Novavax Announces Memorandum of Understanding to Produce COVID-19 Vaccine Made in Canada
February 02 2021 - 12:31PM
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, today
announced memorandum of understanding with the Canadian government
to produce NVX-CoV2373, the Company’s protein-based vaccine
candidate against COVID-19 in Canada.
“Since the beginning of the pandemic, our top
priority has been the health and safety of all Canadians,” said
Prime Minister Justin Trudeau. “Today, we are investing in our
biomanufacturing capacity so that we have the made-in-Canada
vaccines and treatments we need to protect Canadians, now and in
the future, and recover from the impacts of COVID-19.”
“The Canadian government has been diligent in
partnering with Novavax to ensure broad access of our COVID-19
vaccine candidate to the citizens of Canada,” said Stanley C.
Erck, President and Chief Executive Officer of Novavax.
“Establishing a manufacturing foothold in Canada will be an
important step forward in our quest to deliver an urgently needed
safe and effective vaccine.”
Novavax plans to produce its COVID-19 vaccine at
the National Research Council’s Biologics Manufacturing Centre in
Montréal once both the vaccine candidate and the facility receive
Health Canada approvals. The memorandum of understanding also
includes a broader intention for the Government of Canada and
Novavax to work together to increase the company’s Canadian
presence. They will explore a range of partnership opportunities
for Novavax to expand vaccine production in Canada, including
partnerships with Canadian contract manufacturers.
The Government of Canada has previously signed
an agreement with Novavax to provide up to 76 million doses of
Novavax’ COVID-19 vaccine candidate. Novavax recently initiated the
rolling submission process for regulatory approval to Health
Canada.
“Our Government is bringing back the vaccine
manufacturing capacity that Canadians expect and need,” said The
Hon. François-Philippe Champagne, Minister of Innovation, Science
and Industry. “Pursuing domestic manufacturing of Novavax’ COVID-19
vaccine at the National Research Council’s Royalmount facility is
part of our government’s commitment to protect the health and
safety of all Canadians today, and in the future.”
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate
engineered from the genetic sequence of SARS-CoV-2, the virus that
causes COVID-19 disease. NVX-CoV2373 was created using Novavax’
recombinant nanoparticle technology to generate antigen derived
from the coronavirus spike (S) protein and is adjuvanted with
Novavax’ patented saponin-based Matrix-M™ to enhance the immune
response and stimulate high levels of neutralizing antibodies.
NVX-CoV2373 contains purified protein antigen and can neither
replicate, nor can it cause COVID-19. In preclinical studies,
NVX-CoV2373 induced antibodies that block binding of spike protein
to cellular receptors and provided protection from infection and
disease. It was generally well-tolerated and elicited robust
antibody response numerically superior to that seen in human
convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is
currently being evaluated in two pivotal Phase 3 trials: a trial in
the U.K that demonstrated 89.3 percent overall efficacy
and 95.6 percent against the original strain in a post-hoc
analysis, and the PREVENT-19 trial in
the U.S. and Mexico that began in December. It
is also being tested in two ongoing Phase 2 studies that began in
August: A Phase 2b trial in South Africa that demonstrated up
to 60 percent efficacy against newly emerging escape variants, and
a Phase 1/2 continuation in
the U.S. and Australia.
About Matrix-M™
Novavax’ patented saponin-based Matrix-M™
adjuvant has demonstrated a potent and well-tolerated effect by
stimulating the entry of antigen presenting cells into the
injection site and enhancing antigen presentation in local lymph
nodes, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology
company that promotes improved health globally through the
discovery, development and commercialization of innovative vaccines
to prevent serious infectious diseases. The Company’s proprietary
recombinant technology platform combines the power and speed of
genetic engineering to efficiently produce highly immunogenic
nanoparticles designed to address urgent global health needs.
Novavax is conducting late-stage clinical trials for NVX-CoV2373,
its vaccine candidate against SARS-CoV-2, the virus that causes
COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle
vaccine, met all primary objectives in its pivotal Phase 3 clinical
trial in older adults and will be advanced for regulatory
submission. Both vaccine candidates incorporate Novavax’
proprietary saponin-based Matrix-M™ adjuvant to enhance the immune
response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
Novavax Forward Looking
Statements
Statements herein relating to the future
of Novavax and the ongoing development of its vaccine and
adjuvant products are forward-looking
statements. Novavax cautions that these forward-looking
statements are subject to numerous risks and uncertainties, which
could cause actual results to differ materially from those
expressed or implied by such statements. These risks and
uncertainties include those identified under the heading “Risk
Factors” in the Novavax Annual Report on Form 10-K for the year
ended December 31, 2019, and Quarterly Report on
Form 10-Q for the period ended September 30, 2020,
as filed with the Securities and Exchange
Commission (SEC). We caution investors not to place
considerable reliance on forward-looking statements contained in
this press release. You are encouraged to read our filings with
the SEC, available at sec.gov, for a discussion of these
and other risks and uncertainties. The forward-looking statements
in this press release speak only as of the date of this document,
and we undertake no obligation to update or revise any of the
statements. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
Contacts:
InvestorsErika
Trahanir@novavax.com240-268-2022
MediaAmy Speak media@novavax.com617-420-2461
Laura Keenan410-419-5755media@novavax.com
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