U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults
PR98379
GAITHERSBURG, Md., Oct. 20, 2022 /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 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 first booster dose at least six months after
completion of primary vaccination with an authorized or approved COVID-19
vaccine to individuals 18 years of age and older for whom an FDA-authorized
mRNA bivalent COVID-19 booster vaccine is not accessible or clinically
appropriate, and to individuals 18 years of age and older who elect to receive
the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not
receive a booster dose of a COVID-19 vaccine.
"The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first
protein-based option, as a booster," said Stanley C. Erck, President and Chief
Executive Officer, Novavax. "According to CDC data, almost 50 percent of adults
who received their primary series have yet to receive their first booster dose.
Offering another vaccine choice may help increase COVID-19 booster vaccination
rates for these adults."
The FDA EUA decision was based on data from the Phase 3 Prevent-19 clinical
trial and from the U.K.-sponsored COV-BOOST trial. In the Phase 3 trial, a
single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was
administered to healthy adult participants aged 18 and older approximately
eight or 11 months after their primary series. Following a booster dose,
antibody levels increased significantly relative to pre-boost levels, rising
above levels associated with protection in the Phase 3 trials. Neutralizing
antibodies also increased by 34- to 27-fold compared to pre-boost levels when
boosted at eight or 11 months. In the COV-BOOST trial, the Novavax COVID-19
Vaccine, Adjuvanted increased antibody titers when used as a third dose
following initial dosing with another authorized COVID-19 vaccine (heterologous
boosting).
In the trial, following the booster, local and systemic reactions had a median
duration of approximately two days. The incidence of Grade 3 or higher events
remained relatively low. Safety reporting of reactogenicity events showed an
increasing incidence across all three doses of the Novavax COVID-19 Vaccine,
Adjuvanted, often seen with increased immunogenicity. Among participants 18
years of age and older, solicited adverse reactions following administration of
a booster dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site
pain/tenderness (81.1%), fatigue/malaise (63.4%), muscle pain (63.0%), headache
(52.9%), joint pain (30.3%), nausea/vomiting (14.7%), injection site swelling
(8.4%), injection site redness (6.3%), and fever (6.3%).
The next step for the vaccine is a policy recommendation for use as a first
booster from the Centers for Disease Control and Prevention (CDC). Doses(
) of the Novavax COVID-19 Vaccine, Adjuvanted are available for use in the U.S.
pending this final step and can be located on Vaccines.gov.
Novavax' vaccine is also available for use as a booster in adults aged 18 and
older in the European Union(
), Japan(
), Australia(
), New Zealand(
), Switzerland(
), and Israel(
). In addition, a number of countries have policy recommendations allowing use
of the vaccine as a heterologous or homologous booster dose. In the U.S., the
FDA granted EUA for a two-dose primary series in adults aged 18 and older in
July(
) and for adolescents aged 12 through 17 in August(
). Following these EUA's, the CDC recommended the vaccine for use as a primary
series for both age groups.
This project has been supported in part with federal funds from the Department
of Health and Human Services (HHS); the Administration for Strategic
Preparedness and Response; Biomedical 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 number MCDC2011-001.
Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine 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 prevent
Coronavirus Disease 2019 (COVID-19) as a primary series individuals 12 years of
age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also
authorized to provide a first booster dose at least 6 months after completion
of primary vaccination with an authorized or approved COVID-19 vaccine to
individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent
COVID-19 booster vaccine is not accessible or clinically appropriate, and to
individuals 18 years of age and older who elect to receive the Novavax COVID-19
Vaccine, Adjuvanted because they would otherwise not receive a booster dose of
a COVID-19 vaccine.
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 12
years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is
also authorized to provide a first booster dose at least 6 months after
completion of primary vaccination with an authorized or approved COVID-19
vaccine to individuals 18 years of age and older for whom an FDA-authorized
mRNA bivalent COVID-19 booster vaccine is not accessible or clinically
appropriate, and to individuals 18 years of age and older who elect to receive
the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not
receive a booster dose of a COVID-19 vaccine.
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).
The CDC has published considerations related to myocarditis and pericarditis
after vaccination, including for vaccination of individuals with a history of
myocarditis or pericarditis (
).
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, anaphylaxis, paresthesia, and hypoesthesia 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 myocarditis,
--cases of pericarditis,
--cases of Multisystem Inflammatory Syndrome (MIS), in adults and children,
and
--cases of COVID-19 that results in hospitalization or death.
Complete and submit reports to VAERS online: 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 (Vaccination Providers) and EUA Full
Prescribing Information.( https://www.fda.gov/media/159897/download )
Please click to see the Fact Sheet for Recipients and Caregivers(
).
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 2degrees- 8degrees 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, BARDA, part of the
Administration for Strategic Preparedness and Response, 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 (number MCDC2011-001). JPEO-CBRND 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. 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 are being 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. The Novavax COVID-19 vaccine
has received authorization from multiple regulatory authorities globally,
including the U.S. FDA, the European Commission, and the World Health
Organization. The vaccine is currently under review by multiple regulatory
agencies worldwide, including for additional populations and indications such
as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax
is also currently evaluating its COVID-19-Influenza Combination (CIC) vaccine
candidate in a Phase 1/2 clinical trial, its quadrivalent influenza
investigational vaccine candidate, and an Omicron strain-based vaccine
(NVX-CoV2515) as well as a bivalent format 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/ ).
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and
prospects, its partnerships, the potential for subsequent orders from the U.S.
government for additional doses of NVX-CoV2373 and other potential
formulations, the timing of clinical trial results, the ongoing development of
NVX-CoV2373, NVX-CoV2515 and bivalent Omicron-based / original strain based
vaccine, a CIC investigational vaccine candidate, the scope, timing and outcome
of future regulatory filings and actions, including potential recommendations
and authorizations from the CDC, 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 evolving COVID-19 pandemic,
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, 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; unanticipated
challenges or delays in conducting clinical trials; 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
Erika Schultz | 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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SOURCE: Novavax, Inc.
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