- European Union orders 100 million additional doses of
COMIRNATY® bringing total doses to 300 million for 27 EU member
states
- All 300 million doses expected to be delivered in 2020 and
2021
NEW YORK and MAINZ, GERMANY, December 29,
2020 (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
Advanced Purchase Agreement signed on November 11, 2020. This
agreement brings the total number of doses to be delivered to the
EU to 300 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 spread at an alarming rate.”
said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “In partnership with the European Commission, member
states and healthcare providers, we will be able to reach a total
of 150 million Europeans across the continent.”
“The additional 100 million doses will be
delivered in 2021 supporting the vaccination campaigns which
started two days ago in all 27 member states. Our goal remains to
bring a safe and effective COVID-19 vaccine to as many people as we
can all around the world,” said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech.
COMIRNATY, will be produced in BioNTech’s and
Pfizer’s manufacturing sites in Europe. The distribution of
COMIRNATY by the EU member states will continue to be determined
according to the populations identified in EU and national
guidance. Pfizer and BioNTech announced on November 11, 2020, that
they reached an agreement with the European Commission to supply
200 million, with an option for the European Commission to request
an additional 100 million doses. The companies previously stated
their potential to supply up to 1.3 billion doses worldwide by the
end of 2021 (subject to manufacturing capacity).
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 included pain
at the injection site (84.1%), fatigue (62.9%), headache (55.1%),
muscle pain (38.4%), chills (31.9%) joint pain (23.6%), fever
(14.2%), injection site swelling (10.5%), injection site redness
(9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy
(0.3%)
- 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.
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’ LivesAt 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 29, 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 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, an agreement with the European Commission
and the timing of delivery of doses thereunder, 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 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 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 any other biologics license and/or emergency use
authorization applications may be filed in particular jurisdictions
for BNT162b2 or any other potential vaccines; whether and when any
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’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, 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 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
our vaccine, which would negatively impact our ability to supply
the estimated numbers of doses of our vaccine 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 StatementsThis 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 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.
Pfizer Contacts:
Media Relations Andy Widger+44 (0)1737 330909
eupress@pfizer.com
Investor Relations Chuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media RelationsJasmina Alatovic+49 89 62 81 75
46 Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
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