- First EUL granted by WHO for a protein-based COVID-19
vaccine
- EUL vaccine manufactured and marketed by SII as
COVOVAX™
- WHO EUL for Nuvaxovid™ currently under assessment; will be
completed following European Medicines Agency (EMA) review
GAITHERSBURG, Md. and
PUNE, India, Dec. 17, 2021 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's
largest vaccine manufacturer by volume, today announced that the
World Health Organization (WHO) has granted Emergency Use Listing
(EUL) for NVX-CoV2373, Novavax' recombinant nanoparticle
protein-based COVID-19 vaccine with Matrix-M™ adjuvant, for active
immunization of individuals 18 years of age and older for the
prevention of coronavirus disease 2019 caused by SARS-CoV-2.
Today's EUL pertains to vaccine manufactured and marketed by SII as
COVOVAX™, a novel recombinant, adjuvanted SARS-CoV-2 rS Vaccine, in
India and licensed territories. An
additional EUL filing is under review by the WHO for vaccine to be
marketed by Novavax under the brand name Nuvaxovid™.
The EUL prequalifies Novavax' COVID-19 vaccine as meeting the
established WHO standards for quality, safety and efficacy. EUL is
a prerequisite for exports to numerous countries, including those
participating in the COVAX Facility, which was established to
allocate and distribute vaccines equitably to participating
countries and economies.
"Today's decision from the World Health Organization is vital to
ensuring global access to a protein-based COVID-19 vaccine for
hundreds of millions of people around the world," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "We thank the World Health Organization for its
thorough assessment. We believe this vaccine will help overcome
barriers to vaccine access in many regions of the world by
leveraging the traditional refrigeration used in existing vaccine
supply channels, while also offering an option based on a familiar
and well-understood technology."
"The EUL by the World Health Organization is a great
encouragement towards making COVID-19 vaccines more accessible. Our
partnership with Novavax has been successful in providing global
public health leadership and ensuring that all countries have broad
access to a viable vaccine," said Adar Poonawalla, Chief Executive
Officer, Serum Institute of India. "COVOVAX is the first
protein-based COVID-19 vaccine option, with demonstrated efficacy
and a well-tolerated safety profile, to be made available through
the COVAX Facility. We thank the WHO and seek to help the world
control the spread of the pandemic."
"It is very welcome news that the world now has a new weapon in
its arsenal of tools to fight COVID-19," said Dr Richard Hatchett, Chief Executive Officer,
Coalition for Epidemic Preparedness Innovations (CEPI). "CEPI's
investments to accelerate the clinical development and
manufacturing of Novavax' vaccine have been critical to enabling
equitable access to the vaccine through COVAX."
"We welcome the news that the COVOVAX vaccine has received WHO
Emergency Use Listing, providing the world – and COVAX participants
– with another promising class of vaccine as well as yet another
tool in the battle against COVID-19," said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.
"With data on safety and efficacy against several variants, strong
potential in mix and match and booster regimens, and standard
storage temperatures, this vaccine will provide countries with
another critical option in the quest to help protect their
populations."
The grant of EUL was based on the totality of preclinical,
manufacturing and clinical trial data submitted for review. This
includes two pivotal Phase 3 clinical trials: PREVENT-19, which
enrolled approximately 30,000 participants in the U.S. and
Mexico, the results of which were
published December 15, 2021 in the
New England Journal of Medicine (NEJM); and a trial that
evaluated the vaccine in more than 14,000 participants in the U.K.,
the results of which were published June 30,
2021 in NEJM. In both trials, NVX-CoV2373
demonstrated high efficacy and a reassuring safety and tolerability
profile. Novavax will continue to collect and analyze real-world
data, including the monitoring of safety and the evaluation of
variants, as the vaccine is distributed.
Novavax and SII recently received emergency use authorization
(EUA) for COVOVAX in Indonesia and the Philippines. The vaccine is also currently
under review by multiple regulatory agencies worldwide. The company
expects to submit its complete chemistry, manufacturing and
controls (CMC) data package to the U.S. FDA by the end of the
year.
For additional information on today's announcement and COVOVAX,
please visit the following websites:
- World Health Organization
- Serum Institute of India
Emergency Use Listing of COVOVAX™ by the
World Health Organization
The World Health Organization
(WHO) has issued Emergency Use Listing for COVOVAX/Recombinant
Spike Protein of SARS-CoV-2 Virus 5 mcg for active immunization of
individual 18 years of age and older for the prevention of
coronavirus disease 2019 caused by SARS-CoV-2.
About NVX-CoV2373
NVX-CoV2373 is a
protein-based vaccine engineered from the genetic sequence of the
first strain 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 formulated with Novavax' patented saponin-based
Matrix-M™ adjuvant 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.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid
formulation in a vial containing ten doses. The vaccination regimen
calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M
adjuvant) given intramuscularly 21 days apart. The vaccine is
stored at 2°- 8° Celsius, enabling the use of existing vaccine
supply and cold chain channels.
Novavax has established partnerships for the manufacture,
commercialization and distribution of NVX-CoV2373 worldwide.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is
being evaluated in two pivotal Phase 3 trials.
A trial conducted in the U.K. with 14,039 participants was
designed as a randomized, placebo-controlled, observer-blinded
study and achieved overall efficacy of 89.7%. The primary endpoint
was based on the first occurrence of PCR-confirmed symptomatic
(mild, moderate or severe) COVID-19 with onset at least 7 days
after the second study vaccination in serologically negative (to
SARS-CoV-2) adult participants at baseline.
PREVENT-19, a trial in the U.S. and Mexico, with 25,452 participants, achieved
90.4% efficacy overall. It was designed as a is a 2:1 randomized,
placebo-controlled, observer-blinded study to evaluate the
efficacy, safety and immunogenicity of NVX-CoV2373. The primary
endpoint for PREVENT-19 was the first occurrence of PCR-confirmed
symptomatic (mild, moderate or severe) COVID-19 with onset at least
7 days after the second dose in serologically negative (to
SARS-CoV-2) adult participants at baseline. The statistical success
criterion included a lower bound of 95% CI >30%. The key
secondary endpoint is the prevention of PCR-confirmed, symptomatic
moderate or severe COVID-19. Both endpoints were assessed at least
seven days after the second study vaccination in volunteers who had
not been previously infected with SARS-CoV-2. It was generally
well-tolerated and elicited a robust antibody response in both
studies.
About Matrix-M™ Adjuvant
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 harnesses the
power and speed of genetic engineering to efficiently produce
highly immunogenic nanoparticles designed to address urgent global
health needs. NVX-CoV2373, the company's COVID-19 vaccine, received
Emergency Use Authorization in Indonesia and the
Philippines and has been submitted for regulatory
authorization in multiple markets globally. NanoFlu™, the company's
quadrivalent influenza nanoparticle vaccine, met all primary
objectives in its pivotal Phase 3 clinical trial in older adults.
Novavax is currently evaluating a COVID-NanoFlu combination vaccine
in a Phase 1/2 clinical trial, which combines the company's
NVX-CoV2373 and NanoFlu vaccine candidates. These 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, LinkedIn, Instagram and Facebook.
About Serum Institute of India Pvt. Ltd.
Driven by
the philanthropic philosophy of affordable vaccines, Serum
Institute of India Pvt, Ltd. is the world's largest vaccine
manufacturer by number of doses produced and sold globally (more
than 1.5 billion doses), supplying the world's least expensive and
WHO-accredited vaccines to as many as 170 countries. It was founded
in 1966 with the aim of manufacturing lifesaving immunobiological
drugs including vaccines worldwide. With a strong commitment
towards global health, the institute's objective has been
proliferated by bringing down the prices of newer vaccines such as
such as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B,
Measles, Mumps and Rubella vaccines. SII is credited with bringing
world-class technology to India, through its state-of-the-art
equipped multifunctional production facility in Manjari, Pune;
association with Zipline and government agencies to transform
emergency medicine and critical care along with spearheading the
race of vaccine development against the COVID-19 pandemic.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
partnerships, the ongoing development of NVX-CoV2373, the scope,
timing and outcome of future regulatory filings and actions, the
belief that COVOVAX will help overcome barriers to vaccine access
in many regions of the world by leveraging the traditional
refrigeration used in existing vaccine supply channels, the role
that Novavax may play in helping to control the COVID-19 pandemic,
Novavax' plans to deliver a COVID-19 vaccine to hundreds of
millions of people around the world, the potential to mix and match
booster regimens, and Novavax' plans to submit a complete CMC data
package to the U.S. FDA by the end of the year are forward-looking
statements. Novavax cautions that these forward-looking statements
are subject to numerous risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. These risks and uncertainties include
challenges satisfying, alone or together with partners, various
safety, efficacy, and product characterization requirements,
including those related to process qualification and assay
validation, necessary to satisfy applicable regulatory authorities;
difficulty obtaining scarce raw materials and supplies; resource
constraints, including human capital and manufacturing capacity, on
the ability of Novavax to pursue planned regulatory pathways;
challenges meeting contractual requirements under agreements with
multiple commercial, governmental, and other entities; and those
other risk factors identified in the "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" sections of Novavax' Annual Report on Form
10-K for the year ended December 31,
2020 and subsequent Quarterly Reports on Form 10-Q, 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 www.sec.gov and
www.novavax.com, 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
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey |
202-709-7521
media@novavax.com
Logo -
https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg