Skip directly to content

Pfizer and BioNTech Start Human Trials as Part of Global COVID-19 Vaccine Development Programme

14/05/20
 
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) recently announced that the first participants have been dosed in the U.S. in the clinical trial for the BNT162 vaccine programme to prevent COVID-19. The trial is part of a global development programme with the dosing of the first cohort in Germany completed last week.

 

Pfizer and BioNTech are studying four mRNA vaccine candidates as part of this Phase 1/2 clinical trial. The study is designed to determine the safety, immunogenicity and optimal dose level of the vaccine candidates evaluated in a single, continuous study.

The first stage of the clinical trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age). The first subjects immunised in Stage 1 (the dose level escalation portion of the Phase 1/2 trial) will be healthy adults 18-55 years of age.

Older adults will only be immunised with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity. Sites currently dosing participants include NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center to begin enrollment shortly.

The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19."

Dr. Albert Bourla, Chairman and CEO, Pfizer

Pfizer and BioNTech’s development programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The design of the trial allows for the evaluation of the various mRNA candidates simultaneously. This approach should help to identify the most promising candidate to evaluate in a greater number of volunteers, if it shows enough potential, and in a manner that will facilitate the sharing of data with regulatory authorities in real time.

During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

Pfizer and BioNTech are also preparing to scale up production should a vaccine be successfully developed. Pfizer plans to activate its extensive manufacturing network to produce an approved COVID-19 vaccine in support of the global effort to deliver as quickly as possible for those most in need. The breadth of this programme should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.

Pfizer-owned sites in three U.S. states (Massachusetts, Michigan and Missouri) and Puurs, Belgium have been identified as manufacturing centres for COVID-19 vaccine production, with more sites to be selected. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity to provide further capacities for a global supply of the potential vaccine.

Should BioNTech and Pfizer’s partnership to develop a vaccine for COVID-19 be successful, the two companies will work together to commercialise the vaccine worldwide upon regulatory approval (excluding China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialisation).

 

Understanding mRNA Vaccines

 

 

For all media enquiries, please contact:

Pfizer UK press office
Tel: 0845 300 8033
Email: pressofficeUK@pfizer.com

 

About Pfizer: Breakthroughs that change patients’ lives

 

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

To learn more, please follow us on TwitterInstagram and like us on Facebook.

 

Pfizer Disclosure Notice

 

The information contained in this release is as of May 5, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, BioNTech’s mRNA vaccine program, BNT162, a collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine and manufacturing capacity, including their potential benefits, and the expected timing of clinical trials and potential supply, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any biologics license applications may be filed in any jurisdictions for any potential vaccine candidates under the collaboration; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such vaccine candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities regarding any such vaccine candidates and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “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 of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov.

 

Related articles:

 

Find out more about Pfizer's global efforts in response to the COVID-19 pandemic.

 

The companies have agreed to a letter of intent regarding the co-development and distribution of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection.

PP-PFE-GBR-2574 / May 2020