U.S. CDC Advisory Committee Unanimously Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Primary Series for Individuals Aged 18 and Older
PR97091
GAITHERSBURG, Md., July 20, 2022 /PRNewswire=KYODO JBN/ --
-- Recommendation follows U.S. FDA Emergency Use Authorization for the
Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary series
-- FDA has determined that first vaccine lot has met all release
specifications and is acceptable for use under Emergency Use
Authorization
-- Novavax expects to ship doses to the U.S. Government-designated
distribution center in the coming days
-- Novavax' vaccine is the first FDA-authorized and ACIP-recommended
protein-based COVID-19 vaccine in the U.S.
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that the U.S. Centers for Disease Control and Prevention's
(CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to
recommend the use of the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose
primary series in individuals aged 18 and older.
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The recommendation follows the Emergency Use Authorization
granted by the U.S. Food and Drug Administration (FDA). ACIP will
submit its recommendation to the Director of the CDC for review and endorsement.
"We think vaccine choice is important, particularly as we expect to see ongoing
surges of COVID-19 and work to increase vaccination rates," said Stanley C.
Erck, President and Chief Executive Officer, Novavax. "With demonstrated
efficacy and a reassuring safety profile, our vaccine is the country's first
protein-based option."
The Committee based its recommendation on use in individuals aged 18 and older
on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled
29,960 participants aged 18 years and older 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 (ARs) following administration of any dose of the vaccine,
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, solicited ARs following
administration of any dose of the vaccine 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%).
In addition to the FDA EUA, the Novavax COVID-19 vaccine has received
conditional authorization for use in individuals aged 18 and older from
multiple regulatory agencies worldwide, including the European Commission
(EC), and Emergency Use Listing from the World Health Organization
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; 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 has not been approved or licensed by
the U.S. 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://c212.net/c/link/?t=0&l=en&o=3598612-1&h=345517487&u=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Fclinical-considerations%2Fmanaging-anaphylaxis.html&a=the+Centers+for+Disease+Control+(CDC)+and+Prevention+guidelines).
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://c212.net/c/link/?t=0&l=en&o=3598612-1&h=4213333230&u=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F159897%2Fdownload&a=Novavax+COVID-19+Vaccine%2C+Adjuvanted+Fact+Sheet+for+Healthcare+Providers+Administering+Vaccine+(Vaccine+Providers)+and+EUA+Full+Prescribing+Information.)
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 (number 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 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, 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 endorsement from the
Director of the Centers for Disease Control and Prevention, Novavax' plans to
file a Biologics License Application with the FDA in 2023, 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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