NEW YORK and MAÏNZ, GERMANY, August 22, 2024 – Pfizer Inc. (Nasdaq: BNTX, “BioNTech”) announced that the United States Food and Drug Administration (“FDA”) has approved the supplemental license application for biologics for others. over 12 años. de age and older (COMIRNATY® (COVID-19 vaccine, mRNA)) and obtained emergency use authorization for other people aged 6 months to 11 years (Pfizer-BioNTech COVID-19 vaccine) from Omicron KP. 2 adapted to 2024 from companies. -COVID-19 Vaccine Formula 202five. This season’s vaccine is designed to be used as a single dose for up to people five years of age and older. People five years of age and older with certain types of immunosuppression who have already been vaccinated with the Pfizer and BioNTech COVID-19 vaccines or children under the age of five who have not yet completed a three-dose series with previous formulations of a COVID-19 vaccine may be eligible to receive more doses.
The adaptation of KP. 2 is based on FDA guidance, which states that KP. 2 is the preferred strain of the JN. 1 lineage for COVID-19 vaccines that will be used in the United States during the fall season. and the winter of 2024-2025, if possible. 1 Staying up to date with vaccinations in accordance with the Centers for Disease Control and Prevention (“CDC”) recommendations remains important, especially in light of the new surge of COVID-19 cases. 2 This season, the Pfizer and BioNTech COVID-19 vaccine will begin shipping without delay and will be available in pharmacies, hospitals and clinics across the United States in the coming days.
The approval is based on the totality of past clinical, non-clinical and real-world evidence supporting the protection and effectiveness of the Pfizer and BioNTech COVID-19 vaccines. The application also included production and non-clinical knowledge that appears to be the KP. 2-adapted vaccine generates a particularly accelerated reaction against the Omicron JN. 1 sublineages circulating lately, adding KP. 2, KP. 3 and LB. 1, to companies. Omicron XBB. 1. 5 COVID-19. 3 Vaccine
Pfizer and BioNTech’s COVID-19 vaccines are based on BioNTech’s proprietary mRNA generation and were developed through both companies. BioNTech holds marketing authorization for COMIRNATY® and its adapted vaccines (COMIRNATY® (COVID-19 vaccine, mRNA); COMIRNATY® Original/Omicron BA . 1; COMIRNATY® Original/Omicron BA. 4-5; COMIRNATY® Omicron XBB. 1. 5; COMIRNATY® JN. 1) in the United States, the European Union, the United Kingdom and other countries, and holders of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
INDICATION, PERMITTED USE AND IMPORTANT SAFETY INFORMATION
INDICATIONCOMIRNATY® (COVID-19 vaccine, mRNA) is a vaccine intended for use in Americans 12 years of age and older who oppose coronavirus disease 2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
Before receiving COMIRNATY, tell your vaccine provider about any concerns about your physical status and add if:
Additional reactions that have been reported with the COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:
These may not be all the imaginable side effects of COMIRNATY. Ask your doctor about any side effects that affect you.
You can report adverse events to the FDA/CDC Vaccine Adverse Event Reporting System. In addition, you can report effects to Pfizer Inc. al 1-800-438-1985 or www. pfizersafetyreporting. com
Click here for complete prescription data and patient data from COMIRNATY. If it is not available through those links, it will be visual as soon as we can finalize the documents. Check back soon for complete data.
PERMITTED USE
The Pfizer-BioNTech COVID-19 vaccine (2024-2025 formula)* is legal through the FDA under an Emergency Use Authorization (EUA) to save you from coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Americans 6 months through 11 years of age. *Onwards, Pfizer-BioNTech COVID-19 vaccine.
EMERGENCY USE AUTHORIZATION
Emergency uses of the BioNTech and Pfizer COVID-19 vaccines, the Pfizer-BioNTech COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
Additional symptoms, especially in children, may include:
These may not be all the side effects imaginable. Serious and unexpected side effects may occur. Call your vaccine provider or health care provider about bothersome side effects or side effects that don’t go away.
Report vaccine side effects to the United States Food and Drug Administration. Please include “Pfizer-BioNTech COVID-19 Vaccine (Form 2024-2025) EUA” in the first row of box 18 of the report form.
Additionally, Americans can report effects to Pfizer Inc. at www. pfizersafetyreporting. com or by calling 1-800-438-1985.
Click here to view the Pfizer-BioNTech COVID-19 Vaccine Healthcare Provider Fact Sheet and the EUA Vaccine Recipients and Caregivers Fact Sheet. If it is not currently available through those links, it will be visualized as soon as possible while we work. to finalize the documents. Check back soon for complete information.
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 contained in this release is as of August 22, 2024. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this release as a result of new data or developments or long-term 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), adding approval in the United States for a COVID-19 vaccine adapted to the KP. 2 strain of the SARS-CoV-2 lineage Omicron JN. 1Array pending submissions to other governments regulators, expectations related to demand for COVID-19 vaccines, expected regulatory submissions, qualitative evidence of available knowledge, potential benefits, clinical trial expectations, potential regulatory submissions, the expected timing of data readouts, regulatory submissions, approvals or authorizations regulatory and expected availability, 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, among other things, inherent uncertainties of the studies and progression, as well as the ability to achieve expected clinical endpoints, clinical trial start and/or completion dates, regulatory submission dates, regulatory approval dates and/or launch dates. as appropriate. 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 other interpretations and evaluations, 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 potential 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; if and when 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 submissions to the regulatory government for KP-adapted COVID-19 vaccine . 2 of (the SARS-CoV-2 Omicron JN. 1 line), or other vaccines possibly resulting from the BNT162 program, would possibly be approved through an express regulatory government, which will depend on a myriad of factors, in addition to determining whether the benefits of the vaccine outweigh the known threats and determine its 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, adding to 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 such as public aid for vaccines, boosters, treatments 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 threats such as 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 vaccines based on vaccine variants or combinations; 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 related to 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 discovered 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,” as well as in its upcoming reports on Form 8-K, all of which are filed with the United States Securities and Exchange Commission and can be obtained at www. sec. gov and www. pfizerArraycom.
About BioNTechNew Biopharmaceutical Technologies.
BioNTech Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, among others, statements relating to: BioNTech’s efforts to combat COVID -19; the collaboration between BioNTech and Pfizer; the rate and degree of acceptance of the market position of BioNTech’s COVID-19 vaccine, adding the monovalent COVID-19 vaccine adapted to Omicron JN. 1 (adding the SARS-CoV strain KP. 2-2 sublineage Omicron JN. 1); qualitative evidence of available knowledge and expectations of possible benefits, adding the reaction of the adapted vaccine against the Omicron JN. 1 sublineages, adding KP. 2 and other sublineages recently in circulation; regulatory filings and regulatory approvals or authorizations and expectations related to production, distribution and sourcing; expectations related to expected adjustments to the ordering of COVID-19 vaccines, adding adjustments to the ordering environment; and expected regulatory recommendations to adapt vaccines to respond to new variants or sublineages. In some cases, forward-looking statements may be referred to by terminology such as “may”, “could”, “deserve”, “expect”, “intend”, “plan”, “target”, “anticipate”, “believe”. ”, “estimates”, “predicts”, “prospective”, “continue” or the negative of those terms or other comparable terminology, although not all forward-looking statements involve those words. The forward-looking statements included in this press release are neither promises nor guarantees, and you should not place undue reliance on such forward-looking statements because they involve known and unknown dangers, uncertainties and other matters, many of which are beyond the control of BioNTech and which may cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These dangers and uncertainties include, but are not limited to: uncertainties inherent to studies and progression. Matrix that aggregates the ability to achieve expected clinical endpoints, clinical trial start and/or completion dates, regulatory submission dates, regulatory approval, and/or launch dates. dates, as well as the relevant risks with the preclinical and clinical knowledge, adding the knowledge discussed in this communication, and adding the option of new adverse preclinical, clinical or protective data and additional analyzes of the preclinical, clinical or protective knowledge. existing security; the nature of clinical knowledge, which is subject to peer review, regulatory review and interpretation of the ongoing market position; BioNTech’s pricing and policy negotiations with government, personal health insurers and other third-party payers following BioNTech’s initial sales to national governments; long-term advertising 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 formulations, their dosing schedule and relevant storage, distribution and handling requirements, adding similar hazards to storage and handling after delivery; festival of other COVID-19 vaccines or similar to other applicants for BioNTech products, adding those with other mechanisms of action and other production and distribution limitations, based, among other things, on effectiveness, cost of the set, convenience of storage and distribution, the scope of approved use. , appearance and duration effects profile of the immune reaction; the ability to download recommendations from vaccine technical or advisory committees and other government public health and uncertainties related to advertising affect such recommendations; the timing and ability of BioNTech to discharge and maintain regulatory approval for applicants for BioNTech products; the ability of BioNTech’s COVID-19 vaccines to rescue COVID-19 caused by emerging virus variants; The ability of BioNTech and its counterparties to manage and acquire mandatory energy resources; BioNTech’s ability to identify study opportunities and detect and expand investigational drugs; the ability and willingness of BioNTech’s external collaborators to pursue progression studies and activities similar to BioNTech’s progression and investigational drug applicants; the effect of the COVID-19 pandemic on BioNTech’s progression programs, supply chain, personnel and financial performance; unexpected protection issues and potential claims arising from the use of BioNTech’s COVID-19 vaccine and other products and product applicants developed or manufactured through BioNTech; the ability of BioNTech and its collaborators to advertise and publicize BioNTech’s COVID-19 vaccine and, if approved, its product applicants; BioNTech’s ability to manage its progression and expansion; regulatory progressions in the United States and other countries; BioNTech’s ability to scale BioNTech’s production functions well and manufacture BioNTech’s products, adding target production grades of BioNTech’s COVID-19 vaccines and BioNTech’s product applicants; similar dangers to the global monetary formula and market positions; and other points unknown 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 June 30, 2024, as well as in BioNTech’s upcoming filings with the SEC, which They are found on the SEC website. website. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any objective or responsibility to update or revise any forward-looking statements contained in this press release as a result of new information, in the long term. advances or otherwise.
CONTACTSPfizerMedia Relations 1 (212) 733-1226PfizerMediaRelations@pfizer. com
Investor Relations 1 (212) 733-4848IR@pfizer. com
BioNTechMedia Relations Jasmina Alatovic 49 (0)6131 9084 1513Media@biontech. de
Investor Relations Victoria Meissner, M. D. Investors@biontech. de
———
1 U. S. Food and Drug Administration Advisory Committee on Vaccines and Related Biological ProductsUSA3, June 5, 2024 Meeting Presentation: Pfizer/BioNTech Supporting Clinical and Preclinical Data 2024-2025 Vaccine Formula COVID19. https://www. fda. gov/media/179144/ download (accessed 28. 06. 2024).