- COMIRNATY Original & Omicron BA.4/BA.5 now
authorized in Canada as a booster
dose for children 5 through <12 years old
- Authorization is based on clinical, pre-clinical and
manufacturing data for Omicron-adapted bivalent vaccines as well as
data from the companies' original COVID-19 vaccine
- Health Canada's
authorization is for a 10-µg booster dose of COMIRNATY Original
& Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in
children 5 through <12 years of age
KIRKLAND, QC and MAINZ, Germany, Dec. 9, 2022
/CNW/ - Pfizer Canada ULC and BioNTech SE (NASDAQ: BNTX)
("BioNTech") today announced that Health Canada has authorized
COMIRNATY® Original & Omicron BA.4/BA.5 as a 10-μg booster dose
for children 5 through <12 years of age. This booster is
approved for use at least 6 months after completing the primary
course of the companies' original COVID-19 vaccine (COMIRNATY).
The authorization of the bivalent COVID-19 vaccine for children
5 through <12 years of age is supported by safety and
immunogenicity data from the companies' original COVID-19 vaccine,
data from the companies' 30-µg Omicron BA.1-adapted bivalent
vaccine, manufacturing data from the companies' 10-µg Omicron
BA.4/BA.5-adapted bivalent vaccine, and non-clinical and clinical
data from the companies' 30-µg Omicron BA.4/BA.5-adapted bivalent
vaccine.
The Pfizer-BioNTech COVID-19 Vaccines are based on BioNTech's
proprietary mRNA technology and were developed by both BioNTech and
Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2
Original and BNT162b2 Bivalent (Original/Omicron BA.4/BA.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. Submissions to pursue regulatory
approvals in those countries where emergency use authorizations or
equivalent were initially granted are planned.
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 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, Genentech, a member of the
Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For
more information, please visit www.BioNTech.de.
Pfizer Contacts:
Pfizer Canada Corporate Affairs
1-866-9-PFIZER (1 866 973-4937)
corporate.affairs.canada@pfizer.com
BioNTech Contacts:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations:
Sylke
Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
SOURCE Pfizer Canada ULC