- First authorization of Novavax' COVID-19 vaccine in
adolescent population received
- Covovax™ (SARS-CoV-2 rS Protein (COVID-19) recombinant spike
protein Nanoparticle Vaccine) is the first protein-based COVID-19
vaccine authorized for adolescents ≥12 to <18 in
India
- Authorization highlights immunogenicity and reassuring
safety profile of Covovax in Phase 2/3 study of Indian adolescents
aged ≥12 to <18 and data from an ongoing Phase 3 pediatric
expansion trial of NVX-CoV2373 in adolescents aged ≥12 to <18 in
the U.S.
GAITHERSBURG, Md. and PUNE, India, March 22, 2022 /CNW/ -- 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, announced that the
Drugs Controller General of India
(DCGI) has granted emergency use authorization (EUA) for Novavax'
protein-based COVID-19 vaccine for adolescents aged ≥12 to <18
years in India. The vaccine, also
known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name
Covovax™ and is the first protein-based vaccine authorized for use
in this age group in India.
"We're proud of this first approval in adolescents given the
efficacy and safety that our data show in this population, and that
our COVID-19 vaccine will provide an alternative protein-based
vaccine option for individuals 12 years of age and older in
India," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "We hope that this authorization of our COVID-19
vaccine in adolescents is the first of many worldwide so that
families have an additional choice built on a well-understood
platform used in other vaccines for decades."
A Phase 2/3, observer-blinded, randomized, controlled study in a
total of 460 Indian adolescents aged ≥12 to <18 years was
conducted to evaluate the safety and immunogenicity of Covovax. The
study demonstrated that Covovax was well-tolerated with a
reassuring safety profile. Furthermore, the data indicated that
Covovax is immunogenic in adolescents aged ≥12 to
<18 years. The authorization in India also references the ongoing PREVENT-19
pivotal Phase 3 pediatric expansion trial of NVX-CoV2373 in
adolescents in the U.S. aged ≥12 to <18, results of which were
shared in February.
"The approval of Covovax for adolescents 12 and older
in India marks another 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 with a favorable safety profile to the adolescents
of our nation."
Covovax is the fourth vaccine to receive EUA from the DCGI for
use among adolescents 12 and older. The safety and efficacy of
Covovax in adolescents aged less than 12 years have not yet been
established; however, studies evaluating the safety and
immunogenicity of Covovax for the age groups of ≥7 to <12 and ≥2
to <7 years in India are
underway.
DCGI initially granted EUA for Covovax for adults 18 years old
and above in December. In addition, Covovax has received Emergency
Use Listing (EUL) from the World Health Organization, as well as
EUA in Indonesia, the Philippines, and Bangladesh. For additional information on
Covovax, please visit the following websites:
- Serum Institute of India
- Central Drugs Standard Control Organization
Authorized Use of Novavax' COVID-19 Vaccine in India
The Drugs Controller General of
India (DCGI) has issued a
permission for restricted use in emergency situation for Covovax
for active immunization to prevent COVID-19 caused by SARS-CoV-2 in
individuals 12 years of age and older.
Authorization in the U.S.
NVX-CoV2373 has not yet been
authorized for use in the U.S. by the U.S. FDA.
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. Close observation for at least
15 minutes is recommended and 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. The presence of
a minor infection and/or low-grade fever should not delay
vaccination.
- NVX-CoV2373 should be given with caution in individuals
receiving anticoagulant therapy or those with thrombocytopenia or
any coagulation disorder (such as haemophilia) 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 foetus.
- 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 were headache, nausea or vomiting, myalgia, arthralgia,
injection site tenderness/pain, fatigue, and malaise.
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. Use of the vaccine should be in
accordance with official recommendations.
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 aged 18 years and older,
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%. A secondary
endpoint was 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 after the
second dose 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 aged 18
years and older 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, has
received conditional authorization from multiple regulatory
authorities globally, including the European Commission and the
World Health Organization. The vaccine is also under review by
multiple regulatory agencies worldwide. In addition to its COVID-19
vaccine, Novavax is also currently evaluating a COVID-seasonal
influenza combination vaccine in a Phase 1/2 clinical trial, which
combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza
investigational vaccine candidate. 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 timing of clinical trial results, the ongoing
development of NVX-CoV2373 and NanoFlu, its COVID-seasonal
influenza investigational vaccine candidate, the scope, timing and
outcome of future regulatory filings and actions, including
Novavax' plans to supplement existing authorizations with data from
the additional manufacturing sites in Novavax' global supply chain,
additional worldwide authorizations of NVX-CoV2373 for adolescents,
the potential impact and reach of Novavax and NVX-CoV2373 in
addressing vaccine access, controlling the pandemic and protecting
populations, and the efficacy, safety and intended utilization 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, without limitation, 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, 2021, 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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