World Health Organization SAGE Issues Interim Recommendations for Novavax COVID-19 Vaccine
PR93825
GAITHERSBURG, Md., Dec. 22, 2021 /PRNewswire=KYODO JBN/ --
- WHO Strategic Advisory Group of Experts on Immunization (SAGE) recommends
primary two-dose vaccination series of NVX-CoV2373 in persons aged 18 and older
- SAGE recommends additional third dose of NVX-CoV2373 administered to
immunocompromised persons
- Recommendation follows grant of WHO Emergency Use Listing for Novavax' vaccine
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that the World Health Organization (WHO) Strategic Advisory
Group of Experts on Immunization (SAGE) has published its interim
recommendations (
) for use of NVX-CoV2373, Novavax' recombinant nanoparticle protein-based
COVID-19 vaccine with Matrix-M(TM) adjuvant. The recommendations follow
Emergency Use Listing (EUL) of the vaccine by WHO, which will be manufactured
and marketed as Nuvaxovid(TM) COVID-19 Vaccine (recombinant, adjuvanted) by
Novavax in Europe and other markets, and as COVOVAX(TM) in India and licensed
territories by the Serum Institute of India Pvt. Limited (SII).
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"This interim recommendation from WHO provides helpful guidance for the use of
our COVID-19 vaccine as countries that rely on EUL begin their own assessment
and underscores the critical role that we expect the vaccine will play in the
global fight against the coronavirus," said Stanley C. Erck, President and
Chief Executive Officer, Novavax. "We look forward to delivering our
recombinant protein-based vaccine to hundreds of millions of people around the
world in partnership with our partner, Serum Institute of India."
WHO recommends the following:
-- A 2-dose primary vaccination series of NVX-CoV2373 in persons aged 18
years and older administered 3-4 weeks apart, as well as administration
of an additional dose of NVX-CoV2373 to immunocompromised persons
between one and three months after dose 2 of the primary series;
-- Use of the vaccine in specific populations, including persons with
comorbidities, breastfeeding women, and those living with human
immunodeficiency virus (HIV);
-- Use of NVX-CoV2373 vaccine in pregnant women if the benefits of
vaccination to the pregnant woman outweigh the potential risks; and
-- Coadministration of an inactivated seasonal influenza vaccine and any
dose of NVX-CoV2373 is acceptable.
The SAGE recommendation is based on the totality of preclinical 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.
The WHO EULs for Nuvaxovid and COVOVAX leverage Novavax' manufacturing
partnership with SII, the world's largest vaccine manufacturer by volume, which
will supply initial doses for the COVAX Facility. The EUL application for
Nuvaxovid will later be supplemented with data from additional manufacturing
sites in Novavax' global supply chain.
Novavax recently received conditional marketing authorization (
) (CMA) for Nuvaxovid in the European Union, and Novavax and SII recently
received emergency use authorization (EUA) for COVOVAX in Indonesia (
) and the Philippines (
). The vaccine is also currently under review by multiple regulatory agencies
worldwide. The company expects to submit its complete chemistry, manufacturing
and controls (CMC) data package to the U.S. FDA for review by the end of 2021.
The brand name Nuvaxovid has not yet been authorized for use in the U.S. by the
U.S. FDA.
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¡ã- 8¡ã Celsius, enabling the use of existing
vaccine supply and cold chain channels. The current assigned shelf-life of the
vaccine is 9 months.
For more information on Nuvaxovid and COVOVAX, including the Summary of Product
Characteristics, Prescribing Information and Important Safety Information, or
to request additional information please visit the following websites:
-- Novavax global authorization website (
)
-- World Health Organization (
)
-- Serum Institute of India (
)
Emergency Use Listing of Nuvaxovid(TM) and COVOVAX(TM) by the World Health
Organization
The World Health Organization (WHO) has issued Emergency Use Listing for
Nuvaxovid(TM) (SARS-CoV-2 rS vaccine [Recombinant, adjuvanted]), and
COVOVAX/Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg for active
immunization of individual 18 years of age and older for the prevention of
coronavirus disease 2019 caused by SARS-CoV-2.
Important Safety Information
-- Nuvaxovid(TM) is contraindicated in persons who have a hypersensitivity
to the active substance or to any of the excipients
-- Events of anaphylaxis have been reported with administration of COVID-
19 vaccines. Appropriate medical treatment and supervision should be
available in case of an anaphylactic reaction
-- Anxiety-related reactions, including vasovagal reactions (syncope),
hyperventilation, or stress--related reactions may occur in association
with vaccination as a response to the needle injection. It is important
that precautions are in place to avoid injury from fainting
-- Vaccination should be postponed in individuals suffering from an acute
severe febrile illness or acute infection
-- Give Nuvaxovid with caution in individuals receiving anticoagulant
therapy or those with thrombocytopenia or any coagulation disorder
(such as haemophilia) because bleeding or bruising may occur following
an intramuscular administration in these individuals
-- The efficacy of Nuvaxovid may be lower in immunosuppressed individuals
-- The duration of protection afforded by the vaccine is unknown as it is
still being determined by ongoing clinical trials
-- Individuals may not be fully protected until 7 days after their second
dose. As with all vaccines, vaccination with Nuvaxovid may not protect
all vaccine recipients
-- The most common adverse reactions observed during clinical studies
(frequency category of very common ¡Ý 1/10), were headache, nausea or
vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue
and malaise
Please visit https://www.novavaxcovidvaccine.com for the full leaflet and
adverse reaction reporting instructions.
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.
About NVX-CoV2373
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(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.
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¡ã- 8¡ã 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 Phase 3 trials.
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(TM) Adjuvant
Novavax' patented saponin-based Matrix-M(TM) 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, received Conditional Marketing Authorization from the
European Commission, Emergency Use Listing from the World Health Organization,
Emergency Use Authorization in Indonesia and the Philippines, and has been
submitted for regulatory authorization in multiple markets globally.
NanoFlu(TM), 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, which combines the company's NVX-CoV2373 and NanoFlu
vaccine candidates. These vaccine candidates incorporate Novavax' proprietary
saponin-based Matrix-M(TM) 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 Twitter (
), LinkedIn (
), Instagram (
) and Facebook (
).
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 EUL application submitted to the WHO and, by the end of
the year, to submit a complete CMC data package to the U.S. FDA, the potential
impact of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the
pandemic and protecting populations, and Novavax' expected global delivery 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 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
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
Novavax, Inc.
Erika Schultz | +1 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | +1 617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | +1 240-720-7804
Laura Keenan Lindsey | +1 202-709-7521
media@novavax.com
SOURCE: Novavax, Inc.
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