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Contributor: PR Newswire New York
Wednesday, July 06 2022 - 00:28
Novavax Nuvaxovid(TM) COVID-19 Vaccine Conditionally Authorized in the European Union for Adolescents Aged 12 Through 17
GAITHERSBURG, Md., July 6, 2022 /PRNewswire-AsiaNet/ --

-- Nuvaxovid(TM) COVID-19 vaccine is the first protein-based option for 
adolescents aged 12 through 17 in Europe

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing 
and commercializing next-generation vaccines for serious infectious diseases, 
today announced that the European Commission (EC) has approved the expanded 
conditional marketing authorization (CMA) of Nuvaxovid(TM) (NVX-CoV2373) 
COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17. 
The approval follows the positive recommendation made by the European Medicines 
Agency's Committee for Medicinal Products for Human Use on June 23, 2022 ( 

"With this authorization, we are extremely pleased to be able to offer our 
Nuvaxovid COVID-19 vaccine to adolescents in the EU," said Stanley C. Erck, 
President and Chief Executive Officer, Novavax. "Our protein-based vaccine was 
developed using an innovative approach to traditional technology and has 
demonstrated efficacy and safety in both adolescents and adults."

The authorization was based on data from the ongoing pediatric expansion ( 
) of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 
17 years across 73 sites in the U.S., to evaluate the safety, effectiveness 
(immunogenicity), and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved 
its primary effectiveness endpoint and demonstrated 80% clinical efficacy 
overall at a time when the Delta variant was the predominant circulating 
SARS-CoV-2 strain in the U.S.

Preliminary safety data from the trial showed the vaccine to be generally 
well-tolerated. Serious and severe adverse events were low in number and 
balanced between vaccine and placebo groups, and not considered related to the 
vaccine. Local and systemic reactogenicity was generally lower than or similar 
to adults, after the first and second dose. The most common adverse reactions 
observed were injection site tenderness/pain, headache, myalgia, fatigue, and 
malaise. There was no increase in reactogenicity in younger (12 to <15 years 
old) adolescents compared to older (15 to <18 years old) adolescents. No new 
safety signal was observed through the placebo-controlled portion of the study.

The EC granted CMA for Nuvaxovid to prevent COVID-19 in individuals aged 18 and 
over in December 2021 ( 
). In addition to the EC's expanded CMA, India ( 
) has granted emergency use authorization in the 12 through 17 year-old 

Authorization in the U.S.

NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name 
Nuvaxovid(TM) has not yet been approved by the U.S. Food and Drug 

Important Safety Information

    -- Nuvaxovid 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 Nuvaxovid.
    -- Anxiety-related reactions, including vasovagal reactions (syncope), 
       hyperventilation, or stress&#8208;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.
    -- Nuvaxovid 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 Nuvaxovid may be lower in immunosuppressed individuals.
    -- Administration of Nuvaxovid in pregnancy should only be considered
       when the potential benefits outweigh any potential risks for the
       mother and foetus.
    -- The effects with Nuvaxovid may temporarily affect the ability to
       drive or use machines.
    -- Individuals may not be fully protected until seven days after their
       second dose. As with all vaccines, vaccination with Nuvaxovid 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.

For additional information on Nuvaxovid, please visit the following websites:

    -- European Medicines Agency ( 
    -- European Commission ( 
    -- Novavax global authorization website ( 

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. The 
vaccine 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. 

The 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, the world's 
largest vaccine manufacturer by volume. They will later be supplemented with 
data from additional manufacturing sites throughout Novavax' global supply 

About the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373 continues being evaluated in two pivotal Phase 3 trials. 

PREVENT-19 (the&#8239;PRE-fusion protein 
subunit&#8239;Vaccine&#8239;Efficacy&#8239;Novavax&#8239;Trial | COVID-19) is a 
2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the 
efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 
29,960 participants 18 years of age and over in 119 locations in&#8239;the 
U.S.&#8239;and&#8239;Mexico. The primary endpoint for PREVENT-19 was the first 
occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 
with onset at least seven 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. In the 
trial, NVX-CoV2373 achieved 90.4% efficacy overall. 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&#8239;New England 
Journal of Medicine&#8239;( 
 ) (NEJM). 

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, 
observer-blinded trial to evaluate the safety, effectiveness, and efficacy of 
NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 
years of age in 73 locations in the United States, compared with placebo. In 
the pediatric trial, NVX-CoV2373 achieved its primary effectiveness endpoint 
(non-inferiority of the neutralizing antibody response compared to young adult 
participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% 
efficacy overall at a time when the Delta variant of concern was the 
predominant circulating strain in the U.S.&#8239;Additionally, immune responses 
were about two-to-three-fold higher in adolescents than in adults against all 
variants studied. 

PREVENT-19 is being conducted with support from the U.S. government, including 
the Department of Defense, the Biomedical Advanced Research and Development 
Authority (BARDA), part of the Office of the Assistant Secretary for 
Preparedness and Response at the U.S. Department of Health and Human Services 
(HHS), and the National Institute of Allergy and Infectious Diseases, part of 
the National Institutes of Health at HHS. BARDA is providing up to&#8239;$1.75 
billion&#8239;under a Department of Defense agreement (# MCDC2011-001). 

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 
years and over 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 seven 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 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 currently under review by multiple 
regulatory agencies worldwide and will soon be under review in the U.S. for use 
in adults, adolescents and as a booster. In addition to its COVID-19 vaccine, 
Novavax is also currently evaluating a COVID-seasonal influenza combination 
vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and 
NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is 
also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a 
bivalent Omicron-based / original strain-based vaccine. These vaccine 
candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to 
enhance the immune response and stimulate high levels of neutralizing 

For more information, visit&#8239; ;and connect with us on 
LinkedIn ( ). 

*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle 
influenza vaccine candidate produced by Novavax. This investigational candidate 
was evaluated during a controlled phase 3 trial conducted during the 2019-2020 
influenza season.&#8239;

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, a 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 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 and, 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 

Alex Delacroix | +1 240-268-2022 

Ali Chartan | +1 240-720-7804

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SOURCE  Novavax, Inc.