Country for PR: United States
Contributor: PR Newswire New York
Friday, June 24 2022 - 06:06
Novavax COVID-19 Vaccine Nuvaxovid(TM) Recommended for Expanded Conditional Marketing Authorization in the European Union by CHMP for Adolescents Aged 12 Through 17
GAITHERSBURG, Md., June 24, 2022 /PRNewswire-AsiaNet/ --

--Upon authorization, Nuvaxovid(TM) would be the first protein-based option for 
adolescents aged 12 through 17 in Europe
--Nuvaxovid(TM) demonstrated 80% efficacy and was generally well-tolerated in 

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing 
and commercializing next-generation vaccines for serious infectious diseases, 
today announced that the Nuvaxovid(TM) (NVX-CoV2373) COVID-19 vaccine has been 
recommended for expanded conditional marketing authorization (CMA) in the 
European Union (EU) for adolescents aged 12 through 17. The Committee for 
Medicinal Products for Human Use (CHMP) of the European Medicines Agency based 
its opinion on results from the Phase 3 PREVENT-19 clinical trial.

Logo -

"This recommendation brings us closer to offering adolescents in the EU the 
first protein-based COVID-19 vaccine developed using an innovative approach to 
traditional technology," said Stanley C. Erck, President and Chief Executive 
Officer, Novavax.

The CHMP recommendation 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 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. Fever was 
seen more frequently in adolescents than in adults. These effects are usually 
mild or moderate and improve within a few days from the vaccination.

The European Commission (EC) granted CMA for Nuvaxovid to prevent COVID-19 in 
people 18 years of age and over in December 2021 ( 

In the 12 through 17 year-old population, emergency use authorization ( 
) has been granted in India.

Authorization in the U.S.

The Novavax COVID-19 vaccine (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 Administration.

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

    --  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:

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

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 
combination 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 uncertainties.

Alex Delacroix | +1 240-268-2022

Ali Chartan | +1 240-720-7804

SOURCE: Novavax, Inc.