- U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA
vaccine for emergency supply under Regulation 174; Companies are
ready to deliver the first doses to the U.K. immediately
- First authorization for a COVID-19 vaccine represents a
breakthrough scientific achievement to help combat this devastating
pandemic
- The companies previously signed an agreement to supply a total
of 40 million doses to the U.K. with delivery in 2020 and 2021
- U.S. FDA and EU EMA decisions on authorization are expected in
December
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced
today that the Medicines & Healthcare Products Regulatory
Agency (MHRA) in the U.K. has granted a temporary authorization for
emergency use for their COVID-19 mRNA vaccine (BNT162b2), against
COVID-19. This constitutes the first Emergency Use Authorization
following a worldwide Phase 3 trial of a vaccine to help fight the
pandemic. Pfizer and BioNTech are anticipating further regulatory
decisions across the globe in the coming days and weeks and are
ready to deliver vaccine doses following potential regulatory
authorizations or approvals. The distribution of the vaccine in the
U.K. will be prioritized according to the populations identified in
guidance from the Joint Committee on Vaccination and Immunisation
(JCVI).
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the full release here:
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“Today’s Emergency Use Authorization in the U.K. marks a
historic moment in the fight against COVID-19. This authorization
is a goal we have been working toward since we first declared that
science will win, and we applaud the MHRA for their ability to
conduct a careful assessment and take timely action to help protect
the people of the U.K.,” said Albert Bourla, Chairman and Chief
Executive Officer, Pfizer. “As we anticipate further authorizations
and approvals, we are focused on moving with the same level of
urgency to safely supply a high-quality vaccine around the world.
With thousands of people becoming infected, every day matters in
the collective race to end this devastating pandemic.”
“The Emergency Use Authorization in the U.K. will mark the first
time citizens outside of the trials will have the opportunity to be
immunized against COVID-19,” said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech. “We believe that the roll-out of the
vaccination program in the U.K. will reduce the number of people in
the high-risk population being hospitalized. Our aim is to bring a
safe and effective vaccine upon approval to the people who need it.
The data submitted to regulatory agencies around the world are the
result of a scientifically rigorous and highly ethical research and
development program.”
The MHRA’s decision is based on a rolling submission, including
data from the Phase 3 clinical study, which demonstrated a vaccine
efficacy rate of 95% (p<0.0001) 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 first primary objective analysis is based on 170
cases of COVID-19, as specified in the study protocol. Efficacy was
consistent across age, gender, race and ethnicity demographics,
with an observed efficacy in adults age 65 and over of more than
94%. In the trial, BNT162b2 was generally well tolerated with no
serious safety concerns reported by the Data Monitoring Committee
to date. Today’s decision also is based on a review of Pfizer’s and
BioNTech’s Chemistry, Manufacturing and Control (CMC) data for
BNT162b2.
In July 2020, Pfizer and BioNTech announced an agreement with
the U.K. to supply 30 million doses of the BNT162b2 mRNA-based
vaccine, once authorized for emergency use. That agreement was
increased to 40 million doses in early October. The delivery of the
40 million doses will occur throughout 2020 and 2021, in stages, to
ensure an equitable allocation of vaccines across the geographies
with executed contracts. Now that the vaccine is authorized in the
U.K., the companies will take immediate action to begin the
delivery of vaccine doses. The first doses are expected to arrive
in the U.K. in the coming days, with complete delivery fulfilment
expected in 2021.
The companies have filed a request for Emergency Use
Authorization with the U.S. Food and Drug Administration (FDA) and
have submitted the final Conditional Marketing Authorization
Application (CA) following rolling submissions with the European
Medicines Agency (EMA) and several other regulatory agencies around
the world.
Manufacturing and Delivery Capabilities
Pfizer and BioNTech continue to work in collaboration with
governments and Ministries of Health around the world that will
distribute the vaccine, subject to country authorization or
approval, to help ensure it can reach those most in need as quickly
as possible. The companies are leveraging leading vaccine
manufacturing and distribution capabilities to quickly scale,
manufacture and distribute large quantities of the vaccine at high
quality, complementing the mRNA manufacturing expertise of BioNTech
gained over almost a decade. Pfizer has a 171-year track record of
researching, developing, manufacturing and delivering innovative
medicines and vaccines to patients in need. Pfizer and BioNTech are
confident in their ability to safely and effectively deliver the
vaccine to the people in the U.K. Based on current projections,
Pfizer’s and BioNTech’s combined manufacturing network has the
potential to supply globally up to 50 million vaccine doses in 2020
and up to 1.3 billion doses by the end of 2021 (subject to
manufacturing capacity and regulatory approval or
authorization).
Through its existing mRNA production sites in Mainz and
Idar-Oberstein, Germany, BioNTech is able to produce mRNA for
commercial supply after having already produced the vaccine
candidate doses for the clinical trials. BioNTech will also
increase its manufacturing capacity in 2021, once a third site in
Germany will start manufacturing to provide further capacities for
a global supply of the potential vaccine. Critical to distribution
in the U.K. will be Pfizer’s manufacturing site in Puurs, Belgium,
one of Pfizer’s largest sterile injectable sites. The Puurs site is
being used primarily for European supply but will also serve as
back up supply to Kalamazoo, Michigan, for the U.S. market.
Pfizer has vast experience and expertise in cold-chain shipping
and has an established infrastructure to supply the vaccine
worldwide, including distribution hubs that can store vaccine doses
for up to six months. The company’s distribution is built on a
flexible just-in-time system that can ship the frozen vials quickly
to designated points of vaccination at the time of need. So, this
will minimize the need for long term storage anywhere. Vaccination
in a pandemic situation is expected to be rapid, with high demand,
and we do not expect that the product will need to be stored at any
location for more than 30 days.
To assure product quality, the companies have developed
specially designed, temperature-controlled shippers for the
BNT162b2 vaccine candidate, which can maintain recommended storage
conditions (-70°C ±10°C) for extended periods of time without any
additional equipment but dry ice. The shipper can maintain
temperature for 10 days unopened which allows for transportation to
markets globally. Once open, a vaccination center may use the
specially designed shippers as a temporary storage solution to
maintain the recommended storage conditions (-70°C ±10°C) up to 30
days with re-icing every five days in accordance with the handling
instructions. Each shipper contains a GPS-enabled thermal sensor to
track the location and temperature of each vaccine shipment 24
hours a day, seven days a week. Once thawed, the vaccine vial can
be stored for up to five days at refrigerated (2-8°C)
conditions.
From the start of the research program earlier this year, Pfizer
and BioNTech have successfully supplied and distributed their
investigational vaccine to more than 150 clinical trial sites
across the U.S., as well as Europe, Latin America and South Africa
reaching approximately 44,000 participants. Based on their
collective experience, the companies believe in their capability to
distribute the vaccine globally upon approval or authorization.
BioNTech will hold the regulatory authorization in the U.K., and,
if granted, in the U.S., the EU, Canada and other countries. Pfizer
will have the commercialization right worldwide with the exception
of China, Germany and Turkey.
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 2,
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, a temporary authorization for
emergency use in the U.K., regulatory submissions, including a
pending request for Emergency Use Authorization in the U.S. and
rolling submissions with the EMA and several other regulatory
agencies around the world, the anticipated timing of regulatory
submissions, regulatory approvals or authorizations and anticipated
manufacturing, distribution and 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 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 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 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 any other
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 applications
that may be pending or filed for BNT162b2 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; whether and when the U.K. temporary use
authorization may be superseded by the grant of a Marketing
Authorisation; 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.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 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 marketing approval or Emergency Use
Authorization; the timing for submission of manufacturing data to
the FDA; our contemplated shipping and storage plan, including our
estimated product shelf life at various temperatures; 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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Pfizer Contacts:
Media Relations Andy Widger +44 7970 149098
andrew.widger@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media Relations Jasmina Alatovic +49 89 62 81 75 46
Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084
1074 Investors@biontech.de
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