Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax' COVID-19 Vaccine in Adolescents
PR95125
Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax' COVID-19 Vaccine in Adolescents (greater than, or equal to)12 to <18 in India
GAITHERSBURG, Md. and PUNE, India, March 23, 2022 /PRNewswire=KYODO JBN/ --
-- First authorization of Novavax' COVID-19 vaccine in adolescent population
received
-- Covovax(TM) (SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein
Nanoparticle Vaccine) is the first protein-based COVID-19 vaccine authorized
for adolescents (greater than, or equal to)12 to <18 in India
-- Authorization highlights immunogenicity and reassuring safety profile of
Covovax in Phase 2/3 study of Indian adolescents aged (greater than, or equal
to) 12 to <18 and data from an ongoing Phase 3 pediatric expansion trial of
NVX-CoV2373 in adolescents aged (greater than, or equal to)12 to <18 in the U.S.
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 (greater than, or equal to)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(TM) 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 (greater than, or equal to)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
(greater than, or equal to)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 (greater than, or equal to)12 to
<18, results (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=118859063&u=https%3A%2F%2Fir.novavax.com%2F2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical-Trial&a=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
(greater than, or equal to)7 to <12 and (greater than, or equal to)2 to <7 years in India are
underway.
DCGI initially granted EUA for Covovax for adults 18 years old and above in
December (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=1374865207&u=https%3A%2F%2Fir.novavax.com%2F2021-12-28-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-India&a=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 (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=1922873189&u=https%3A%2F%2Fwww.seruminstitute.com%2FCOVOVAX.php&a=Serum+Institute+of+India)
-- Central Drugs Standard Control Organization (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=4206181535&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D2212331164%26u%3Dhttps%253A%252F%252Fcdsco.gov.in%252Fopencms%252Fopencms%252Fen%252FHome%252F%26a%3DCentral%2BDrugs%2BStandard%2BControl%2BOrganization%2B(India)&a=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(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(Deg.)- 8(Deg.) 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(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, 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(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
(https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=3124045176&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D2040794221%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3260461-1%2526h%253D1316526774%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3158017-1%252526h%25253D500821283%252526u%25253Dhttps%2525253A%2525252F%2525252Ftwitter.com%2525252FNovavax%252526a%25253DTwitter%2526a%253DTwitter%26a%3DTwitter&a=Twitter), LinkedIn (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=1948372359&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D27315898%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3260461-1%2526h%253D1508558197%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3158017-1%252526h%25253D3702938248%252526u%25253Dhttps%2525253A%2525252F%2525252Fwww.linkedin.com%2525252Fcompany%2525252Fnovavax%2525252F%252526a%25253DLinkedIn%2526a%253DLinkedIn%26a%3DLinkedIn&a=LinkedIn), Instagram (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=613462772&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D2634683834%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3367039-1%2526h%253D3348182013%2526u%253Dhttps%25253A%25252F%25252Fwww.instagram.com%25252Fnovavax%25252F%2526a%253DInstagram%26a%3DInstagram&a=Instagram) and Facebook (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=843636805&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D1555903536%26u%3Dhttps%253A%252F%252Fwww.facebook.com%252FNovavax%252F%26a%3DFacebook&a=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 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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SOURCE: Novavax, Inc.
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