First participants dosed at NYU Grossman School
of Medicine and University of Maryland School of Medicine
Pfizer and BioNTech ramping up manufacturing
capabilities to further increase production capacity in
2020/2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced
today that the first participants have been dosed in the U.S. in
the Phase 1/2 clinical trial for the BNT162 vaccine program to
prevent COVID-19. The trial is part of a global development
program, and the dosing of the first cohort in Germany was
completed last week.
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The Phase 1/2 study is designed to determine the safety,
immunogenicity and optimal dose level of four mRNA vaccine
candidates evaluated in a single, continuous study. The dose level
escalation portion (Stage 1) of the Phase 1/2 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 immunized in Stage 1 of
the study will be healthy adults 18-55 years of age. Older adults
will only be immunized 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.
“With our unique and robust clinical study program underway,
starting in Europe and now the U.S., we look forward to advancing
quickly and collaboratively with our partners at BioNTech and
regulatory authorities to bring a safe and efficacious vaccine to
the patients who need it most. 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,”
said Albert Bourla, Chairman and CEO, Pfizer.
Pfizer and BioNTech’s development program includes four vaccine
candidates, each representing a different combination of mRNA
format and target antigen. The novel design of the trial allows for
the evaluation of the various mRNA candidates simultaneously in
order to identify the safest and potentially most efficacious
candidate in a greater number of volunteers, in a manner that will
facilitate the sharing of data with regulatory authorities in real
time.
“It is encouraging that we have been able to leverage more than
a decade of experience in developing our mRNA platforms to initiate
a global clinical trial in multiple regions for our vaccine program
in such a short period. We are optimistic that advancing multiple
vaccine candidates into human trials will allow us to identify the
safest, most effective vaccination options against COVID-19,” said
CEO and Co-founder of BioNTech, Ugur Sahin.
During the clinical development stage, BioNTech will provide
clinical supply of the vaccine from its GMP-certified mRNA
manufacturing facilities in Europe.
In anticipation of a successful clinical development program,
Pfizer and BioNTech are working to scale up production for global
supply. Pfizer plans to activate its extensive manufacturing
network and invest at risk in an effort to produce an approved
COVID-19 vaccine as quickly as possible for those most in need
around the world. The breadth of this program 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 centers 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.
BioNTech and Pfizer will work jointly to commercialize the
vaccine worldwide upon regulatory approval (excluding China, where
BioNTech has a collaboration with Fosun Pharma for BNT162 for both
clinical development and commercialization).
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 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on 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 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 and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a next
generation immunotherapy company pioneering novel therapies for
cancer and other serious diseases. The Company exploits a wide
array of computational discovery and therapeutic drug platforms for
the rapid development of novel biopharmaceuticals. Its broad
portfolio of oncology product candidates includes individualized
and off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Eli Lilly and Company, Genmab, Sanofi,
Bayer Animal Health, Genentech, a member of the Roche Group,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.de.
BioNTech Forward-looking statements
This press release contains “forward-looking statements” of
BioNTech within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements may include,
but may not be limited to, statements concerning: BioNTech’s
efforts to combat COVID-19; the timing to initiate clinical trials
of BNT162; collaborations between BioNTech and Pfizer, and BioNTech
and Fosun Pharma, to develop a potential COVID-19 vaccine; and the
ability of BioNTech to supply the quantities of BNT162 to support
clinical development and, if approved, market demand. Any
forward-looking statements in this press release are based on
BioNTech current expectations and beliefs of future events, and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to: competition to
create a vaccine for Covid-19 and potential difficulties. For a
discussion of these and other risks and uncertainties, see
BioNTech’s Annual Report on Form 20-F filed with the SEC on March
31, 2020, which has been filed with the SEC and is available on the
SEC’s website at www.sec.gov. All information in this press release
is as of the date of the release, and BioNTech undertakes no duty
to update this information unless required by law.
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Pfizer Contacts Media Relations Amy Rose +1 (212)
733-7410 amy.rose@pfizer.com Investor Relations Chuck Triano +1
(212) 733-3901 Charles.E.Triano@Pfizer.com BioNTech Contacts
Media Relations Jasmina Alatovic Senior Manager Global External
Communications +49 (0)6131 9084 1513 or +49 (0)151 1978 1385
Media@biontech.de Investor Relations Sylke Maas, Ph.D. VP Investor
Relations & Business Strategy +49 (0)6131 9084 1074
Investors@biontech.de
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