About Respiratory Diseases SARS-CoV-2 has caused a global pandemic with more than 6. 5 million deathssi and a heavy socioeconomic burden worldwide. ii While vaccines can combat the disease, COVID-19 is expected to remain a severe and circulating respiratory disease. . , which requires changes in vaccines for variants of concern. This is reminiscent of influenza, another respiratory illness that requires repeated vaccinations due to its genomic instability that leads to changes in the surface protein, hemagglutinin. Each year, influenza causes up to one billion infections, five million hospitalizations, and 650,000 deaths worldwide. iii
INDICATION, PERMITTED USE AND IMPORTANT SAFETY INFORMATION
INDICATIONCOMIRNATY® (COVID-19 vaccine, mRNA) is a vaccine intended for people 12 years of age and older who are opposed to coronavirus disease 2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
*COMIRNATY (Form 2023-2024) is manufactured in the same way as the Pfizer-BioNTech COVID-19 vaccine (original monovalent) and the Pfizer-BioNTech COVID-19 vaccine, which are bivalent, but encode the Omicron spike protein. SARS-CoV-2. XBB. 1. 5 (Omicron XBB. 1. 5) lineage variant.
These may not be all the conceivable side effects of COMIRNATY. Ask your doctor about side effects that affect you.
You can report vaccine effects to the FDA/CDC Vaccine Adverse Event Reporting System.
You can also report the effects to Pfizer Inc. at www. pfizersafetyreporting. com or by calling 1-800-438-1985.
Click here for the full COMIRNATY recipe.
PERMITTED USE
The Pfizer-BioNTech COVID-19 vaccine (2023-2024 form)* 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. *Hereinafter referred to as the Pfizer-BioNTech COVID-19 vaccine
EMERGENCY USE AUTHORIZATION
The Pfizer-BioNTech COVID-19 vaccine has not been approved or legal by the FDA, but has been legal for emergency use by the FDA, as part of an EUA to save coronavirus disease 2019 (COVID-19), for use in Americans. Emergency use of this product is permitted only for the duration of the declaration that there are cases justifying emergency use authorization of the medical product under Section 564(b)(1) of the FD Act.
IMPORTANT SAFETY INFORMATION
These may not be all side effects imaginable. Serious and unexpected side effects are possible. Call your vaccine provider or health care provider about any bothersome side effects or side effects that don’t go away.
Report vaccine side effects to the U. S. Food and Drug Administration. U. S. Include “Pfizer-BioNTech COVID-19 Vaccine (2023-2024) EUA Formula” in the first row of box 18 of the reporting form.
In addition, Americans can report the effects to Pfizer Inc. www. pfizersafetyreporting. com or by calling 1-800-438-1985.
Click to view the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Health Care Providers and the EUA Vaccine Recipients and Caregivers Fact Sheet.
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 more than 170 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 Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook. com/Pfizer.
Pfizer Disclosure Notice The data in this press release is as of October 26, 2023. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this release, whether as a result of new data or long-term events or developments.
This release includes prospective data on the Pfizer and BioNTech combination mRNA vaccine candidate for influenza and COVID-19 in healthy adults ages 18 to 6 years, adding its potential benefits, plans to launch a pivotal trial phase 3, Pfizer’s ambition to obtain a broad portfolio of respiratory mixture vaccines, Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to expand a COVID-19 vaccine, the mRNA vaccine program BNT162 and Pfizer and BioNTech’s COVID-19 vaccines, jointly explained here as COMIRNATY (add qualitative evidence of available knowledge, potential benefits, clinical trial expectations, set of prospective regulatory submissions, expected timeline of knowledge readout, regulatory submissions, approvals or regulatory authorizations and expected production, distribution and sourcing) involve significant threats and uncertainties that may also simply cause actual facts to differ materially from those expressed or implied by such statements. Risks and uncertainties include, but are not limited to, uncertainties inherent to the studies and expansion, as well as the ability to achieve expected clinical endpoints, clinical trial start and/or completion dates, regulatory submission dates, of regulatory approval and/or launch dates, as well as the uncertainties inherent to studies and expansion. applicable. as well as relevant threats with preclinical and clinical knowledge (adding Phase 1/2/3 or Phase Four or preclinical knowledge for the Pfizer and BioNTech mixture mRNA vaccine candidate for influenza and COVID-19Array COMIRNATY or any other Pfizer vaccine. respiratory vaccine applicants, adding the knowledge discussed in this release) in any of our studies in pediatrics, adolescents or adults or real-world evidence, adding the option of new unfavorable preclinical, clinical or protective knowledge and additional analyzes of preclinical data, existing clinical or protective knowledge. clinical, clinical or safety data or additional information related to the quality of preclinical, clinical or safety data, adding the risk that additional data related to the new Omicron sublines may differ from previously reported data; the ability to produce comparable clinical or other effects for the Pfizer and BioNTech mRNA mixture influenza and COVID-19 vaccine candidate, COMIRNATY or any other Pfizer respiratory vaccine candidate, adding the effectiveness rate of the vaccine and the protection and tolerance profile observed updated and additional studies, in real-world knowledge studies or in larger and more varied post-marketing populations; the ability of Pfizer and BioNTech’s mRNA-based combination influenza and COVID-19 vaccine candidate, COMIRNATY, or any of Pfizer’s other respiratory vaccine applicants, to save you from COVID-19 caused by emerging viral variants; the threat that use of the vaccine will lead to new data on efficacy, protection or other improvements, adding the threat of additional adverse reactions, some of which would possibly be serious; the threat that knowledge from clinical and preclinical trials is possibly subject to further interpretation and evaluation, including during the peer review/publication process, sometimes in the clinical network and through regulatory governance; whether and when additional insights from the BNT162 mRNA vaccine program or other COVID-19 systems 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 existing or long-term clinical and preclinical studies; if and when submissions are made to request emergency use or conditional marketing authorizations for the mRNA-based combination influenza and COVID-19 vaccine candidate from Pfizer and BioNTech, COMIRNATY or one of the other Pfizer respiratory vaccine applicants in additional populations, for a possible booster dose for COMIRNATY, any vaccine applicants or any potential long-term vaccines (adding possible long-term annual boosters or revaccinations) and/or other licensing programs. Biologics and/or emergency use authorization programs or modifications to those programs would likely be introduced in specific jurisdictions for Pfizer and BioNTech mRNA. . – the combined influenza and COVID-19 vaccine candidate, COMIRNATY or any other Pfizer respiratory vaccine candidate, and if discharged, whether such emergency use authorizations or licenses, or existing emergency use authorizations, will expire or they will end; if and when programs were potentially being finalized or submitted for the mRNA-based combination influenza and COVID-19 vaccine candidate from Pfizer and BioNTech, COMIRNATY or any of Pfizer’s other respiratory vaccine applicants (adding any requested amendments to the use of emergency or conditional marketing authorizations) possibly be approved through a specific regulatory government, which will depend on a multitude of factors, including determining whether the vaccine’s benefits outweigh its known threats and determining the vaccine’s effectiveness and , if approved, if it will have a publicity success; Decisions through regulatory governance have an effect on labeling or marketing, production processes, protection and/or other issues that would possibly have effects on the availability or potential advertising of a vaccine, including the authorization or approval of products or treatments developed through other corporations; intellectual assets and other disputes; interruptions in appointments between us and our collaboration partners, clinical trial sites or third-party providers, adding our appointments with BioNTech; the threat that demand for a product will be reduced, no longer exist or do not meet expectations, which would possibly result in a reduction in profits, excess stock on hand and/or in the channel which, for COMIRNATY, has resulted in stock write-offs and other fees and may also continue to result in stock cancellations or other unexpected adjustments; similar demanding situations and uncertainties related to the timing of the transition to the advertising market for any of our products; uncertainties similar to public compliance with vaccines and boosters; threats such as our ability to achieve our earnings forecasts for Pfizer and BioNTech’s combination mRNA-based influenza and COVID-19 vaccine candidate, COMIRNATY or any of Pfizer’s respiratory vaccine applicants; 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 variant-based or next-generation vaccines or mixed vaccine prospects; the threat that we may not be able to maintain our production capacity or access to logistics or supply channels to meet global demand for our vaccines, which would negatively impact our ability to obtain our vaccines on time; whether and when additional purchasing or sourcing agreements will be entered into or existing agreements will be supplemented or renegotiated; 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; challenging pricing and access situations; demanding situations similar to what the public accepts as true or aware of the mRNA-based combination influenza and COVID-19 vaccine candidate from Pfizer and BioNTech, COMIRNATY or any of the applicants for the Pfizer respiratory vaccine; uncertainties related to future changes to current public health policies and guidance issued by the U. S. federal government in connection with the government’s declared end to the COVID-19 public health emergency effective May 11, 2023; industry restrictions; any third party royalties or other claims; uncertainties inherent in business and monetary planning, including, among others, threats related to Pfizer’s business and prospects, adverse expansions in Pfizer’s markets, or adverse expansions in the United States or global monetary markets, credit markets , the regulatory environment or economies sometimes; uncertainties related to the effect of COVID-19 on Pfizer’s business, operations and financial effects; and competitive expansions.
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, 2022 and its upcoming reports on Form 10-Q, by adding in the sections entitled “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results” and its upcoming reports on Form 8-K, all of which are filed with the U. S. Securities and Exchange Commission. They are available at www. sec. gov and www. pfizer. com. . com.
About BioNTech Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering new treatments for cancer and other serious diseases. The company operates a wide variety of drug discovery and cure informatics platforms for the immediate progression of new biopharmaceuticals. Its broad portfolio of oncology product applicants include individualized and commercially available mRNA-based treatments, cutting-edge chimeric antigen receptor (CAR) T cells, protein-based therapeutics that add bispecific immune checkpoint modulators, targeted cancer antibodies, and antibody-drug conjugates (ADCs). as well as small molecules. Drawing on its deep expertise in mRNA vaccine progression and in-house production capabilities, BioNTech and its collaborators are submitting applicants for mRNA vaccines for a variety of infectious diseases, across its diverse oncology portfolio. BioNTech has established a wide variety of relationships with a number of global companies. pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Roche Group member Genentech, Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer.
For more information, visit www. BioNTech. com.
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: the release, timing, progress and the effects of BioNTech. Studies and effects. formulas for progression in the field of infectious diseases, in particular the collaboration between BioNTech and Pfizer; existing and long-term clinical trials of applicants for combination mRNA vaccines from BioNTech and Pfizer for influenza and COVID-19, adding statements related to the timing of the start and end of the studies or trials, adding the planned start of the Phase 3 pivotal testing, relevant preparatory paints and availability. of effects; time for any knowledge reading; the potential protection and effectiveness of applicants for BioNTech products; BioNTech’s expected market position opportunity and the duration of its product applicants; Qualitative evidence of available knowledge and expectations of potential benefits, adding initial effects from a Phase 1/2 trial comparing protection, tolerance and immunogenicity of BioNTech and Pfizer mRNA combination influenza vaccine applicants and COVID-19 in adults in good physical condition 18 to 64 years of age; 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 certain cases, forward-looking statements may be referred to by terminology such as “will,” “may,” “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 may cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These dangers and insecurities include, but are not limited to: uncertainties inherent to studies and progression. Array that adds the ability to achieve expected clinical endpoints, clinical trial start and/or end 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 ongoing peer review, regulatory review and market position interpretation; long-term business calls and medical needs; the availability of raw materials to manufacture a vaccine; the formulation, dosing schedule and relevant storage, distribution and management requirements of BioNTech vaccines, adding similar risks to storage and handling after delivery; festival of other products and product applicants, adding those with other mechanisms of action and other production and distribution limitations, based on, among other things, effectiveness, cost, convenience and garage distribution, degree of approved use, profile of effects appearance and toughness of immune response; the ability to download recommendations from vaccine technical or advisory committees and other public health governments and uncertainties related to advertising affect such recommendations; the timing and ability of BioNTech to discharge and maintain regulatory approval for BioNTech’s product applicants; the ability of BioNTech’s COVID-19 vaccines, adding Pfizer and BioNTech’s combined mRNA vaccine applicants for influenza and COVID-19, to protect against COVID-19 and/or influenza 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 formulas, supply chain, artists and financial performance; Unexpected protection issues and possible claims that would arise from the use of the BioNTech COVID-19 vaccine and other products and applicants for products evolved or manufactured through BioNTech, adding the applicants for combination vaccines founded by Pfizer and BioNTech mRNA who oppose to influenza and COVID-19. ; The ability of BioNTech and its collaborators to market and advertise BioNTech’s COVID-19 vaccine and, if approved, its product applicants, adding Pfizer and BioNTech’s combined mRNA-based influenza vaccine applicants and COVID -19; 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 position; and other points unknown to BioNTech at this time.
You deserve the dangers and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2023, and BioNTech’s upcoming filings with the U. S. Securities and Exchange Commission. U. S. Securities and Exchange Commission (“SEC”), which can be found on the SEC’s website in www. sec. gov. Except as required by law, BioNTech disclaims any objective or duty to update or revise any forward-looking statements contained in this press release, whether as a result of new information, long-term developments or otherwise. These forward-looking statements are based on BioNTech’s existing expectations and speak only as of the date hereof.
CONTACTS
Pfizer: Media Relations 1 (212) 733-1226 PfizerMediaRelations@pfizer. com
Investor Relations 1 (212) 733-4848IR@pfizer. com
BioNTech: Media Relations Jasmina Alatovic (0)6131 9084 1513Media@biontech. de
Investor RelationsVictoria Meissner, M. D. 1 617 528 8293Investors@biontech. de —–
i World Health Organization Coronavirus
ii Delardas O, Kechagias KS, Pontikos PN, Giannos P. Socioeconomic Effects and Demanding Situations of the Coronavirus Pandemic
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