Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India
PR93880
GAITHERSBURG, Md. and PUNE, India, Dec. 29, 2021 /PRNewswire=KYODO JBN/ --
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 Drugs Controller General of
India (DCGI) has granted emergency use authorization (EUA) for Novavax'
recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M(TM)
adjuvant. The vaccine will be manufactured and marketed in India by SII under
the brand name Covovax(TM).
"No one is safe until everyone is safe, and today's authorization marks a vital
step for India, where additional vaccine options and millions of doses are
needed in the country's ongoing efforts to control the pandemic," said Stanley
C. Erck, President and Chief Executive Officer, Novavax. "Novavax and SII will
not rest in our partnership to deliver our vaccine to those in India and across
the globe, as we work to protect the health of people everywhere."
Because the vaccine is stored with standard refrigeration at 2 degrees to 8
degrees Celsius, it may be transported and stored using existing vaccine supply
chain, potentially increasing access in hard-to-reach areas.
"The approval of Covovax in India marks a significant milestone in
strengthening our immunization efforts across India and LMICs," said Adar
Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to
deliver a protein-based COVID-19 vaccine, based on Phase 3 clinical data
demonstrating more than 90% efficacy and a favorable safety profile, to our
nation."
The Novavax/SII vaccine recently received EUA in Indonesia (
) and the Philippines (
), as well as Emergency Use Listing (EUL) with the World Health Organization (
) (WHO). Novavax was also granted Conditional Marketing Authorization by the
European Commission and EUL with the WHO for its vaccine, which will be
marketed by Novavax as Nuvaxovid(TM). Novavax has also announced regulatory
filings for its vaccine in multiple countries worldwide, while partners SK
bioscience and Takeda have submitted regulatory filings in South Korea (
) and Japan, respectively. Novavax expects to submit the complete package to
the U.S. FDA by the end of the year.
For additional information on Covovax, please visit the following websites in
the coming days:
-- Central Drugs Standard Control Organization (India) (
)
-- Serum Institute of India (
)
Authorized Use of Novavax' Covid-19 Vaccine in India
The Drugs Controller General of India (DCGI) has issued Emergency Use
Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus
5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18
years old and above.
Authorization in the U.S.
NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name
Nuvaxovid has not yet been approved by the U.S. FDA.
Important Safety Information
Covovax is contraindicated in persons who have hypersensitivity to the active
substance or to any of the excipients of this vaccine.
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(TM) 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 degrees – 8 degrees 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.
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. Full results of the trial were
published in the New England Journal of Medicine (
) (NEJM).
PREVENT-19, a trial in the U.S. and Mexico, with 25,452 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 NEJM (
).
About Matrix-M(TM) Adjuvant
Novavax' patented saponin-based Matrix-M(TM) 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 India, Indonesia and the Philippines, and has
been submitted for regulatory authorization in multiple markets globally.
NanoFlu(TM), 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(TM) 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, the ongoing development of NVX-CoV2373 and its partnerships, the
scope, timing and outcome of future regulatory filings and actions, the role
that COVOVAX may play in helping to increase vaccination rates and to control
the COVID-19 pandemic in India and across the globe, Novavax' and SII's
continued efforts to deliver COVOVAX to those in India and across the globe,
and COVOVAX's potential to increase vaccination access in hard-to-reach areas
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 | +1 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | +1 617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | +1 240-720-7804
Laura Keenan Lindsey | +1 202-709-7521
media@novavax.com
Serum Institute of India
Mayank Sen | +919867974055
mayank.sen@seruminstitute.com
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SOURCE Novavax, Inc.
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