicron BA. 4/BA. five subvariant of SARS-CoV-2. COMIRNATY Original/Omicron BA. 1 or COMIRNATY Original/Omicron BA. 4-five can be given as a booster to other people 12 years of age and older who have had at least one COVID-19 #1 vaccine. There will have to be a constant gap of at least 3 months between the use of COMIRNATY Original/Omicron BA. 1 or COMIRNATY Original/Omicron BA. 4-five and the last missed dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION:
The black equilateral triangle ▼ indicates that further follow-up is needed to stumble upon any adverse effects. This will allow new security data to be temporarily identified. People can help by reporting any side effects they may be experiencing. Side effects can be reported to medinfo @biontech. de, www. biontech. com or directly to BioNTech email, phone 49 6131 9084 0 or website.
About Pfizer: Breakthroughs That Replace Patients’ Lives We try to establish the popularity in quality, protection and price in the discovery, progression and manufacture of health care products, adding cutting-edge medicines 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 more than 170 years, we have worked to make a difference for everyone who relies on us. We publish information that could be vital for investors on our online page in www. pfizer. com. Also, to be more informed, stop by us and follow us on Twitter on @Pfizer and @Pfizer News, LinkedIn, YouTube and like on Facebook k on Facebook. com/Pfizer.
Pfizer Disclosure Notice The data in this release is dated October 19, 2022. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this press release, whether as a result of new data, 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) (added pending EMA submission and CHMP opinion for COMIRNATY (COVID-19 vaccine) 3 μg dose 19, mRNA), which is discovered in nature -type spike protein of SARS-CoV-2, as a three-dose series for children older than 6 months to less than five years (also called 6 months to four years, a regulatory pathway for prospective approval of Omicron BA. four of the companies). BA. five bivalent COVID-19 vaccine suitable for use in children under five years of age and a phase 1/2/3 pediatric review of the bivalent COVID-19 vaccine adapted Omicron BA. four/BA. five, qualitative tests of knowledge possible benefits , clinical trial expectations, prospective regulatory filings, the expected timing of knowledge readings, regulatory filings, regulatory approvals or clearances, and expected production, distribution, and source) involving genuinely extensive threats and uncertainties that may also simply differ genuine cause and effect. 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 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 schedules that would potentially be pending or submitted for BNT162b2 (adding any schedules for emergency use adjustments or conditional marketing authorizations and pending submission to the EMA for a 3 mcg dose of COMIRNATY (COVID-19 vaccine, mRNA ), which is found in the wild-type spike protein of SARS-CoV-2, as a three-dose series for children older than 6 months to less than five years), any applicant for monovalent or bivalent vaccine or other vaccines that may result of the BNT162 program would possibly be approved by a specific regulatory government, which will depend on a host of factors, including whether the benefits of the vaccine outweigh its known threats and determining the efficacy of the vaccine and, if approved, whether it will have advertising success. ; 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 newly discovered variants or next generation 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 threats and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ending December 31, 2021 and its forthcoming reports on Form 10-Q, adding the sections herein entitled “Risk Factors” and “Forward-Looking Information And Factors That May Affect Future Results,” and in its forthcoming reports on Form 8-K, all of which are filed with the United States Securities and Exchange Commission and are located at www. sec. gov and www. . pfizer. com.
About BioNTechBiopharmaceutical New Technologies is a next-generation immunotherapy company pioneering novel treatments for cancer and other serious diseases. The company leverages a wide variety of discovery informatics platforms and curative drugs for the immediate progression of new biopharmaceuticals. Its broad portfolio of oncology product applicants includes individualized, ready-to-use mRNA-based therapies, cutting-edge chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies, and small molecules. Based on its deep expertise in mRNA vaccine progression and in-house production capabilities, BioNTech and collaborators are introducing several mRNA vaccine applicants for a variety of infectious diseases across its diversified oncology portfolio. gun and Pfizer. For more information, visit www. BioNTech. com.
Forward-Looking Statements by BioNTech This press release includes “forward-looking statements” by BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements would possibly include, among others, statements regarding: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer adding the progression program of a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (adding the prospective in young people from 6 months to five years and a positive CHMP opinion on the management in children 6 months to 5 years of age in the EU, clinical trials investigating the use of BNT162b2 and its adapted vaccine variants in children 6 months to 12 years of age, an EUA in the United States, and an ongoing submission to EMA for a bivalent Omicron BA. four/BA. five COVID-19 vaccine suitable for children aged five to less than 12 years, qualitative evidence of knowledge, potential benefits, clinical trial expectations Array expected schedule of regulatory submissions, regulatory approvals o authorizations and expected production, distribution and origin); our expectations related to the prospective characteristics of BNT162b2 in our clinical trials, real-world insight studies, and/or advertising use based on insight observations to date; preclinical and clinical knowledge (adding Phase 1/2/3 or Phase four knowledge), adding descriptive knowledge discussed in this release, for BNT162b2 or any other candidate vaccine in the BNT162 program in any of our pediatric, adolescent, or adult studies or actual -worldwide evidence, adding the option of new adverse preclinical, clinical, or protective knowledge, adding the threat that the final or actual effects of the clinical trial may differ from knowledge number one; the ability of BNT162b2 or a long-term vaccine to save you from COVID-19 caused by emerging viral variants; the expected timing for further reading on the efficacy insights of BNT162b2 and its vaccine-adapted diversifications in our clinical trials; the nature of clinical knowledge, which is subject to ongoing peer review, regulatory review, and market interpretation; widespread use of BNT162b2 and its adapted vaccine variants will lead to new data on efficacy, protection, or other progressions, adding the threat of additional adverse effects, some of which could be serious; the time of submission of data for BNT162, or any long-term vaccine, in additional populations (including children 6 months to less than five years of age, possible long-term annual boosters or revaccinations), or receipt of any authorization placing on the market or emergency use authorization or equivalent, adding or modifying or diversifying such authorizations, adding determine whether the benefits of the vaccine outweigh its known threats and determine the efficacy of the vaccine and, if approved, whether it will be a advertising success; progression from other vaccine formulations, booster doses or possible long-term annual boosters or revaccinations or new variant-based vaccines; our proposed shipping and garage plan, adding the estimated shelf life of our products at other temperatures; BioNTech’s ability to source the right amounts of BNT162 and its vaccine variants to support clinical progression and market demand, adding our 2022 production estimates; require situations similar to those that the public accepts as true or knowledge of vaccines; regulatory government decisions have an effect on labeling or placement on the market, production processes, protection, and/or other issues that could affect the availability or potential publicity of a vaccine, adding progression of products or treatments through 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; the availability of raw tissues to make BNT162 or some other vaccine formulation; demanding situations similar to our vaccine formulation, dosing schedule and garage, distribution and management requirements, adding post-delivery garage and threat management; 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. of 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 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 hazards and uncertainties, please refer to BioNTech’s Quarterly Report on Form 6-K for the quarter ended June 30, 2022, filed with the SEC on August 8, 2022, located on the SEC’s online page at www. sec. gov. All data in this press release is as of the date of publication, and BioNTech assumes no legal responsibility to update such data as required by law.
CONTACTS
Pfizer: Media Relations 1 (212) 733-1226 PfizerMediaRelations@pfizer. com
Investor Relations 1 (212) 733-4848 IR@pfizer. com
BioNTech: Media Relations Jasmina Alatovic (0)6131 9084 1513 Media@biontech. de
Investor Relations Sylke Maas, Ph. D. 49 (0)6131 9084 1074 Investors@biontech. de