Full Press Release Details
European Commission Grants Conditional Marketing
Authorization for Novavax COVID-19 Vaccine
- Dec. 20, 2021 - 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 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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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 . 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
in the European Union
European Commission has granted conditional marketing
authorization for Nuvaxovid 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
Please visit the www.NovavaxCovidVaccine.com
for the full leaflet and adverse reaction reporting instructions; this site will be live later this week.
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.
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 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
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 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.
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 , 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
adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and
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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