Novavax Submits Request to Expand Conditional Marketing Authorization of COVID-19 Vaccine in the European Union to Adolescents (Ages 12-17)
PR95269
GAITHERSBURG, Md., March 31, 2022 /PRNewswire=KYODO JBN/ --
- If granted, Nuvaxovid (TM) COVID-19 Vaccine (recombinant, adjuvanted)
would be the first protein-based option for adolescents aged 12-17
years in Europe
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced submission of its request to expand the conditional marketing
authorization (CMA) of Nuvaxovid (TM) COVID-19 Vaccine (recombinant,
adjuvanted) in the European Union (EU) to adolescents aged 12 through 17 years.
Logo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg
"We are continuing to see spikes in COVID-19 across Europe and recognize the
need to improve vaccination rates, particularly in the pediatric population,"
said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We look
forward to a decision from the European Medicines Agency and firmly believe in
the benefit of diversified vaccine options."
The submission includes clinical 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 Novavax' COVID-19 vaccine. The vaccine, also
known as NVX-CoV2373, achieved its primary effectiveness endpoint in the trial
and demonstrated 80% efficacy overall at a time when the Delta variant was the
predominant circulating strain in the U.S.
Additionally, preliminary safety data from the pediatric expansion of
PREVENT-19 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.
The submission builds on Novavax' efforts to expand authorizations of its
COVID-19 vaccine to younger populations. The Drugs Controller General of India
recently approved NVX-CoV2373 for restricted use in emergency situation for
adolescents aged 12 through 17 years in India (
). SK bioscience, Novavax' licensee in South Korea, also recently submitted (
) a regulatory filing for adolescent authorization of the vaccine to the Korean
Ministry of Food and Drug Safety. Novavax expects to initiate rolling
submissions of regulatory filings in this age group to additional regulatory
authorities worldwide and to initiate additional studies globally evaluating
younger age groups during the second quarter of 2022.
The European Commission granted CMA for Nuvaxovid to prevent COVID-19 in people
18 years of age and older in December (
) 2021. Doses of Nuvaxovid began shipping to EU member states shortly
thereafter. For additional information on Nuvaxovid, please visit the following
websites:
- European Medicines Agency (
)
- European Commission (
)
Authorized Use of Nuvaxovid (TM) in the European Union
European Commission has granted conditional marketing authorization for
Nuvaxovid (TM) COVID-19 Vaccine (recombinant, adjuvanted) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years
of age and older.
Authorization in the U.S.
NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name
Nuvaxovid has not yet been approved by the U.S. FDA.
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 a
dministration 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 7 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 safety information, including the full Summary of Product
Characteristics with Package Leaflet, please visit www.NovavaxCovidVaccine.com.
Information on this medicine is also available on the European Medicines Agency
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.
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°- 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 (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 (
), LinkedIn (
), Instagram (
) and Facebook (
).
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, including Novavax' plans to initiate pediatric
studies in Q2 2022, 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
SOURCE Novavax, Inc.
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