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
These may not be all the conceivable side effects of COMIRNATY. Ask your doctor about side effects that affect you.
You can report the effects of the vaccine to the FDA and CDC Adverse Event Reporting System (VAERS). The toll-free number for VAERS is 1-800-822-7967 or report it online at www. vaers. hhs. gov/reportevent. html.
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.
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
Report vaccine side effects to the U. S. Food and Drug Administration. The U. S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The toll-free number for VAERS is 1-800-822-7967 or get it online at www. vaers. hhs. gov/reportevent. html. 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 Healthcare Providers and the EUA Fact Sheet for Vaccine Recipients and Caregivers.
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.
This release contains prospective data on Pfizer and BioNTech’s combination mRNA-based vaccine candidate against Los Angeles flu and COVID-19 for healthy adults aged 18 to 6 years, including potential benefits and pipelines. Launch of a Phase 3 pivot verification, PFIZER’s ambition to obtain a large portfolio of combined respiratory vaccines, Pfizer’s efforts to combat COVID-19, the joint collaboration between Biontech and PFIZER to expand a COVIV -19 vaccine, the ARNM BNT162 mRNM vaccine program and the PFIZER and BIONTECH COVID-19 vaccines, jointly explained here as CMIRNATY (adding qualitative knowledge assessments, potential benefits, expectations in terms of clinical trials. Organize prospective regulos angelestory presentations, expected reading schedule of knowledge, presentations of regulos angelestory, approvals or authorizations of regulos angelestory and expected production, distribution and source) involve significant threats and uncertainties that may also cause genuine effects that differ particularly from those expressed or implied through those statements. Risks and uncertainties include, among other things, uncertainties inherent to the studies and expansion, as well as the ability to achieve higher clinical parameters, initiation and/or clinical trials, regulatory filing dates, regulatory filing dates. angelestory, approval of angelestory regulations dates and/or lunch dates in Los Angeles, as the case may be. as well as relevant threats with preclinical and clinical knowledge (adding Phase 1/2/3 or Phase Four or preclinical knowledge for Pfizer and BioNTech’s mixed 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 genuine world evidence, adding the option of New preclinical, clinical or protective predominant knowledge and deeper analyzes of the knowledge existing preclinical, clinical or protective measures. security knowledge. clinical, clinical or protective knowledge or additional data related to the quality of preclinical, clinical or protective knowledge, adding the threat that additional knowledge related to the new Omicron sublines may possibly differ from knowledge reported in the past; The ability to produce clinical or other comparable effects for the biotech mRNA and mRNA-based combination vaccine candidate against influenza and COVID-19, CMIRNATY or any other PFIZER respiratory vaccine candidate, adding the vaccine potency rate and the protection and tolerance profile. observed to date and subsequent studies, in genuine world knowledge studies or in more varied and more varied post-commercialization populos angelestions; the ability of Pfizer and BioNTech’s mRNA-based influenza and COVID-19 vaccine candidate, COMIRNATY, or any of Pfizer’s other respiratory vaccine applicants, to rescue COVID-19 caused by emerging viral variants; The threat that the use of the vaccine will lead to new data on potency, protection or other extensions, adding the threat of greater adverse effects, some of which would possibly be serious; The threat of preclinical and clinical trial knowledge being subject to further interpretation and evaluation, including during the peer review/publication procedure, in the broader clinical network and through government regulatory regulations; Whether and when further insights into the VANM BNT162 vaccine program or other COVI-19 systems will be published in clinical journals and, if so, when and with what amendments and interpretations; Whether the government will be satisfied with the design and effects of existing or long-term clinical and preclinical studies; in the event of emergency use applications 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 applicants for Pfizer’s respiratory vaccine in other angel populations, for a possible booster dose for COMIRNATY, any vaccine applicants or any possible long-term vaccines (adding possible long-term annual boosters or revaccinations) and/or other licensing programs. Emergency use or biologic authorization programs or modifications to those programs would likely be filed in jurisdictions particular to Pfizer and BioNTech. mRNA. – The combined influenza and COVID-19 vaccine candidate, COMIRNATY or any other Pfizer respiratory vaccine, and if discharged, if or when such emergency use authorizations or licenses, or emergency use authorizations, expire or terminate; 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 government regulations, 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, whether it will be a publicity success; Government decisions regulate angelestory that have an effect on labeling or marketing, production procedures, safety and/or other issues most likely to the availability or prospective advertising of a vaccine, including the authorization or approval of products or treatments developed. through other companies; intellectual assets and other disputes; disruptions in relationships between us and our dealmaking partners, clinical trial sites or third-party providers, including our relationship with BioNTech; the threat that demand for any product will be reduced, no longer exist or do not meet expectations, which would possibly result in reduced income, excess stock on hand and/or in the channel which, for COMIRNATY, has resulted in stock and other price radiation and may also continue to cause stock radiation or other unforeseen adjustments; Relos angelested demanding situations and uncertainties Relos angelesting at the time of transition to the advertising market for any of our products; uncertainties related to public support for vaccines and reminders; The risks are our ability to make our revenue predictions for Pfizer and BioNTech’s mRNA-based combination vaccine candidate against LA flu and COVID-19, COMIRNATY or any other Pfizer respiratory vaccine candidates; the risk that other companies may produce superior or competitive products; threats related to the availability of raw materials to manufacture or test a vaccine; les défis liés à los angeles formulos angelestion de notre vaccin, au calfinishrier de dosage et aux exigences de stockage, de Distribution et d’administration qui en découlent, et compris les risques liés au stockage et à los angeles manipulos angelestion après livraison par Pfizer ; The risk that we will not move beyond development with the success of other vaccine formulas, dose increases or future events, annual doses or revaccinations or new vaccines based on variants or new generation or respiratory vaccines. combines prospective; 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 adversely affect our ability to obtain our vaccines within the expected time frames; If and when new supply or procurement agreements will be concluded or existing agreements will be finalized or renegotiated; uncertainties related to the ability to download recommendations from vaccine advisory or technical committees and other public health governments and uncertainties related to advertising affect those recommendations; challenging pricing and access situations; Demanding situations related to public trust or wisdom of the biotechnological mRNA and mRNA-based combination vaccine candidate against influenza and Covid-19, Cumirnaty or any other Pfizer respiratory candidate; uncertainties related to long-term changes to current public health policies and guidance issued by the US federal government in connection with the federal government’s end of the COVID-19 public health emergency effective 11 May 2023; restrictions announcements; les éventuelles redevances de tiers ou autres réclos angelesmations; The uncertainties inherent in los Angeles, in addition to advertising and financial angelification, include, without limitation, the risks of Pfizer’s activities and prospects, of unfavorable developments in Pfizer’s markets or of unfavorable developments in the United States. world financial markets, credit markets, regulatory environments and general economies; uncertainties related to the effect of COVID-19 on Pfizer’s business, operations and financial effects; et les évolutions concurrentielles.
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.
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) 733-1226PfizerMediaRelations@pfizer. com
Investor Relations 1 (212) 733-4848IR@pfizer. com
Investor RelationsVictoria Meissner, M. D. 1 617 528 8293Investors@biontech. de —–
i World Health Organization Coronavirus (COVID-19) Dashboard. Available in https://covid19. who. int/
ii Delardas O, Kechagias KS, Pontikos PN, Giannos P. Socioeconomic Affects and Challenging Situations of the Coronavirus (COVID-19) Pandemic: An Updated Review. Sustainability. 2022; 14(15):9699. https://doi. org/10. 3390/su14159699
iii Influenza (seasonal). World Health Organization. Available in https://www. who. int/news-room/fact-sheets/detail/influenza-(seasonal)