European Commission Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine
PR93801
GAITHERSBURG, Md., Dec. 21, 2021 /PRNewswire=KYODO JBN/ --
-- Nuvaxovid(TM) COVID-19 Vaccine (recombinant, adjuvanted) is the first
protein-based COVID-19 vaccine authorized for use in Europe
-- Novavax and the European Commission previously announced an advance
purchase agreement for up to 200 million doses through 2023
-- Authorization follows positive recommendation by European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP)
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 granted (
) Novavax conditional marketing authorization (CMA) 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. The
authorization follows the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) recommendation (
) today to authorize the vaccine (also known as NVX-CoV2373) and is applicable
in all 27 European Union (E.U.) member states.
"We welcome today's European Commission decision reflecting the first
authorization of a protein-based COVID-19 vaccine for the people of the E.U.,"
said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank
the European Medicines Agency, the Committee for Medicinal Products for Human
Use reviewers and the European Commission for their thorough assessment as we
look forward to playing a critical role in helping to address the continued
threat of COVID-19. We also thank the thousands of clinical trial participants,
our partners and Novavax employees worldwide who have contributed to this
historic milestone."
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) to view multimedia content that accompanies this press release.
The EMA opinion and related EC decision is based on the totality of
preclinical, manufacturing and clinical trial data submitted for review. This
includes two pivotal Phase 3 clinical trials: PREVENT-19 which included 30,000
participants in the U.S. and Mexico, the results of which were published in The
New England Journal of Medicine (NEJM) (
); and a trial with 15,000 participants in the U.K., the results of which were
also published in NEJM (
). In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable
safety and tolerability profile. Novavax will continue to collect and analyze
real-world data, including the monitoring of safety and the evaluation of
variants, as the vaccine is distributed.
Novavax and the EC announced (
) an advance purchase agreement (APA) for up to 200 million doses of Novavax'
COVID-19 vaccine in August 2021. Initial doses are expected to arrive in Europe
in January. Novavax is working with EMA and its partners to expedite local
release testing.
This authorization leverages Novavax' manufacturing partnership with Serum
Institute of India (SII), the world's largest vaccine manufacturer by volume,
which will supply initial doses for the E.U. It will later be supplemented with
data from additional manufacturing sites in Novavax' global supply chain.
Novavax and SII recently received emergency use authorization (EUA) in
Indonesia (
) and the Philippines (
), where it will be commercialized by SII under the trade name Covovax(TM).
The companies also received emergency use listing for Covovax from the World
Health Organization (
). The vaccine is also currently under review by multiple regulatory agencies
worldwide, and the company expects to submit its complete chemistry,
manufacturing and controls (CMC) data package to the U.S. Food and Drug
Administration (FDA) by the end of the year.
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.
Important Safety Information
-- Nuvaxovid(TM) 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
-- Anxiety-related reactions, including vasovagal reactions (syncope),
hyperventilation, or stress–related reactions may occur in association
with vaccination as a 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
-- Give Nuvaxovid 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
-- The duration of protection afforded by the vaccine is unknown as it is
still being determined by ongoing clinical trials
-- 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
(frequency category of very common greater than or equal to 1/10), were
headache, nausea or vomiting, myalgia, arthralgia, injection site
tenderness/pain, fatigue and malaise
Please visit https://www.novavaxcovidvaccine.com for the full leaflet and
adverse reaction reporting instructions.
Detailed information on this medicine is also available on the European
Medicines Agency web site: http://www.ema.europa.eu
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.
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.
Novavax has established partnerships for the manufacture, commercialization and
distribution of NVX-CoV2373 worldwide.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
A trial conducted in the U.K. with 14,039 participants 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.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000
participants, 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%. The key
secondary endpoint is 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 in both studies.
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, received Emergency Use Authorization in Indonesia and the
Philippines and has been submitted for regulatory authorization in multiple
markets globally. NanoFlu(TM), the company's quadrivalent influenza
nanoparticle vaccine, met all primary objectives in its pivotal Phase 3
clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu
combination vaccine in a Phase 1/2 clinical trial. 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 ongoing development of NVX-CoV2373, the scope,
timing and outcome of future regulatory filings and actions, including Novavax'
plans to supplement the CMA submitted to the EMA and, by the end of the year,
to submit a complete CMC data package to the U.S. FDA, the timing of the
arrival of doses, and Novavax' role in helping to address COVID-19 and control
the pandemic globally 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
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, 2020 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
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
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SOURCE Novavax, Inc.
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