Pfizer launches study of next-generation mRNA-based influenza vaccine program

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  • Influenza causes an estimated 5 million cases of serious illness and 290,000 to 650,000 deaths worldwide each year,1 with current seasonal vaccines preventing 40-60% of the disease during the best suited seasons 2
  • The design of mRNA-based vaccines requires only the genetic sequences of the viruses, which allows for more flexible and faster manufacturing and the possibility of improving the efficacy of current influenza vaccines.

NEW YORK – (BUSINESS WIRE) – Pfizer Inc. (NYSE: PFE) today announced that the first participants have been assayed in a Phase 1 clinical trial to assess the safety, tolerability and immunogenicity of a single-dose quadrivalent mRNA vaccine against influenza in healthy adults. Pfizer’s mRNA influenza vaccine program is the first in a planned wave of programs leveraging mRNA technology for influenza. Beyond influenza, the company plans to explore mRNA in other respiratory viruses, including medically appropriate vaccine combinations that could offer protection against more than one respiratory virus, as well as developing for develop mRNA technology in oncology and genetic diseases.

“Since 2018, we have been working on the development of a potential mRNA influenza vaccine, using our in-depth understanding of infectious diseases and our extensive experience in researching, developing and implementing new vaccine technologies to help prevent them, ”said Kathrin U. Jansen, Ph .D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “The COVID-19 pandemic has allowed us to take advantage of the immense scientific opportunity of mRNA. Influenza remains an area where we see a need for vaccines that could improve efficacy in any given season, and we believe mRNA is the ideal technology to address this challenge and transform global health outcomes. ”

Conventional seasonal influenza vaccines are typically developed by growing the virus in chicken eggs or mammalian cells, which are inactivated and made into a vaccine. This process faces multiple challenges, including the production of immunogenic antigens, monitoring of viral strain changes and alterations of vaccine antigens during production. With circulating influenza strains constantly changing, it is difficult for global health experts to predict the best match for next season’s vaccine, as these strains are chosen more than six months before the start of the influenza season. they target in the northern hemisphere.

Even when the vaccine strains match well with circulating influenza virus strains, current seasonal vaccines generally provide 40% to 60% protection against circulating strains, with even lower protection in years when the strains do not match well.3 Influenza causes an estimated 5 million cases of serious illness and up to 650,000 deaths worldwide each year.4

Designing an mRNA-based influenza vaccine requires only the genetic sequence of the virus. The flexibility of mRNA technology and its rapid manufacture could potentially allow for better strain matching, greater reliability of supply, and the possibility of improving the efficacy of current influenza vaccines. In addition, in an influenza pandemic situation, mRNA technology could enable the rapid and large-scale manufacture of effective vaccines.

About the phase 1 study

The randomized phase 1 study will take place in the United States and will begin by evaluating the safety, tolerability and immunogenicity of a single dose of an influenza mRNA vaccine in healthy adults aged 65 and over. at age 85, with an FDA approved standard quadrivalent. influenza vaccine as a control.

Candidate mRNA vaccines will encode strains recommended by the World Health Organization. 5 After the first tests of candidate vaccines encoding individual strains, multivalent combinations should be tested. As the program progresses, strains may be updated based on recommendations for subsequent influenza seasons.

Additional information on the study is available at www.clinicaltrials.gov under the identifier NCT05052697.

In 2018, Pfizer entered into a global collaborative agreement with BioNTech under which Pfizer will conduct the clinical development and commercialization of mRNA-based influenza vaccines. Upon potential approval and commercialization, BioNTech would receive a royalty on Pfizer’s sales.

About Pfizer: Advances That Change Patients’ Lives

At Pfizer, we apply science and our global resources to provide people with therapies that significantly extend and improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health products, including innovative drugs and vaccines. Every day, Pfizer colleagues work in developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most dreaded diseases of our time. In line with our responsibility as one of the world’s leading innovative biopharmaceutical companies, we collaborate with healthcare providers, governments and local communities to support and expand access to reliable and affordable healthcare in the whole world. For more than 150 years, we’ve worked to make a difference for all those who rely on us. We regularly post information that may be important to investors on our website at www.Pfizer.com. Additionally, to find out more, visit us at 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 information contained in this press release is as of September 27, 2021. Pfizer assumes no obligation to update any forward-looking statements contained in this press release as a result of new information or future events or developments.

This release contains forward-looking information on Pfizer’s single-dose quadrivalent influenza vaccine candidate, mRNA technology, and expansion plans to develop mRNA technology in other respiratory viruses, oncology and genetic diseases and to explore medically appropriate combinations to potentially develop vaccines that could provide protection against more than one respiratory virus, including their potential benefits, which involves substantial risks and uncertainties that could cause actual results to differ substantially from those expressed or implied by such statements. Risks and uncertainties include, among others, uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, start and / or completion dates of our clinical trials, dates regulatory submission, regulatory approval dates and / or launch dates, as well as the possibility of new adverse clinical data and further analysis of existing clinical data; the risk that clinical trial data may be subject to different interpretations and evaluations by regulatory authorities; whether regulatory authorities will be satisfied with the design and results of our clinical studies; if and when biologic license applications may be made in any jurisdiction for Pfizer’s mRNA influenza vaccine for any potential indication or for any other potential vaccine or product candidate; whether and when such applications can be approved by regulatory authorities, which will depend on a myriad of factors, including determining whether the benefits of the product outweigh its known risks and determining the effectiveness of the product and, if approved, whether Pfizer’s mRNA influenza vaccine or any other potential vaccine or product candidate will be commercially successful; decisions by regulatory authorities affecting labeling, manufacturing processes, safety and / or other matters that may affect the availability or commercial potential of Pfizer’s influenza mRNA vaccine or any other vaccine or potential product candidate; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding Pfizer mRNA influenza vaccine or any other potential vaccine or product candidate and uncertainties regarding commercial impact of these recommendations; the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A more detailed description of the risks and uncertainties can be found in Pfizer’s annual report on Form 10-K for the year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in sections thereof. herein entitled “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all filed with the United States Securities and Exchange Commission and available at the address www.sec.gov and www.pfizer.com.

1 Flu (seasonal). World Health Organization. Available at https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).

2 Vaccine effectiveness: How well do influenza vaccines work? CDC. Available at https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm.

3 Vaccine effectiveness: How well do influenza vaccines work? CDC. Available at https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm.

4 Influenza (Seasonal). World Health Organization. Available at https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).

5 Recommended composition of influenza virus vaccines for use during the 2021-2022 influenza season in the northern hemisphere. World Health Organization. Available at https://www.who.int/publications/i/item/recommended-composition-of-influenza-virus-vaccines-for-use-in-the-2021-2022-northern-hemisphere-influenza-season.

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Source: Pfizer Inc.



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