GAITHERSBURG, Md., July 19,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
biotechnology company dedicated to developing and commercializing
next-generation vaccines for serious infectious diseases, has
signed agreements with its partner, SK bioscience, for the
manufacturing and supply of a version of the Novavax COVID-19
vaccine (NVX-CoV2373) containing Omicron variant and for the
manufacture of the vaccine in prefilled syringes.
The companies signed an agreement for the technology transfer of
Novavax' proprietary COVID-19 variant antigen materials so that SK
bioscience can manufacture the drug substance targeting COVID-19
variants including the Omicron BA.5 subvariant.
"Non-clinical data generated to date demonstrate that our
COVID-19 vaccine offers broad immune responses including against
circulating variants, such as Omicron BA.5," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "We are accelerating our clinical program
evaluating an Omicron BA.5 component to our vaccine and look
forward to continuing to work with SK bioscience as an important
manufacturing partner."
In addition, the companies have signed an agreement to
manufacture and supply the Novavax COVID-19 vaccine in a prefilled
syringe. SK bioscience will begin work to enable the manufacturing
process for commercial supply of the vaccine in prefilled syringes
in 2023.
Currently, SK bioscience manufactures drug substance for the
vaccine. Novavax and SK bioscience also have a collaboration and
licensing agreement under which SK bioscience exclusively
commercializes the Novavax COVID-19 vaccine in South Korea, and with Novavax, jointly
commercializes the vaccine in Vietnam and Thailand.
Authorized Use in the U.S.
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.
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.
About the Novavax COVID-19 vaccine (NVX-CoV2373)
The Novavax COVID-19 vaccine (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™
adjuvant to enhance the immune response and stimulate high levels
of neutralizing antibodies. The Novavax COVID-19 vaccine contains
purified protein antigen and can neither replicate, nor can it
cause COVID-19.
The 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. Use of the vaccine should be in
accordance with official recommendations.
Novavax has established partnerships for the manufacture,
commercialization, and distribution of its COVID-19 vaccine
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.
The Novavax COVID-19 vaccine and the PREVENT-19 trial have been
supported in part with federal funds from the U.S. government,
including the Department of Health and Human Services (HHS); 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); 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
Novavax' vaccine under these existing agreements should it receive
a recommendation from the CDC. Novavax and the U.S. government will
determine the timing, pricing, and amounts for delivery of any
additional doses. Novavax intends to pursue additional U.S.
procurement of both its COVID-19 vaccine doses and other potential
formulations.
About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3
Trials
The Novavax COVID-19 vaccine (NVX-CoV2373) continues being
evaluated in two pivotal Phase 3 trials.
PREVENT-19 (the PRE-fusion protein
subunit Vaccine Efficacy Novavax Trial
| COVID-19) is a 2:1 randomized, placebo-controlled,
observer-blinded trial to evaluate the efficacy, safety, and
immunogenicity of the Novavax COVID-19 vaccine with Matrix-M
adjuvant in 29,960 participants 18 years of age and over in 119
locations in the U.S. and Mexico. The primary endpoint for
PREVENT-19 was the first occurrence of PCR-confirmed symptomatic
(mild, moderate, or severe) COVID-19 with onset at least seven 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%. A secondary endpoint was
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. In the trial, the Novavax
COVID-19 vaccine achieved 90.4% efficacy overall. It was generally
well-tolerated and elicited a robust antibody response after the
second dose in both studies. Full results of the trial were
published in the New England Journal of
Medicine (NEJM).
The pediatric expansion of PREVENT-19 is a 2:1 randomized,
placebo-controlled, observer-blinded trial to evaluate the safety,
effectiveness, and efficacy of the Novavax COVID-19 vaccine with
Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years
of age in 73 locations in the United
States, compared with placebo. In the pediatric trial, the
vaccine achieved its primary effectiveness endpoint
(non-inferiority of the neutralizing antibody response compared to
young adult participants 18 through 25 years of age from
PREVENT-19) and demonstrated 80% efficacy overall at a time when
the Delta variant of concern was the predominant circulating strain
in the U.S. Additionally, immune responses were about
two-to-three-fold higher in adolescents than in adults against all
variants studied.
Additionally, a trial conducted in the U.K. with 14,039
participants aged 18 years and over 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 seven days after the second study
vaccination in serologically negative (to SARS-CoV-2) adult
participants at baseline. Full results of the trial were published
in NEJM.
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.
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., 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.
*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
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 the 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; 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
Alex Delacroix | 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/novavax-announces-expanded-agreement-with-sk-bioscience-to-manufacture-covid-19-vaccine-containing-omicron-variant-and-manufacture-the-novavax-covid-19-vaccine-in-prefilled-syringes-301589101.html
SOURCE Novavax, Inc.