- The updated vaccine (XBB.1.5 variant-adapted monovalent
COVID-19 vaccine) is now authorized in
Canada for individuals 6 months of
age and older
- The updated 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, QC and MAINZ, Germany, Sept. 28,
2023 /CNW/ - 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 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 Canada
Pfizer 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 Statements
This 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 Affairs
1-866-9-PFIZER (1 866 973-4937)
corporate.affairs.canada@pfizer.com
BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
_______________________________
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1 vi 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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SOURCE Pfizer Canada Inc.