- European Union exercises option under previous agreement to
order 100 million additional doses of COMIRNATY®, bringing total
doses to 600 million for 27 EU member states
- All doses expected to be delivered in 2021
NEW YORK and MAINZ, GERMANY, April 19, 2021
(GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced they will supply an additional 100
million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to
the 27 European Union (EU) member states in 2021. This announcement
is a result of the European Commission’s (EC) decision to exercise
its option to purchase an additional 100 million doses under its
expanded Advanced Purchase Agreement signed on February 17, 2021.
This brings the total number of doses to be delivered to the EU to
600 million.
“We remain committed to moving as quickly and
safely as possible to bring this vaccine to more people in Europe,
as the deadly virus continues to wreak havoc across the continent,”
said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “To date, we have met all of our supply commitments to
the EC and we plan to deliver 250 million doses to the European
Union in Q2, a fourfold increase on Q1’s agreed quantity.”
“The additional 100 million doses from this
option exercise will further help to support the acceleration of
the vaccination campaigns throughout the EU. We now intend to
deliver a total of 600 million doses to the EU this year, which
covers two thirds of the EU population and represents the largest
cumulative supply agreement for COMIRNATY that we have agreed to
date globally,” said Sean Marett, Chief Business and Chief
Commercial Officer of BioNTech.
COMIRNATY® will be produced in BioNTech’s and
Pfizer’s manufacturing sites in Europe.
AUTHORIZED USE IN THE EU: COMIRNATY®
▼ (the Pfizer-BioNTech COVID-19 vaccine) has been granted
conditional marketing authorisation by the European Medicines
Agency to prevent coronavirus disease 2019 (COVID-19) in people
from 16 years of age. The European Medicines Agency’s (EMA’s) human
medicines committee (CHMP) has completed its rigorous evaluation of
COMIRNATY®, concluding by consensus that sufficiently robust data
on the quality, safety and efficacy of the vaccine are now
available.
IMPORTANT SAFETY INFORMATION:
- Events of anaphylaxis have been
reported. Appropriate medical treatment and supervision should
always be readily available in case of an anaphylactic reaction
following the administration of the vaccine.
- The efficacy, safety and
immunogenicity of the vaccine has not been assessed in
immunocompromised individuals, including those receiving
immunosuppressant therapy. The efficacy of COMIRNATY® may be lower
in immunosuppressed individuals.
- As with any vaccine, vaccination
with COMIRNATY® may not protect all vaccine recipients. Individuals
may not be fully protected until 7 days after their second dose of
vaccine.
- In clinical studies, adverse
reactions in participants 16 years of age and older were injection
site pain (> 80%), fatigue (> 60%), headache (> 50%),
myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and
injection site swelling (> 10%) and were usually mild or
moderate in intensity and resolved within a few days after
vaccination. A slightly lower frequency of reactogenicity events
was associated with greater age.
- There is limited experience with
use of COMIRNATY® in pregnant women. Administration of COMIRNATY®
in pregnancy should only be considered when the potential benefits
outweigh any potential risks for the mother and fetus.
- It is unknown whether COMIRNATY® is
excreted in human milk.
- Interactions with other medicinal
products or concomitant administration of COMIRNATY® with other
vaccines has not been studied.
- For complete information on the
safety of COMIRNATY® always make reference to the approved Summary
of Product Characteristics and Package Leaflet available in all the
languages of the European Union on the EMA website.
The black equilateral triangle denotes that
additional monitoring is required to capture any adverse reactions.
This will allow quick identification of new safety information.
Individuals can help by reporting any side effects they may get.
Side effects can be reported to EudraVigilance or directly to
BioNTech using email medinfo@biontech.de, telephone +49 6131
9084 0, or via the website www.biontech.de.
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 April 19, 2021. 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 COVID-19
vaccine, the BNT162 mRNA vaccine program and COMIRNATY®, the
Pfizer-BioNTech COVID-19 vaccine (BNT162b2) (including qualitative
assessments of available data, potential benefits, expectations for
clinical trials, supply agreements with the European Commission and
the timing of delivery of doses thereunder, the anticipated timing
of regulatory submissions, regulatory approvals or authorizations
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 preclinical and clinical data (including the
Phase 3 data), including the possibility of unfavorable new
preclinical, clinical or safety data and further analyses of
existing preclinical, clinical or safety 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 following
commercialization; the ability of BNT162b2 to prevent COVID-19
caused by emerging virus variants; the risk that more widespread
use of the vaccine will lead to new information about efficacy,
safety, or other developments, including the risk of additional
adverse reactions, some of which may be serious; the risk that
preclinical and 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 and interpretations; whether regulatory authorities
will be satisfied with the design of and results from these and any
future preclinical and clinical studies; whether and when a
Biologics License Application for BNT162b2 may be filed in the U.S.
and whether and when other biologics license and/or emergency use
authorization applications or amendments to any such applications
may be filed in particular jurisdictions for BNT162b2 or any other
potential vaccines that may arise from the BNT162 program, and if
obtained, whether or when such emergency use authorization or
licenses will expire or terminate; whether and when any
applications that may be pending or filed for BNT162b2 (including a
potential Biologics License Application in the U.S. or any
requested amendments to the emergency use or conditional marketing
authorizations) or other vaccines that may result from the BNT162
program may be approved by particular regulatory authorities, which
will depend on myriad factors, including making a determination as
to whether the vaccine’s benefits outweigh its known risks and
determination of the vaccine’s efficacy and, if approved, whether
it will be commercially successful; decisions by regulatory
authorities impacting labeling or marketing, 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’s ultra-low temperature formulation,
two-dose schedule and attendant storage, distribution and
administration requirements, including risks related to storage and
handling after delivery by Pfizer; the risk that we may not be able
to successfully develop other vaccine formulations; the risk that
we may not be able to create or scale up manufacturing capacity on
a timely basis or maintain access to logistics or supply channels
commensurate with global demand for our vaccine, which would
negatively impact our ability to supply the estimated numbers of
doses of our vaccine within the projected time periods as
previously 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, 2020 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 (COMIRNATY®) 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;
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 Annual Report as Form 20-F for the Year Ended December
31, 2020, filed with the SEC on March 30, 2021, 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.
Pfizer Contacts:
Media Relations
Andy Widger+44 (0)1737 330909
eupress@pfizer.com
Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084
1074Investors@biontech.de
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