Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization
PR93133
GAITHERSBURG, Md., Nov. 18, 2021 /PRNewswire=KYODO JBN/ --
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that European Medicines Agency (EMA) has begun its evaluation
of an application for conditional marketing authorization (CMA) for Novavax'
COVID-19 vaccine, which will be marketed in the European Union under the brand
name Nuvaxovid(TM). EMA's statement may be found here [
].
"Today's announcement from EMA brings Novavax another step closer to our goal of
ensuring broad global access to our protein-based COVID-19 vaccine across
Europe," said Stanley C. Erck, President and Chief Executive Officer, Novavax.
"Novavax looks forward to providing an additional vaccine option in Europe,
built on a proven, well-understood technology platform, and thanks the European
Commission for its ongoing partnership and confidence in our COVID-19 program."
The company announced [
] earlier this month that it had completed the submission of all data and
modules required by EMA for regulatory evaluation of NVX-CoV2373, Novavax'
recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M(TM)
adjuvant. EMA has indicated [
] that its assessment will proceed under an accelerated timeline, with an
opinion issued potentially within weeks.
The chemistry, manufacturing and controls (CMC) data package submitted to EMA
and other global regulatory agencies leverages Novavax' manufacturing
partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's
largest vaccine manufacturer by volume. It will later be supplemented with data
from additional manufacturing sites in Novavax' global supply chain.
The Novavax/SII vaccine has recently received Emergency Use Authorization (EUA)
in Indonesia [
] and the Philippines [
], and the companies have also filed for emergency authorization in India and
for Emergency Use Listing (EUL) with the World Health Organization [
] (WHO). Novavax also announced regulatory filings for its vaccine in the
United Kingdom [
], Australia [
], New Zealand [
], Canada [
] and with the WHO [
]. Additionally, Novavax and SK bioscience announced a Biologics License
Application (BLA) submission to MFDS in South Korea [
]. Novavax expects to submit the complete package to the U.S. FDA by the end of
the year.
The brand name Nuvaxovid(TM) has not been authorized by the U.S. FDA.
About the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the
U.K. that demonstrated efficacy of 96.4% against the original virus strain,
86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the
PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection
against moderate and severe disease and 90.4% efficacy overall. It was generally
well-tolerated and elicited a robust antibody response.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate 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
microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21
days apart. The vaccine is stored at 2 degrees- 8 degrees Celsius, enabling the
use of existing vaccine supply and cold chain channels.
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 combines the power and speed of
genetic engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. Novavax is conducting late-stage
clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the
virus that causes COVID-19. NanoFlu(TM), its quadrivalent influenza nanoparticle
vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in
older adults. Both 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 on Twitter [
] and LinkedIn [
].
Forward-Looking Statements
Statements herein relating to the future of Novavax, including Novavax' plans to
supplement its CMC data package submitted to EMA with data from additional
manufacturing sites in Novavax' global supply chain, 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; resource constraints, including human
capital and manufacturing capacity, on the ability of Novavax to pursue planned
regulatory pathways; 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 statement. 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 statement 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
Alison Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
media@novavax.com
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SOURCE Novavax, Inc.
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