Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced
today that they have submitted an amended protocol to the U.S. Food
and Drug Administration to expand the enrollment of their Phase 3
pivotal COVID-19 vaccine trial to up to approximately 44,000
participants which also allows for the enrollment of new
populations.
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Enrollment in the trial has been proceeding as planned and the
company expects to reach its initial target of up to 30,000
participants next week. The proposed expansion would allow the
companies to further increase trial population diversity, and
include adolescents as young as 16 years of age and people with
chronic, stable HIV (human immunodeficiency viruses), Hepatitis C,
or Hepatitis B infection, as well as provide additional safety and
efficacy data.
The pivotal trial is event-based and there are many variables
that will ultimately impact read-out timing. As stated previously,
based on current infection rates, the companies continue to expect
that a conclusive readout on efficacy is likely by the end of
October.
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. 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 September 12, 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, the collaboration between BioNTech and
Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA
vaccine program, and modRNA candidate BNT162b2 (including
expectations for clinical trials, a proposed amended protocol for
its Phase 3 clinical trial and timing of clinical trial readouts
and regulatory submissions), 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 risks associated
with preliminary data, including the possibility of unfavorable new
preclinical or clinical trial data and further analyses of existing
preclinical or clinical trial data that may be inconsistent with
the data used for selection of the BNT162b2 vaccine candidate and
dose level for the Phase 2/3 study; whether and when the amended
protocol will be approved by the FDA; the risk that clinical trial
data are subject to differing interpretations and assessments,
including during the peer review/publication process, in the
scientific community generally, and by regulatory authorities;
whether and when data from the BNT162 mRNA vaccine program will be
published in scientific journal publications and, if so, when and
with what modifications; whether regulatory authorities will be
satisfied with the design of and results from these and future
preclinical and clinical studies; whether and when any biologics
license and/or emergency use authorization applications may be
filed in any jurisdictions for BNT162b2 or any other potential
vaccine candidates; 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 vaccine
candidate’s benefits outweigh its known risks and determination of
the vaccine candidate’s efficacy and, if approved, whether it 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 a vaccine, including development of products or therapies by
other companies; manufacturing capabilities or capacity, including
whether the estimated numbers of doses can be manufactured within
the projected time periods indicated; whether and when additional
supply agreements will be reached; uncertainties regarding the
ability to obtain recommendations from vaccine technical committees
and other public health authorities 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 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 Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, 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, the size of its clinical trials of BNT162, and
anticipated publication of data from these clinical trials; the
potential safety and efficacy of BNT162; and the collaboration
between BioNTech and Pfizer to develop a potential COVID-19
vaccine. 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; the ability to
produce comparable clinical results in larger and more diverse
clinical trials; the ability to effectively scale our productions
capabilities; and other 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 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 (646)
592-3157 Amy.Rose@Pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts: Media Relations Jasmina Alatovic +49
(0)6131 9084 1513 or +49 (0)151 1978 1385 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084
1074 Investors@biontech.de
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