U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over
PR96991
GAITHERSBURG, Md., July 14, 2022 /PRNewswire=KYODO JBN/ --
--Novavax' vaccine is the first protein-based COVID-19 vaccine authorized
in the U.S.
--Immunizations with the Novavax COVID-19 Vaccine, Adjuvanted as a primary
series will begin upon product release and once a policy recommendation
from the CDC is received
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has
received emergency use authorization (EUA) from the U.S. Food and Drug
Administration (FDA) to provide a two-dose primary series for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years
of age and over.
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"Today's FDA emergency use authorization of our COVID-19 vaccine provides the
U.S. with access to the first protein-based COVID-19 vaccine," said Stanley C.
Erck, President and Chief Executive Officer, Novavax. "This authorization
reflects the strength of our COVID-19 vaccine's efficacy and safety data, and
it underscores the critical need to offer another vaccine option for the U.S.
population while the pandemic continues."
"Patients and providers in the U.S. now have access to a protein-based COVID-19
vaccine backed by data that have demonstrated efficacy, safety, and
tolerability," said Karen Kotloff, M.D., Professor of Pediatrics, University of
Maryland School of Medicine, Associate Director of Clinical Studies at the
Center for Vaccine Development and Global Health, COVID-19 Prevention Network
co-lead for the PREVENT-19 trial. "Offering more vaccine technologies and
options in our vaccination portfolio, including those built upon technologies
that have been successfully used for years, will hopefully help to increase our
country's vaccination rate."
The FDA EUA was based on data from the pivotal Phase 3 clinical trial,
PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and
over in the U.S. and Mexico. In the trial, the Novavax COVID-19 Vaccine,
Adjuvanted demonstrated 90.4% efficacy (95% confidence interval [CI], 83.8% to
94.3%; P<0.001) with a reassuring safety profile. Among participants 18 through
64 years of age, solicited adverse reactions (AR) following administration of
any dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site
pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%), headache
(52.9%), joint pain (25.4%), nausea/vomiting (15.6%), injection site redness
(7.0%), injection site swelling (6.3%), and fever (6.0%). In participants 65
years of age or over, solicited ARs following administration of any dose of the
Novavax COVID-19 Vaccine, Adjuvanted were injection site pain/tenderness
(63.4%), fatigue/malaise (39.2%), muscle pain (30.2%), headache (29.2%), joint
pain (15.4%), nausea/vomiting (7.3%), injection site swelling (5.3%), injection
site redness (4.8%), and fever (2.0%).
Doses of the Novavax COVID-19 Vaccine, Adjuvanted were shipped from the Serum
Institute of India Pvt. Ltd., the world's largest vaccine manufacturer by
volume, and are now in the U.S. The next step for the vaccine is a policy
recommendation for use from the Centers for Disease Control and Prevention
(CDC).
Earlier this week, the U.S. Department of Health and Human Services (HHS), in
collaboration with the Department of Defense, announced an agreement (
) to secure an initial 3.2 million doses of the Novavax' COVID-19 Vaccine,
Adjuvanted. These vaccine doses will be made available for free to states,
jurisdictions, federal pharmacy partners, and federally qualified health
centers.
In addition to the FDA EUA, the Novavax COVID-19 vaccine has received
conditional authorization for use in individuals aged 18 and over from multiple
regulatory agencies worldwide, including the European Commission (
) (EC), and emergency use listing from the World Health Organization (
) (WHO).
This project has been supported in part with federal funds from the Department
of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedicdal Advanced Research and Development
Authority (BARDA), through the Department of Defense Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)
under contract #MCDC2011-001.
Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by
the US Food and Drug Administration (FDA), but has been authorized for
emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a
two-dose primary series to individuals 18 years of age and older to prevent
Coronavirus Disease 2019 (COVID-19).
The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an
Emergency Use Authorization (EUA) to provide a two-dose primary series for
active immunization to prevent coronavirus disease 2019 (COVID-19) caused by
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18
years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with
a known history of a severe allergic reaction (e.g., anaphylaxis) to any
component of the Novavax COVID-19 Vaccine, Adjuvanted.
Warnings and Precautions
Management of Acute Allergic Reactions: Appropriate medical treatment to manage
immediate allergic reactions must be immediately available in the event an
acute anaphylactic reaction occurs following administration of the Novavax
COVID-19 Vaccine, Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted
recipients for the occurrence of immediate adverse reactions according to the
Centers for Disease Control (CDC) and Prevention guidelines (
https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html
).
Myocarditis and Pericarditis: Clinical trials data provide evidence for
increased risks of myocarditis and pericarditis following administration of the
Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information).
Syncope (fainting): May occur in association with administration of injectable
vaccines. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence: Immunocompromised persons, including individuals
receiving immunosuppressant therapy, may have a diminished immune response to
the Novavax COVID-19 Vaccine, Adjuvanted.
Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted
may not protect all vaccine recipients.
Adverse Reactions
Adverse reactions reported in clinical trials following administration of the
Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness,
fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection
site redness, injection site swelling, fever, chills, injection site pruritus,
hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and
pericarditis.
Myocarditis, pericarditis, and anaphylaxis have been reported following
administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical
trials.
Additional adverse reactions, some of which may be serious, may become apparent
with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider enrolled in the federal COVID-19 Vaccination Program
is responsible for mandatory reporting of the following to the Vaccine Adverse
Event Reporting System (VAERS):
-- vaccine administration errors whether or not associated with an adverse
event,
-- serious adverse events (irrespective of attribution to vaccination),
-- cases of Multisystem Inflammatory Syndrome (MIS), and
-- cases of COVID-19 that results in hospitalization or death.
Complete and submit reports to VAERS online:
https://vaers.hhs.gov/reportevent.html. For further assistance with reporting
to VAERS, call 1-800-822-7967. The reports should include the words "Novavax
COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.
To the extent feasible, report adverse events to Novavax, Inc. using the
following contact information or by providing a copy of the VAERS form to
Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809,
Telephone Number: 1-844-NOVAVAX (1-844-668-2829).
Please click to see the Novavax COVID-19 Vaccine, Adjuvanted Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccine Providers) and EUA Full
Prescribing Information ( https://www.fda.gov/media/159897/download ).
About NVX-CoV2373 (Novavax' COVID-19 Vaccine, Adjuvanted)
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. The
vaccine 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.
NVX-CoV2373 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.
The PREVENT-19 trial of NVX-CoV2373 is being conducted with support from the
U.S. government, including the Department of Defense, the Biomedical Advanced
Research and Development Authority (BARDA), part of the Office of the Assistant
Secretary for Preparedness and Response at the HHS, and the National Institute
of Allergy and Infectious Diseases, part of the National Institutes of Health
at HHS. BARDA is providing up to $1.75 billion under a Department of Defense
agreement (# MCDC2011-001). The Department of Defense Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense is also
providing funding of up to $45.7 million under a separate agreement. To date,
the U.S. government has agreed to order 3.2 million doses of NVX-CoV2373 under
these existing agreements should NVX-CoV2373 receive a recommendation from the
CDC. Novavax and the U.S. government will determine the timing, pricing, and
amounts for delivery of any additional NVX-CoV2373 doses. Novavax intends to
pursue additional U.S. procurement of both NVX-CoV2373 doses and other
potential formulations.
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, 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 Matrix-M(TM) 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.
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 authorization from multiple regulatory
authorities globally, including the U.S., EC and the WHO. The vaccine is
currently under review by multiple regulatory agencies worldwide, including for
additional indications and populations such as adolescents and as a booster. In
addition to its COVID-19 vaccine, Novavax is also currently evaluating a
COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical
trial, which combines NVX-CoV2373 and NanoFlu*, its quadrivalent influenza
investigational vaccine candidate, and is also evaluating an Omicron
strain-based vaccine (NVX-CoV2515) as well as a bivalent Omicron-based /
original strain-based vaccine. 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 connect with us on LinkedIn (
https://www.linkedin.com/company/novavax/ ).
*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle
influenza vaccine candidate produced by Novavax. This investigational candidate
was evaluated during a controlled phase 3 trial conducted during the 2019-2020
influenza season.
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 an Omicron strain based vaccine and
bivalent Omicron-based / original strain based vaccine, a COVID-seasonal
influenza investigational vaccine candidate, the scope, timing and outcome of
future regulatory filings and actions, including a potential policy
recommendation from the Centers for Disease Control and Prevention, 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 use in adults and adolescents, and as a
booster, the potential impact and reach of Novavax and NVX-CoV2373 in
addressing vaccine access, controlling the pandemic and protecting populations,
the efficacy, safety and intended utilization of NVX-CoV2373, and expected
administration 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; unanticipated challenges or delays
in conducting clinical trials; 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 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
Alex Delacroix | +1 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | +1 202-709-5563
media@novavax.com
SOURCE: Novavax, Inc.
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