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December 10, 2020
NEW YORK &
MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that
the U.S. Food and Drug Administration’s (FDA) Vaccines and Related
Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of
the FDA granting Emergency Use Authorization (EUA) for the companies’
COVID-19 mRNA vaccine (BNT162b2). There is one member of the Committee
whose vote is not included in the 17 to 4 vote decision.
VRBPAC based its
recommendation on the totality of scientific evidence shared by the
companies, including data from a pivotal Phase 3 clinical study announced last month and published today
in The New England Journal of
Medicine.
The Phase 3 data demonstrated a vaccine efficacy rate of 95% in
participants without prior SARS-CoV-2 infection (first primary objective)
and also in participants with and without prior SARS-CoV-2 infection
(second primary objective), in each case measured from 7 days after the
second dose. The Data Monitoring Committee for the study has not reported
any serious safety concerns related to the vaccine. Efficacy was consistent
across age, gender, race and ethnicity demographics. All trial participants
will continue to be monitored for an additional two years after their
second dose to assess long-term protection and safety. The FDA will take
the advisory committee’s recommendation into consideration when it makes a
final determination.
“We have been
looking forward to presenting our robust data package to the committee of
vaccine experts for the U.S. government since we began our efforts to
develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert
Bourla, Pfizer Chairman and CEO. “We are pleased with the committee’s
strong majority vote, and if the FDA issues an authorization, stand at the
ready to bring this vaccine to people in the U.S. in an effort to help
combat this devastating pandemic.”
“I would like to
thank the FDA’s advisory committee for recognizing the critical role that
our vaccine may play in helping to address this ongoing pandemic. Today’s
positive discussion and vote reinforces the potential of our COVID-19
vaccine candidate in helping to protect people against this deadly and
devastating disease,” said Ugur Sahin, CEO and Co-founder of BioNTech.
FDA Advisory
Committees provide non-binding recommendations, with the final decision on
approval or authorization to be made by the FDA. Under an EUA, the FDA has
the authority to allow unapproved medical products or unapproved uses of
approved medical products to be used in an emergency to diagnose, treat, or
prevent serious or life-threatening diseases or conditions during a
declared public health emergency when there are no adequate, approved, and
available alternatives.
About the Phase
2/3 Study
The ongoing Phase
3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA
technology, has enrolled more than 44,000 participants, the vast majority
of whom have received their second dose. A breakdown of the diversity of
clinical trial participants can be found here from more than 150 clinical trials
sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina.
The Phase 3 trial
is designed as a 1:1 vaccine candidate to placebo, randomized,
observer-blinded study to obtain safety, immune response, and efficacy data
needed for regulatory review. The trial’s primary endpoints are prevention
of COVID-19 in those who have not been infected by SARS-CoV-2 prior to
immunization, and prevention of COVID-19 regardless of whether participants
have previously been infected by SARS-CoV-2. Secondary endpoints include
prevention of severe COVID-19 in those groups. The study also will explore
prevention of infection by SARS-CoV-2, the virus that causes COVID-19.
Data from this
study, including longer term safety, comprehensive information on duration
of protection, efficacy against asymptomatic SARS-CoV-2 infection, and
safety and immunogenicity in adolescents 12 to 17 years of age will be
gathered in the months ahead. Additional studies are planned to evaluate
BNT162b2 in pregnant women, children younger than 12 years, and those in
special risk groups, such as the immunocompromised.
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 December 10, 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 qualitative assessments of available data,
potential benefits, expectations for clinical trials, the request for
Emergency Use Authorization in the U.S. and other regulatory submissions,
the anticipated timing of regulatory submissions, regulatory approval or
authorization and anticipated manufacturing, distribution and supply)
involving 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 clinical data
(including the Phase 3 data), including the possibility of unfavorable new
preclinical or clinical trial data and further analyses of existing
preclinical or clinical trial data; the ability to produce comparable
clinical or other results, including the rate of vaccine effectiveness and
safety and tolerability profile observed to date, in additional analyses of
the Phase 3 trial and additional studies or in larger, more diverse
populations upon commercialization; 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 additional 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
any future preclinical and clinical studies; whether and when other biologics
license and/or emergency use authorization applications may be filed in
particular jurisdictions for BNT162b2 or any other potential vaccine
candidates; whether and when the FDA may grant Emergency Use Authorization
for BNT162b2 and whether and when any other applications that may be
pending or filed for BNT162b2 may be approved by particular 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; disruptions in the relationships between us and our
collaboration partners or third-party suppliers; risks related to the
availability of raw materials to manufacture a vaccine; challenges related
to our vaccine candidate’s ultra-low temperature formulation and attendant
storage, distribution and administration requirements, including risks
related to handling after delivery by Pfizer; the risk that we may not be
able to successfully develop non-frozen formulations; the risk that we may
not be able to create or scale up manufacturing capacity on a timely basis
or have access to logistics or supply channels commensurate with global
demand for any potential approved vaccine, which would negatively impact
our ability to supply the estimated numbers of doses of our vaccine
candidate 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; uncertainties regarding the impact of
COVID-19 on Pfizer’s business, operations and financial results; 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.govand 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 collaboration between BioNTech
and Pfizer to develop a potential COVID-19 vaccine; our expectations
regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial
and/or in commercial use based on data observations to date; the expected
timepoint for additional readouts on efficacy data of BNT162b2 in our Phase
2/3 trial; the nature of the clinical data, which is subject to ongoing
peer review, regulatory review and market interpretation; the timing for submission
of data for, or receipt of, any potential Emergency Use Authorization; the
timing for submission of manufacturing data to the FDA; and the ability of
BioNTech to supply the quantities of BNT162 to support clinical development
and, if approved, market demand, including our production estimates for
2020 and 2021. 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: the ability to meet the pre-defined
endpoints in clinical trials; competition to create a vaccine for COVID-19;
the ability to produce comparable clinical or other results, including our
stated rate of vaccine effectiveness and safety and tolerability profile
observed to date, in the remainder of the trial or in larger, more diverse
populations upon commercialization; 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 Quarterly Report
for the Three and Nine Months Ended September 30, 2020, filed as Exhibit
99.2 to its Current Report on Form 6-K filed with the SEC on November 10,
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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