- COMIRNATY Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
is now authorized in Canada for individuals 6 months of age and
older
- New Omicron XBB.1.5-adapted COVID-19 vaccine is administered as
a single dose for individuals 5 years of age and older, regardless
of COVID-19 vaccination history. In children 6 months through 4
years of age the vaccine is administered as a three-dose series in
those without a history of completion of a COVID-19 primary
vaccination course, or as a single dose in those with a history of
completion of a COVID-19 primary vaccination course
- The updated vaccine is expected to be available in Canada in
the coming weeks
KIRKLAND, QUEBEC and MAINZ, GERMANY,
September 28, 2023 — Pfizer Canada ULC and BioNTech SE (Nasdaq:
BNTX, “BioNTech”) announced today that Health Canada has authorized
the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
(COMIRNATY® Omicron XBB.1.5) for ages 6 months and older. The
updated vaccine will be available in Canada as a single dose for
individuals 5 years of age and older, regardless of prior COVID-19
vaccination history. For children 6 months through 4 years of age
the updated vaccine is authorized for administration as a
three-dose series in those without a history of completion of a
COVID-19 primary vaccination course, or as a single dose for those
with a history of completion of a COVID-19 primary vaccination
course.
The authorization of is based on the full body
of previous clinical, non-clinical, and real-world evidence
supporting the safety and efficacy of the Pfizer-BioNTech COVID-19
Vaccines. Further, the application included pre-clinical data on
the neutralization potential of serum antibodies induced by the
updated monovalent COVID-19 vaccine against multiple XBB-related
sublineages, including XBB.1.5, XBB.1.16, XBB.2.3 and EG.5.1
(Eris).
Pfizer and BioNTech continue to monitor emerging
SARS-CoV-2 strains and continue to conduct studies to monitor the
vaccine’s effectiveness, including the recently emerged Omicron
BA.2.86 (Pirola) variant and the globally dominant EG.5.1 (Eris)
subvariant.1 “With today’s Health Canada authorization, individuals
6 months and older in Canada are eligible to receive the
XBB.1.5-adapted COVID-19 vaccine, even if they have never been
vaccinated against COVID-19 before,” said Andréa Mueller, Primary
Care Portfolio Lead, Pfizer Canada. “We are proud of this
achievement that empowers Canadians to protect themselves against
the XBB sublineages, which are currently the most dominant strains
in Canada. We expect the newly formulated vaccine to be available
in Canada in the coming weeks to ensure people can get their
updated COVID-19 vaccine ahead of the fall/winter season when
respiratory viruses are expected to peak.”
“As COVID 19 is expected to become a seasonal
disease, similar to influenza, it remains our goal to provide
COVID-19 vaccines that are adapted to the respective circulating
virus variants or sublineages to the people worldwide,” said Prof.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The new
variant-adapted monovalent vaccine aims to further improve
protection against severe illness and hospitalization caused by
Omicron XBB descendent sublineages that are antigenically distant
from prior Omicron strains.”
The COVID-19 vaccines (COMIRNATY®) by Pfizer and
BioNTech are based on BioNTech’s proprietary mRNA technology and
were developed by both companies. BioNTech is the Marketing
Authorization Holder for COMIRNATY and its adapted vaccines
(COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron
BA.4/BA.5; COMIRNATY Omicron XBB.1.5) in the United States, the
European Union, the United Kingdom, Canada and other countries, and
the holder of emergency use authorizations or equivalents in the
United States (jointly with Pfizer) and other countries.
About Pfizer CanadaPfizer Canada ULC is
the Canadian operation of Pfizer Inc., one of the world's leading
biopharmaceutical companies. Our diversified healthcare portfolio
includes some of the world's best known and most prescribed
medicines and vaccines. We apply science and our global resources
to improve the health and well-being of Canadians at every stage of
life. Our commitment is reflected in everything we do, from our
disease awareness initiatives to our community partnerships. To
learn more about Pfizer Canada, visit pfizer.ca or you
can follow us
on LinkedIn, Facebook, Twitter or YouTube.
About BioNTech Biopharmaceutical New
Technologies (BioNTech) 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 (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as 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 DualityBio, Fosun
Pharma, Genentech, a member of the Roche Group, Genevant, Genmab,
OncoC4, Regeneron, Sanofi, and Pfizer.
For more information, please visit
www.BioNTech.com.
BioNTech Forward-Looking StatementsThis
press release may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not be limited to, statements
concerning: BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer; the rate and degree of
market acceptance of BioNTech’s COVID-19 vaccine, including the
Omicron XBB.1.5-adapted monovalent COVID-19 vaccine; qualitative
assessments of available data and expectations of potential
benefits; regulatory submissions and regulatory approvals or
authorizations and expectations regarding manufacturing,
distribution and supply; expectations regarding anticipated changes
in COVID-19 vaccine demand, including changes to the ordering
environment; and expected regulatory recommendations to adapt
vaccines to address new variants or sublineages. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain
these words. The forward-looking statements in this press release
are neither promises nor guarantees, and you should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond BioNTech’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements. These risks and uncertainties
include, but are not limited to: BioNTech's pricing and coverage
negotiations with governmental authorities, private health insurers
and other third-party payors after BioNTech's initial sales to
national governments; the future commercial demand and medical need
for initial or booster doses of a COVID-19 vaccine; competition
from other COVID-19 vaccines or related to BioNTech's other product
candidates, including those with different mechanisms of action and
different manufacturing and distribution constraints, on the basis
of, among other things, efficacy, cost, convenience of storage and
distribution, breadth of approved use, side-effect profile and
durability of immune response; the timing of and BioNTech's ability
to obtain and maintain regulatory approval for BioNTech's product
candidates; the ability of BioNTech’s COVID-19 vaccines to prevent
COVID-19 caused by emerging virus variants; BioNTech's and its
counterparties’ ability to manage and source necessary energy
resources; BioNTech's ability to identify research opportunities
and discover and develop investigational medicines; the ability and
willingness of BioNTech's third-party collaborators to continue
research and development activities relating to BioNTech's
development candidates and investigational medicines; the impact of
the COVID-19 pandemic on BioNTech's development programs, supply
chain, collaborators and financial performance; unforeseen safety
issues and potential claims that are alleged to arise from the use
of BioNTech's COVID-19 vaccine and other products and product
candidates developed or manufactured by BioNTech; BioNTech's and
its collaborators’ ability to commercialize and market BioNTech's
COVID-19 vaccine and, if approved, its product candidates;
BioNTech's ability to manage its development and expansion;
regulatory developments in the United States and other countries;
BioNTech's ability to effectively scale BioNTech's production
capabilities and manufacture BioNTech's products, including
BioNTech's target COVID-19 vaccine production levels, and
BioNTech's product candidates; risks relating to the global
financial system and markets; and other factors not known to
BioNTech at this time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech’s Report on
Form 6-K for the period ended June 30, 2023 and in subsequent
filings made by BioNTech with the U.S. Securities and Exchange
Commission (“SEC”), which are available on the SEC’s website at
www.sec.gov. Except as required by law, BioNTech disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on BioNTech’s current
expectations and speak only as of the date hereof.
CONTACTS
Pfizer:Pfizer Canada Corporate
Affairs1-866-9-PFIZER (1 866 973-4937)
corporate.affairs.canada@pfizer.com
BioNTech:Media RelationsJasmina
Alatovic+49 (0)6131 9084 1513 Media@biontech.de
Investor Relations Victoria Meissner, M.D. +1 617 528 8293
Investors@biontech.de
1 World Health Organization. EG.5 Initial Risk Evaluation, 9
August 2023. Available at:
https://www.who.int/docs/default-source/coronaviruse/09082023eg.5_ire_final.pdf?sfvrsn=2aa2daee_1
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