Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine
PR93795
GAITHERSBURG, Md., Dec. 21, 2021 /PRNewswire=KYODO JBN/ --
-- European Commission decision on conditional marketing authorization
expected imminently
-- Upon authorization, Nuvaxovid(TM) (also known as NVX-CoV2373) will be
the first protein-based COVID-19 vaccine available in Europe
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that the European Medicines Agency (EMA) has recommended
[
] granting a conditional marketing authorization for Novavax' COVID-19 vaccine
(also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age
and older. Upon authorization, NVX-CoV2373 will be marketed in the European
Union (E.U.) as Nuvaxovid(TM) COVID-19 Vaccine (recombinant, adjuvanted).
"Novavax appreciates the CHMP's positive opinion concerning our vaccine, and we
look forward to a decision from the European Commission," said Stanley C. Erck,
President and Chief Executive Officer, Novavax. "An authorization from the
Commission would deliver the first protein-based vaccine to the E.U. during a
critical time when we believe having choice among vaccines will lead to
increased immunization."
The EMA recommendation follows a positive CHMP opinion based on an expedited
review of the totality of manufacturing, preclinical, and clinical trial data
submitted by the company, with the conclusion that the vaccine meets the
stringent criteria set by the E.U. for efficacy, safety and quality. This
included data from two pivotal Phase 3 clinical trials: PREVENT-19, which
enrolled almost 30,000 participants in the U.S. and Mexico, and achieved an
overall efficacy of 90.4%, the results of which were published in the New
England Journal of Medicine [
] (NEJM)); and a trial with more than 14,000 participants in the U.K. that
achieved an overall efficacy of 89.7%, the results of which were also published
in NEJM [
]. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring
safety and tolerability profile.
Novavax and the European Commission announced [
] an advance purchase agreement (APA) for up to 200 million doses of Novavax'
COVID-19 vaccine in August 2021. This filing 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.
The brand name Nuvaxovid(TM) has not yet been authorized for use in the U.S. by
the FDA.
Authorization in the U.S.
NVX-CoV2373 has not 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 degrees - 8 degrees 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
potential for conditional marketing authorization of NVX-CoV2373 to increase
immunization and the scope, timing and outcome of future regulatory filings and
actions, including Novavax' plans to supplement the conditional marketing
authorization submitted to the EMA and, by the end of the year, to submit a
complete CMC data package to the U.S. FDA 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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