Novavax COVID-19 Vaccine Nuvaxovid(TM) Recommended for Expanded Conditional Marketing Authorization in EU by CHMP for Adolescents Aged 12 Through 17

Novavax, Inc.

2022/6/24 15:33

PR96690

 

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=KYODO JBN/ --

 

--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

adolescents

 

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 - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg

 

"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

(

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=1846031258&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=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 (

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=4077074162&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3490095-1%26h%3D3782079808%26u%3Dhttps%253A%252F%252Fir.novavax.com%252F2021-12-20-European-Commission-Grants-Conditional-Marketing-Authorization-for-Novavax-COVID-19-Vaccine%26a%3DDecember&a=December+2021

).

 

In the 12 through 17 year-old population, emergency use authorization (

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=1557514344&u=https%3A%2F%2Fir.novavax.com%2F2022-03-22-Novavax-and-Serum-Institute-of-India-Announce-First-Emergency-Use-Authorization-of-Novavax-COVID-19-Vaccine-in-Adolescents-12-to-18-in-India&a=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-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:

 

    --  Novavax global authorization website (

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=3664322855&u=https%3A%2F%2Fwww.novavaxcovidvaccine.com%2F&a=global+authorization+website

)

    --  European Medicines Agency (

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=3113743083&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3490095-1%26h%3D1545350530%26u%3Dhttps%253A%252F%252Fwww.ema.europa.eu%252Fen%252Fmedicines%252Fhuman%252FEPAR%252Fnuvaxovid%26a%3DEuropean%2BMedicines%2BAgency&a=European+Medicines+Agency

)

    --  European Commission (

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=628121259&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3490095-1%26h%3D2784477625%26u%3Dhttps%253A%252F%252Fec.europa.eu%252Fcommission%252Fpresscorner%252Fdetail%252Fen%252Fip_21_6966%26a%3DEuropean%2BCommission&a=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

chain.

About the NVX-CoV2373 Phase 3 Trials

 

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

 

PREVENT-19 (the PRE-fusion protein

subunit Vaccine Efficacy Novavax 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 the

U.S. and& 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 New England

Journal of Medicine (

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=3105155329&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3440781-1%26h%3D467849857%26u%3Dhttps%253A%252F%252Fwww.nejm.org%252Fdoi%252Ffull%252F10.1056%252FNEJMoa2116185%253Fquery%253Dfeatured_home%26a%3DNew%2BEngland%2BJournal%2Bof%2BMedicine&a=New+England+Journal+of+Medicine

) (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. 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 $1.75

billion 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 (

https://c212.net/c/link/?t=0&l=en&o=3576637-1&h=1520321630&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3440781-1%26h%3D3617137863%26u%3Dhttps%253A%252F%252Fwww.nejm.org%252Fdoi%252Ffull%252F10.1056%252FNEJMoa2107659%26a%3DNEJM&a=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

antibodies.

 

For more information, visit www.novavax.com ;and connect with us on

LinkedIn ( https://www.linkedin.com/company/novavax/ ).

 

*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.

 

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 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

Alex Delacroix | +1 240-268-2022

ir@novavax.com

 

Media

Ali Chartan | +1 240-720-7804

media@novavax.com

 

SOURCE: Novavax, Inc.  

 

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