Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial
PR90073
GAITHERSBURG, Md., June 14, 2021 /PRNewswire=KYODO JBN/ --
-- 93% efficacy against predominantly circulating Variants of Concern and
Variants of Interest
-- 91% efficacy in high-risk populations
-- 100% efficacy against variants "not considered Variants of
Concern/Interest"
-- All COVID-19 hospitalizations/death occurred in the placebo group
-- Company to host investor conference call today at 8:30 am ET
Novavax, Inc. (Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant
nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection
against moderate and severe disease, 90.4% efficacy overall, and met the
primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled
29,960 participants across 119 sites in the U.S. and Mexico to evaluate
efficacy, safety and immunogenicity, with an emphasis on recruiting a
representative population of communities and demographic groups most impacted
by the disease.
"Today, Novavax is one step closer to addressing the critical and persistent
global public health need for additional COVID-19 vaccines. These clinical
results reinforce that NVX-CoV2373 is extremely effective and offers complete
protection against both moderate and severe COVID-19 infection," said Stanley
C. Erck, President and Chief Executive Officer, Novavax. "Novavax continues to
work with a sense of urgency to complete our regulatory submissions and deliver
this vaccine, built on a well understood and proven platform, to a world that
is still in great need of vaccines."
The company intends to file for regulatory authorizations in the third quarter,
upon completion of the final phases of process qualification and assay
validation needed to meet chemistry, manufacturing and controls (CMC)
requirements. Upon regulatory approvals, Novavax remains on track to reach
manufacturing capacity of 100 million doses per month by the end of the third
quarter and 150 million doses per month by the end of the fourth quarter of
2021.
"PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and
safety profile," said Gregory M. Glenn, M.D., President of Research and
Development, Novavax. "These data show consistent, high levels of efficacy and
reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic
evolution of the virus. Our vaccine will be a critical part of the solution to
COVID-19 and we are grateful to the study participants and trial staff who made
this study possible, as well as our supporters, including the U.S. Government."
Click here (
) to view multimedia content, including B-roll, an illustrated fact sheet and
other resources that accompany this press release.
Results: Consistent, high efficacy among circulating variants
In the placebo-controlled, observer-blinded study randomized 2:1, NVX-CoV2373
demonstrated overall efficacy of 90.4% (95% CI: 82.9, 94.6), achieving its
primary endpoint. Seventy-seven cases were observed: 63 in the placebo group
and 14 in the vaccine group. All cases observed in the vaccine group were mild
as defined by the trial protocol. Ten moderate cases and four severe cases were
observed, all in the placebo group, yielding a vaccine efficacy of 100% (95%
CI: 87.0, 100) against moderate or severe disease.
Efficacy endpoints were accrued from January 25 through April 30, 2021 - a time
when the Alpha (B.1.1.7) variant, first identified in the U.K., became the
predominant strain in the U.S. Other strains, including Variants of Interest
(VoI) and Variants of Concern (VoC), were also on the rise during the
PREVENT-19 endpoint accrual window. Click here for CDC definitions of variants
(
).
Sequence data are available for 54 of the 77 cases. PREVENT-19 met its key
secondary endpoint, demonstrating 100% efficacy (95% CI: 80.8, 100) against
variants not considered VoC/VoI. Of the sequenced cases, 35 (65%) were VoC, 9
(17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which
represented 82% of the cases, vaccine efficacy was 93.2% (95% CI: 83.9, 97.1),
achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI
cases were in the placebo group and 6 were in the vaccine group.
NVX-CoV2373 also showed success among "high-risk" populations (defined as over
age 65, under age 65 with certain comorbidities or having life circumstances
with frequent COVID-19 exposure): vaccine efficacy was 91.0% (95% CI: 83.6,
95.0), with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the
vaccine group.
Results: Reasserting a favorable safety profile
Preliminary safety data from PREVENT-19 showed the vaccine to be generally
well-tolerated. Serious and severe adverse events were low in number and
balanced between vaccine and placebo groups. No single adverse event term was
reported by more than 1% of participants. In assessing reactogenicity 7 days
after Dose 1 and Dose 2, injection site pain and tenderness, generally mild to
moderate in severity, were the most common local symptoms, lasting less than 3
days. Fatigue, headache and muscle pain were the most common systemic symptoms,
lasting less than 2 days.
Study Endpoints
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%.
Novavax expects to share further details of the PREVENT-19 trial results as
additional data become available. Further analyses of the trial are ongoing and
will be shared via preprint servers as well as submitted to peer-review
journals for publication.
The placebo-controlled portion of PREVENT-19 continues in adolescents from 12
to less than 18 years of age, which recently completed enrollment with 2,248
participants.
Variant Virus Strains
The CDC has defined Variant of Interest (VoI) as a variant with genetic markers
that have been associated with changes to receptor binding, reduced
neutralization by antibodies generated against previous infection or
vaccination, or predicted increase in transmissibility or disease severity. A
Variant of Concern (VoC) is defined as a variant for which there is evidence of
an increase in transmissibility, more severe disease, significant reduction in
neutralization by antibodies generated during previous infection or
vaccination, reduced effectiveness of treatments or vaccines, or diagnostic
detection failures.
About PREVENT-19
PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial |
COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded study to
evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with
Matrix-M(TM) adjuvant in 29,960 participants 18 years of age and older in 119
locations in the United States and Mexico, compared with placebo.
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 (NIAID),
part of the National Institutes of Health (NIH) at HHS. BARDA is providing up
to $1.75 billion under a Department of Defense agreement.
Conference Call
Novavax will host a conference call today at 8:30am ET. The dial-in numbers for
the conference call are (866) 652-5200 (Domestic) or (412) 317-6060
(International). Participants will be prompted to request to join the Novavax,
Inc. call. A replay of the conference call will be available starting at 7:30
p.m. ET on June 14, 2021, until 11:59 p.m. ET on June 21, 2021. To access the
replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088
(International) and use passcode 10157478.
A webcast of the conference call can also be accessed on the Novavax website at
novavax.com/events (
). A replay of the webcast will be available on the Novavax website until
September 14, 2021.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate 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. In preclinical studies, NVX-CoV2373
induced antibodies that blocked the binding of spike protein to cellular
receptors and provided protection from infection and disease. It was generally
well-tolerated and elicited robust antibody response in Phase 1/2 clinical
testing.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the
U.K. that demonstrated efficacy of 96.4% against the original virus strain,
86.3% against the B.1.1.7 (Alpha) variant and 89.7% overall; and the PREVENT-19
trial in the U.S. and Mexico that began in December 2020. It is also being
tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b
trial in South Africa that demonstrated 55% efficacy overall in HIV-negative
participants and 48.6% efficacy against the B.1.351 (Beta) variant, and a Phase
1/2 study in the U.S. and Australia.
NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing
vaccine supply chain channels for its distribution. It is packaged in a
ready-to-use liquid formulation in 10-dose vials.
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 combines the power and speed of
genetic engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. Novavax is conducting
late-stage clinical trials for NVX-CoV2373, its vaccine candidate against
SARS-CoV-2, the virus that causes COVID-19. NanoFlu(TM), its quadrivalent
influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase
3 clinical trial in older adults and will be advanced for regulatory
submission. Both 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 (
) and LinkedIn (
).
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development
of its vaccine and adjuvant products are forward-looking statements. Novavax
cautions that these forward-looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially from
those expressed or implied by such statements. These risks and uncertainties
include those identified under the heading "Risk Factors" in the Novavax Annual
Report on Form 10-K for the year ended December 31, 2020, 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
http://sec.gov, 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
Alison Chartan | +1 240-720-7804
Laura Keenan | +1 202-709-7521
Amy Speak | +1 617-420-2461
media@novavax.com
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SOURCE: Novavax, Inc.
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