Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, today
announced a Memorandum of Understanding (MOU) with Gavi, the
Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of
NVX-CoV2373, Novavax’ recombinant protein-based COVID-19 vaccine
candidate, for the COVAX Facility. The vaccine doses will be
manufactured and distributed globally by Novavax and Serum
Institute of India (SII), the latter under an existing agreement
between Gavi and SII. NVX-CoV2373 is being studied in two ongoing
pivotal Phase 3 clinical trials: in the United States and Mexico,
as well as in the United Kingdom (U.K.), for the prevention of
COVID-19. Novavax has previously reported positive interim efficacy
results from its U.K. trial.
COVAX is the vaccines pillar of the Access to
COVID-19 Tools (ACT) Accelerator, which is co-led by the Coalition
for Epidemic Preparedness Innovations (CEPI), Gavi, and the World
Health Organization (WHO), who are working in partnership with
developed and developing country vaccine manufacturers, UNICEF, the
World Bank, civil society organisations and others to guarantee
fair and equitable access to the vaccine for every country in the
world. COVAX currently includes more than 190 participating
economies.
“We are proud to partner with all the COVAX
collaborators and Serum Institute of India to provide global public
health leadership and ensure that all countries have broad access
to NVX-CoV2373,” said Stanley C. Erck, President and Chief
Executive Officer of Novavax. “Novavax will play a critical role in
the worldwide effort to provide access to safe and effective
vaccines to end the pandemic.”
Gavi leads the design and implementation of the
COVAX Facility and will work with Novavax to finalize an advance
purchase agreement (APA) for vaccine supply and global distribution
allocation via the COVAX Facility and its partners.
“This agreement brings the COVAX Facility one
step closer to its goal of supplying vaccines globally and ending
the acute phase of the pandemic,” said Dr. Seth Berkley, CEO of
Gavi. “It helps us close in on our goal of delivering two billion
doses in 2021 and increases the range of vaccines available to us
as we build a portfolio suitable for all settings and
contexts.”
CEPI has provided critical support to Novavax,
including the commitment of approximately $400 million to advance
early clinical development and manufacturing scale-up in multiple
facilities around the globe. Novavax has created a global supply
network to ensure there can be adequate and equitable supply of
NVX-CoV2373 across the globe. Consistent with its mission to
increase global manufacturing capacity and ensure broad, equitable
supply distribution, Novavax licensed its NVX-CoV2373 technology to
SII with no upfront, milestone or technology transfer payments.
With this strategic partnership in place, Novavax and SII are
jointly committed to deliver 1.1 billion doses to the COVAX
Facility. For supply of NVX-CoV2373 to COVAX, Novavax is expected
to supply doses primarily to high-income countries (HICs), with SII
providing the majority of supply for low-, middle, and
upper-middle-income countries, (LMICs, UMICs), utilizing a tiered
pricing schedule.
“With this MOU in place, the vaccine candidate
developed by our partners at Novavax is poised to play a
significant role in combatting COVID-19 around the world,” said Dr.
Richard Hatchett, CEO of CEPI. “CEPI’s investments in this
vaccine have been pivotal to enabling equitable access to a
significant volume of this vaccine through COVAX.”
“We are pleased to deepen our partnership with
Novavax and COVAX to increase the doses of vaccine available to
benefit humanity,” said Adar Poonawalla, Chief Executive Officer,
Serum Institute of India.” This global collaboration is vital to
ensure that the largest possible amount of vaccine is available to
reach individuals across the broadest segment of countries.
NVX-CoV2373 was the first vaccine
to demonstrate clinical efficacy against the original
strain of COVID-19 and both of the rapidly emerging variants in
the United Kingdom and South Africa. NVX-CoV2373 can
neither cause COVID-19 nor can it replicate. It is shipped in a
ready-to-use liquid formulation. Because it is stable at 2°C to 8°C
(refrigerated), existing vaccine supply chain channels can be used
for its distribution.
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 NovavaxNovavax,
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:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com
Solebury Trout
Jennifer Porcelli | 617-974-8659
jporcelli@soleburytrout.com
Media
Laura Keenan | 410-419-5755
Amy Speak | 617-420-2461
media@novavax.com
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