Update on Pfizer’s second-generation flu vaccine phase 2 trial
Pfizer’s Phase 2 trial (NCT06436703) to compare second-generation flu applicants was introduced earlier this year and enrolled 450 participants ages 18 to 64, who were randomly assigned to receive flu vaccines. experimental mRNA-based flu or flu vaccines approved by the US Food and Drug Administration (“FDA”). As previously reported, Pfizer announced early positive effects from Phase 3 of its first-generation quadrivalent vaccine candidate (“qIRV”), which provided the first and only demonstration of the efficacy of an mRNA vaccine in a group of participants. of the study aged between 18 and 18 years. 64. age. The number one endpoints of this first-generation qIRV candidate were not met in older adults aged 65 years and older due to statistically non-inferior relative vaccine effectiveness (“rVE”) compared to an approved influenza vaccine. accumulated cases. Pfizer has developed second-generation candidates with the goal of obtaining better immunogenicity and potentially greater protection, adding new tIRV formulations that meet updated recommendations from the World Health Organization (“World Health Organization”). WHO”) and the FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”). tIRV formulations elicited physically potent responses to influenza A and influenza B, adding a continuing trend toward responses superior to influenza A compared to an influenza vaccine. Data from this phase 2 trial involving adults over 65 years of age will be received at a later date.
Pfizer will also continue to compare its flu vaccination program and discuss next steps with fitness authorities.
About the Flu Flu causes between 140,000 and 710,000 hospitalizations each year, 12,000 to 52,000 deaths1, and approximately $25 billion in economic losses2 in the United States. People 65 and older are at higher risk for serious flu-related complications, adding hospitalization and death. 3 Even when a vaccine matches circulating strains well, existing flu vaccines typically provide 40% to 60% coverage each year, with even lower coverage in years when the strains do not match. 4 The Effect of Influenza on Flu Breeds and Teams Ethnic minorities in the United States is even more important. Black Americans are about twice as likely as their white counterparts to be hospitalized for the flu, while Latinos and Native Americans are 1. 2 and 1. 3 times more likely, respectively. . 5
INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION
INDICATIONCOMIRNATY® (COVID-19 vaccine, mRNA) is a vaccine for people over 12 years of age against coronavirus disease 2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
*COMIRNATY (2023-2024 formula) is manufactured in the same way as the Pfizer-BioNTech COVID-19 vaccine (original monovalent) and the Pfizer-BioNTech COVID-19 vaccine, bivalent, but encodes the spike protein of the Omicron variant of SARS. -CoV-2. XBB. 1. 5 (Omicron XBB. 1. 5).
These may not be all the imaginable side effects of COMIRNATY. Ask your doctor about any side effects that concern you. You may report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). VAERS’ toll-free number is 1-800-822-7967 or report online at www. vaers. hhs. gov/reportevent. html. Additionally, you may report side effects to Pfizer Inc. at 1-800-438-1985 or www. pfizersafetyreporting. com
Click here for the full recipe and patient of COMIRNATY
PERMITTED USE
The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formulation)* is legal through the FDA under an Emergency Use Authorization (EUA) to save you from coronavirus disease 2019 (COVID-19) caused by acute respiratory syndrome severe coronavirus 2 (SARS-CoV-2) in Americans 6 months to 11 years of age. *Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine
The Pfizer-BioNTech COVID-19 vaccine has not been approved or legal by the FDA, but it 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. 6 months to 11 years of age. age. Emergency use of this product is legal only for the duration of the declaration that there are cases justifying authorization of emergency use of the medical product under segment 564(b)(1) of the FD Act.
IMPORTANT SAFETY INFORMATION
These may not be all the side effects imaginable. Unforeseen, serious side effects are possible. Call the vaccine provider or healthcare provider about bothersome side effects or side effects that do not go away.
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’s (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online at www. vaers. hhs. gov/reportevent. html. Please come with “Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA” in the first line of box 18 of the report form.
Click to view the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Health Care 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 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 16, 2024. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this release as a result of new data or long-term events or developments.
This release includes prospective data on applicants for Pfizer’s investigational modified RNA (modRNA) influenza vaccine, potential next-generation mRNA influenza vaccine formulations and next-generation mixed vaccines, mRNA-based mixture of Pfizer and BioNTech influenza mRNA. and COVID-19, influenza and COVID. /influenza, Pfizer’s respiratory vaccine portfolio and mRNA technology, adding their potential benefits, which involve significant threats and uncertainties that may also cause actual effects to differ materially from those expressed or implied by those statements. Risks and uncertainties include, among other things, inherent uncertainties in the studies and progression, as well as the ability to achieve the expected clinical endpoints, the start and/or completion dates of our clinical trials, the submission dates, regulatory approval dates and/or launch dates. as well as the option of new adverse clinical data and additional analyzes of existing clinical data, adding uncertainties about the effects of the ongoing Phase 2 trial on applicants for Pfizer’s second-generation flu vaccine in adults aged 65 years or further; uncertainties related to the long-term progression of applicants for the Pfizer influenza mRNA vaccine, potential next-generation influenza mRNA vaccine formulations and mixed vaccines from Pfizer and BioNTech, as well as the vaccine candidate from Pfizer and BioNTech mRNA combination against influenza and COVID-19, add if or when those applicants will move to long-term studies or progression phases; the risk that clinical trial data will be subject to divergent interpretations and testing by the regulatory government; whether the regulatory government will be satisfied with the design and effects of our clinical studies; whether and when biologics licensing programs would be introduced in any jurisdiction for applicants for Pfizer’s mRNA influenza vaccines, potential next-generation mRNA influenza vaccine formulations or mixed vaccines, or Pfizer’s combination mRNA vaccine candidate. Pfizer and BioNTech for influenza and COVID-19 for any potential indication. or for any other potential vaccine or product candidate; whether and when such programs can be approved through the regulatory government, which will depend on a multitude of factors, in addition to determining whether the benefits of the product outweigh its known threats and determining whether the product is effective and, if approved, whether the vaccine applicants, potential next-generation mRNA influenza vaccine mixtures or formulations, the Pfizer and BioNTech combined influenza and COVID-19 mRNA vaccine candidate, or any other potential vaccine or product candidate they will achieve advertising success; Decisions through regulatory governance have an effect on labeling, production processes, protection and/or other issues that may also affect the availability or advertising of Pfizer mRNA influenza vaccine applicants, Potential next-generation mRNA formulations or the combined flu vaccines, Pfizer and BioNTech mRNA. mixed influenza and COVID-19 vaccine candidate or any other potential vaccine or product candidate, adding product progression or treatments through other companies; uncertainties related to the ability to download recommendations from vaccine technical or advisory committees and other public fitness governments related to applicants for the Pfizer mRNA influenza vaccine, potential next-generation mRNA influenza vaccine formulations or mixed vaccines from Pfizer and BioNTech, applicants for mixed mRNA vaccines from Pfizer and BioNTech that oppose flu and COVID-19. 19 or any other potential vaccine or product candidate and the uncertainties related to the announcement have an effect on such recommendations; interruptions in appointments between us and our collaboration partners, clinical trial sites or third-party providers, adding our appointments with BioNTech; the risk that we may not be able to effectively develop further vaccine formulations or combination vaccines; the effect of COVID-19 on Pfizer’s business, operations and financial effects; and competitive progressions.
About BioNTech Biopharmaceutical New Technologies (BioNTech) is a global next-generation immunotherapy company pioneering new treatments for cancer and other serious diseases. BioNTech leverages a broad diversity of curative drug discovery and informatics platforms for the immediate progression of new biopharmaceutical products. Its broad pipeline of oncology product applicants includes commercially available, individualized mRNA-based therapeutics, next-generation chimeric antigen receptor (CAR) T cells, and several protein-based therapeutics that add endpoint modulators. bispecific immune controls, targeted anticancer antibodies and antibody-drug conjugates. (ADC), as well as small molecules. Drawing on its deep expertise in mRNA vaccine advancement and in-house production capabilities, BioNTech and its collaborators are fielding applicants for mRNA vaccines for a variety of infectious diseases, alongside its diverse oncology portfolio. BioNTech has established a wide range of relationships with several global and specialty pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a component of the Roche group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
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 collaboration between BioNTech and Pfizer, including adding Pfizer’s investigational modified RNA (modRNA) vaccine applicants, prospective next-generation mRNA influenza vaccine formulations and mixtures, as well as Pfizer and BioNTech’s mRNA mixture vaccine candidate for influenza and COVID -19, and mRNA technology; qualitative evidence of available knowledge and expectations of potential benefits; regulatory filings and regulatory approvals or authorizations and expectations related to production, distribution and supply; expectations related to expected adjustments in vaccine demand, adding adjustments to the ordering environment; and expected regulatory recommendations to adapt vaccines to respond to new strains, 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; uncertainties related to potential next-generation influenza and mRNA mixture vaccine formulations and Pfizer and BioNTech’s mRNA mixture vaccine candidate for influenza and COVID-19, adding whether those applicants will move to long-term studies or progression phases, and when; long-term advertising demand and medical demand for a mixed mRNA vaccine candidate against influenza and COVID-19; the availability of raw materials to manufacture a vaccine; vaccine formulation, dosing schedule and relevant storage, distribution and management requirements, adding relevant hazards related to storage and handling after delivery; festival of other or similar vaccines 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, convenience of storage and distribution, scope of approved use, the effect profile aspect and duration of the immune response; 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; unexpected protection issues and potential allegations arising from the use of products and product applicants developed or manufactured through BioNTech and/or its collaborators; The ability of BioNTech and its collaborators to advertise and advertise products and, if approved, 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 its production capabilities well; similar dangers to the global monetary formula and market positions; 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, 2024, as well as in BioNTech’s upcoming filings with the SEC, which will be available on the SEC’s website. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any purpose or duty to update or revise any forward-looking statements contained in this press release as a result of new information, long-term developments or otherwise.
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1 Burden of influenza-related illness. Centers for Disease Control and Prevention. Available in https://www. cdc. gov/flu/about/burden/index. html2 Putri et al, Vaccine. June 22, 2018; 36(27):3960-3966. doi: 10. 1016/j. vaccine. 2018. 05. 0573 Influenza and people 65 years of age and older. Centers for Disease Control and Prevention. Available in: Flu and others 65 years and older. | CDC4 Vaccine Effectiveness: How Well Do Flu Vaccines Work?Centers for Disease Control and Prevention. Available at https://www. cdc. gov/flu/vaccines-work/vaccineeffect. htm. 5 Disparities in Influenza Among Racial and Ethnic Minority Groups CDC . Available in https://www. cdc. gov/flu/highrisk/disparities-racial-ethnic-minority-groups. html.