Novavax Announces Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine
17 December 2020 - 11:07AM
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced an Advance Purchase Agreement with the
government of New Zealand for the purchase of 10.7 million doses of
NVX-CoV2373, Novavax’ candidate vaccine against COVID-19.
Currently in Phase 3 clinical testing in the
United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a
recombinant protein vaccine adjuvanted with Novavax’ proprietary
Matrix-M™ to enhance the immune response.
“The global reach of the pandemic requires that
all regions of the world have an adequate supply of vaccine
available to protect their entire citizenry,” said Stanley C. Erck,
President and Chief Executive Officer of Novavax. “We appreciate
the confidence of the government of New Zealand and are pleased to
contribute to ensuring that New Zealanders will have access to a
protein-based vaccine through standard distribution channels,
should it receive regulatory approval.”
Under the terms of the agreement, Novavax will
manufacture NVX-CoV2373 with a target of delivering initial doses
by mid-2021. The company will work with Medsafe, New Zealand’s
regulatory agency, to obtain product approvals as needed. Given the
urgency of timely approval and delivery of vaccine during the
pandemic, the regulatory review process may leverage review by
prioritized regulatory bodies such as the U.S. Food and Drug
Administration, European Medicines Agency and/or Medicines and
Healthcare products Regulatory Authority in the United Kingdom.
Additional terms of the agreement were not
disclosed.
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 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.
NVX-CoV2373 was generally well-tolerated and elicited robust
antibody responses numerically superior to that seen in human
convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is
being evaluated in an ongoing Phase 3 trial in the U.K. and two
ongoing Phase 2 studies that began in August: a Phase 2b trial in
South Africa, 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 late-stage
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:
Investors
Erika Trahan
ir@novavax.com
240-268-2022
Media
Edna Kaplan
media@novavax.com
617-974-8659
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