FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older
PR96399
GAITHERSBURG, Md., June 7, 2022 /ASIANET=KYODO JBN/ --
--Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug
Administration Vaccines and Related Biological Products Advisory Committee
--If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19
vaccine would become the first protein-based COVID-19 vaccine available 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 the U.S. Food and Drug Administration (FDA) Vaccines and
Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one
abstention, to recommend that the FDA grant Emergency Use Authorization (EUA)
for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years
and over.
Logo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg
"The advisory committee's positive recommendation acknowledges the strength of
our data and the importance of a protein-based COVID-19 vaccine developed using
an innovative approach to traditional vaccine technology," said Stanley C.
Erck, President and Chief Executive Officer, Novavax. "In today's VRBPAC
meeting, we heard the overwhelming support for our vaccine from physicians,
healthcare organizations, and consumers who are eagerly anticipating a
protein-based vaccine option. Consistent with submissions to regulatory
authorities worldwide, we have already submitted an amendment with updated
manufacturing information for the EUA to the FDA for review. We look forward to
collaborating with the FDA as it makes its final decision."
The VRBPAC considered data from the pivotal Phase 3 clinical trial, PREVENT-19,
which enrolled approximately 30,000 participants aged 18 years and older in the
U.S. and Mexico and was published in the New England Journal of Medicine
In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy (95%
confidence interval [CI], 82.9 to 94.6; P<0.001) with a reassuring safety
profile. Serious and severe adverse events were low in number and balanced
between vaccine and placebo groups. The most common adverse reactions observed
during the trial (frequency category of very common greater than or equal to
1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site
tenderness/pain, fatigue, and malaise. The data showed that overall the rate of
myocarditis was balanced between the vaccine and placebo arms (0.007% and
0.005%) and in the post-crossover portions of Novavax trials the observed cases
were all within the expected rate.
The FDA considers the recommendations of VRBPAC when making decisions on EUA.
The Novavax COVID-19 vaccine has received authorization for use in individuals
aged 18 and over from more than 40 countries in addition to Emergency Use
Listing (https://c212.net/c/link/?t=0&l=en&o=3560647-1&h=482690262&u=https%3A%2F%2Fir.novavax.com%2F2021-12-20-World-Health-Organization-Grants-Second-Emergency-Use-Listing-for-Novavax-COVID-19-Vaccine&a=Emergency+Use+Listing) from the World Health Organization.
Authorization in the U.S.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use
in the U.S.
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. 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.
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 degrees - 8 degrees 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 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 the NVX-CoV2373 Phase 3 Trials
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 NVX-CoV2373 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, NVX-CoV2373 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
The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled,
observer-blinded trial to evaluate the safety, effectiveness, and efficacy of
NVX-CoV2373 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, NVX-CoV2373 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.
PREVENT-19 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 U.S. Department of Health and Human Services
(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).
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(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 conditional authorization from multiple
regulatory authorities globally, including the European Commission and the
World Health Organization. The vaccine is currently under review by multiple
regulatory agencies worldwide and will soon be under review in the U.S. for use
in adults, 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, a
COVID-seasonal influenza investigational vaccine candidate, the scope, timing
and outcome of future regulatory filings and actions, including the FDA's
upcoming decision regarding EUA for Novavax' COVID-19 vaccine candidate, and
Novavax' subsequent discussions with 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 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 | 240-268-2022
ir@novavax.com
Media
Ali Chartan | 240-720-7804
media@novavax.com
SOURCE Novavax, Inc.
本プレスリリースは発表元が入力した原稿をそのまま掲載しております。また、プレスリリースへのお問い合わせは発表元に直接お願いいたします。
このプレスリリースには、報道機関向けの情報があります。
プレス会員登録を行うと、広報担当者の連絡先や、イベント・記者会見の情報など、報道機関だけに公開する情報が閲覧できるようになります。
