AUTHORIZED USE IN THE EU: COMIRNATY® ▼ has received a marketing authorization (MAA) from the European Commission to protect coronavirus disease 2019 (COVID-19) in people aged 6 months or older. The vaccine is administered in a single dose to seniors five years of age or older, and in a three-dose series to infants and children older than six months to four years who have not had COVID-19, receiving the first two doses in three doses. weeks apart, followed by a third dose administered at least 8 weeks after the second dose. Adults and adolescents over 12 years of age receive 30 micrograms per dose; children five to 11 years old receive 10 micrograms per dose; Infants and children older than 6 months to 4 years receive 3 micrograms per dose. Additional doses would possibly be given to Americans ages 5 and older who are severely immunocompromised, in line with national recommendations. 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 must be sufficiently physically powerful knowledge about the quality, protection and efficacy of the vaccineArray
In addition, COMIRNATY has also received a popular marketing authorization for two adapted vaccines: COMIRNATY Original/Omicron BA. 4-5, whose mRNA encodes the wild-type spike protein and the Omicron BA. 4/BA. 5. SARS-CoV-2 subvariant; and COMIRNATY Omicron XBB. 1. 5, which is the mRNA that encodes the spike protein of the Omicron XBB. 1. 5 subvariant of SARS-CoV-2.
COMIRNATY Omicron XBB. 1. 5 could be administered as a single dose regardless of previous vaccination status in Americans five years of age and older. Children ages 6 months to four years can get one or three doses depending on whether they’ve had a number one vaccination or had COVID-19. A period of at least 3 months will have to elapse between the administration of COMIRNATY Original/Omicron BA. four-five or COMIRNATY Omicron XBB. 1. five and the last previous dose of a COVID vaccine. -19 vaccine.
IMPORTANT SAFETY 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 in this press release is as of June 27, 2024. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this press release, whether 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 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), comprising a monovalent COVID-19 vaccine candidate adapted by Omicron based on the JN. 1 lineage, adding a submission to the European Medicines Agency (EMA) for a vaccine monovalent COVID-19 vaccine suitable for Omicron -19, based on JN. 1 lineage, expectations related to the COVID-19 vaccine application, planned regulatory submissions, qualitative evidence of available knowledge, potential benefits, clinical trial expectations, prospective regulatory filings, expected reading of knowledge The schedule, regulatory filings, regulatory approvals or authorizations and expected production, distribution and sourcing involve significant threats and uncertainties that may also cause actual effects to differ materially from those expressed or implied in said statements. Risks and uncertainties include, but are not limited to, uncertainties inherent to the studies and progression, as well as the ability to achieve expected clinical endpoints, start and/or completion dates of clinical trials, 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 insights and additional analyzes of existing preclinical insights, 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 journals and, if so, when and with what changes and interpretations; whether the regulatory government will be satisfied with the design and effects of those clinical and preclinical 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 bivalent, higher dose or vaccine-based vaccine and, if discharged, whether such emergency use authorizations or licenses will expire or terminate; whether 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 applicant (adding submission to the EMA of a monovalent COVID-19 vaccine suitable for candidate vaccine from Omicron, founded on the JN. 1 lineage), or other vaccines possibly resulting from the BNT162 program would likely be approved through a specific regulatory government, which will depend on myriad factors, in addition to determining whether the benefits of the vaccine outweigh its known benefits. . the threats and determination of the vaccine’s 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, including 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 resulting 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 vaccines; 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 regarding 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 found 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” and its upcoming reports on Form 8-K, all of which are filed with the U. S. Securities and Exchange Commission. They can be obtained from www. sec. gov and www. pfizer. COM.
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: 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 adapted monovalent COVID-19 vaccine Omicron JN. 1; qualitative evidence of available knowledge and expectations of possible benefits, adding the reaction of the adapted vaccine against several Omicron JN. 1 sublineages, adding KP. 2, KP. 3 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 hazards and uncertainties include, but are not limited to: uncertainties inherent to the studies and progression, adding the ability to achieve expected clinical endpoints, clinical trial start and/or completion dates, regulatory submission dates, regulatory approval and/or or release. 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 fitness 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; the formulations of our vaccine, its dosing schedule and the relevant storage, distribution and handling requirements, adding the relevant hazards with 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 public health governments 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 systems, 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 successfully scale BioNTech’s manufacturing functions and manufacture BioNTech’s products, adding targeted production grades of BioNTech’s COVID-19 vaccine 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 March 31, 2024, as well as in BioNTech’s upcoming filings with the SEC, which are located on the SEC’s website. website. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any purpose or responsibility to update or revise any forward-looking statements contained in this press release as a result of new, long-term information. advances or otherwise.
CONTACT
Investor Relations 1 (212) 733-4848IR@pfizer. com
BioNTech: Media RelationsJasmina Alatovic (0)6131 9084 1513Media@biontech. de
Investor RelationsVictoria Meissner, M. D. 8293Investors@biontech. de 1,617,528
———- 1 World Health Organization (WHO) on the antigenic composition of COVID-19 vaccines. April 26, 2024. Available at: https://www. who. int/news/item/26 -04-2024–on-the-antigen-composition-of-covid-19-vaccines#:~:text= In May 2023, GAD,1. 5, as well as the antigen vaccine (Accessed on 26. 06. 2024).
3 The European Medicines Agency (EMA) ETF recommends upgrading COVID-19 vaccines to the new JN. 1 variant. April 30, 2024. Available at: https://www. ema. europa. eu/en/news/etf-recommends -covid-19-vaccine-update–new-variant-jn1 (accessed on 26. 06. 2024).
4 Advisory Committee on Vaccines and Biologics Related to Biologics June 5, 2024 Meeting Presentation: Pfizer/BioNTech Supporting Clinical and Preclinical Data Vaccine Formula 2024-2025 COVID19. https://www. fda. gov/media/179144/download (accessed 06. 26. 06. 2024).