GAITHERSBURG, Md. and PUNE,
India, Jan. 10, 2022
/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 a regulatory submission to
the South African Health Products Regulatory Agency (SAHPRA) for
emergency use authorization (EUA) of Novavax' recombinant
nanoparticle protein-based COVID-19 vaccine candidate with
Matrix-M™ adjuvant. If authorized, the vaccine (known as
NVX-CoV2373) will be manufactured by and commercialized by SII in
South Africa under the brand name
Covovax™.
"Novavax' is thankful for our long-standing history of
partnership in South Africa to
advance much-needed vaccines. This is exemplified by the country's
vital role in the Phase 2b clinical
trial and booster study of our protein-based COVID-19 vaccine,"
said Stanley C. Erck, President and
Chief Executive Officer, Novavax. "Novavax and Serum Institute
remain focused on delivering the COVID-19 vaccine - built on
well-understood technology - where it is needed most. We look
forward to SAHPRA's review and, if authorized, delivering the
vaccine to help South Africa
control the pandemic."
The submission for the regulatory evaluation by SAHPRA of
NVX-CoV2373 includes data from two pivotal Phase 3
clinical trials: PREVENT-19, which enrolled approximately 30,000
participants in the U.S. and Mexico and was published in the New England
Journal of Medicine (NEJM); and a trial with almost 15,000
participants in the U.K. which was also published in NEJM.
In both trials, the vaccine demonstrated high efficacy with a
reassuring safety profile. Serious and severe adverse events were
low in number and balanced between vaccine and placebo groups. The
most common adverse reactions observed during clinical studies
(frequency category of very common ≥1/10) were headache, nausea or
vomiting, myalgia, arthralgia, injection site tenderness/pain,
fatigue, and malaise. 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.
In total, Novavax' vaccine has received authorizations of the
vaccine in over 170 countries, including conditional marketing
authorization for its vaccine in the European Union and emergency
use listing (EUL) from the World Health Organization (WHO). The
Novavax/SII vaccine (Covovax) recently received EUA
in India, Indonesia and the Philippines, as well as WHO EUL is also
currently under review by multiple regulatory agencies worldwide.
This includes the submission of its complete chemistry,
manufacturing and controls (CMC) data package to the U.S. Food and
Drug Administration (FDA) at the end of 2021. The company expects
to submit a request for EUA for the vaccine in the U.S. after one
month in accordance with guidance from the FDA regarding
submission of all EUA vaccines.
For more information on NVX-CoV2373, including a full listing of
where it has been authorized for use, please visit Novavax' global
authorization website,
Important Safety Information
- NVX-CoV2373 is contraindicated in persons who have a
hypersensitivity to the active substance, or to any of the
excipients.
- Events of anaphylaxis have been reported with administration of
COVID-19 vaccines. Appropriate medical treatment and supervision
should be available in case of an anaphylactic reaction following
the administration of the vaccine. A second dose of the vaccine
should not be given to those who have experienced anaphylaxis to
the first dose of NVX-CoV2373.
- Anxiety-related reactions, including vasovagal reactions
(syncope), hyperventilation, or stress–related reactions may occur
in association with vaccination as a psychogenic response to the
needle injection. It is important that precautions are in place to
avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from
an acute severe febrile illness or acute infection.
- NVX-CoV2373 should be given with caution in individuals
receiving anticoagulant therapy or those with thrombocytopenia or
any coagulation disorder (such as hemophilia) because bleeding or
bruising may occur following an intramuscular administration in
these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed
individuals.
- Administration of NVX-CoV2373 in pregnancy should only be
considered when the potential benefits outweigh any potential risks
for the mother and fetus.
- The effects with NVX-CoV2373 may temporarily affect the ability
to drive or use machines.
- Individuals may not be fully protected until 7 days after their
second dose. As with all vaccines, vaccination with NVX-CoV2373 may
not protect all vaccine recipients.
- The most common adverse reactions observed during clinical
studies (frequency category of very common ≥1/10) were headache,
nausea or vomiting, myalgia, arthralgia, injection site
tenderness/pain, fatigue, and malaise.
For additional information, please visit
www.NovavaxCovidVaccine.com for the full Summary of Product
Characteristics with Package Leaflet, Prescribing Information and
Important Safety Information, adverse event reporting instructions,
or to request additional information.
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. The current assigned shelf life of
the vaccine is 9 months.
Novavax has established partnerships for the manufacture,
commercialization and distribution of NVX-CoV2373 worldwide.
Existing authorizations leverage Novavax' manufacturing partnership
with Serum Institute of India
(SII), the world's largest vaccine manufacturer by volume. They
will later be supplemented with data from additional manufacturing
sites throughout Novavax' global supply chain.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is
being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000
participants, achieved 90.4% efficacy overall. It was designed as 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. Full results of the trial were
published in the New England Journal of Medicine
(NEJM).
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. Full results of the
trial were published in NEJM.
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
Conditional Marketing Authorization from the European Commission,
Emergency Use Listing from the World Health Organization, 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 facilities at
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,
including Novavax' plans to submit an EUA application to the U.S.
FDA after one month, the potential impact of Novavax and
NVX-CoV2373 in addressing vaccine access, controlling the pandemic
and protecting populations, the efficacy, safety and intended
utilization of NVX-CoV2373, and the expected delivery of
NVX-CoV2373 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
Serum Institute of India
Mayank Sen | +91-986-797-4055
mayank.sen@seruminstitute.com
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SOURCE Novavax, Inc.