Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, today
announced that NVX-CoV2373, its protein-based COVID-19 vaccine
candidate, met the primary endpoint, with a vaccine efficacy of
89.3%, in its Phase 3 clinical trial conducted in the United
Kingdom (UK). The study assessed efficacy during a period with high
transmission and with a new UK variant strain of the virus emerging
and circulating widely. It was conducted in partnership with the UK
Government’s Vaccines Taskforce. Novavax also announced successful
results of its Phase 2b study conducted in South Africa.
“With today’s results from our UK Phase 3 and
South Africa Phase 2b clinical trials, we have now reported data on
our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over
20,000 participants. In addition, our PREVENT-19 US and Mexico
clinical trial has randomized over 16,000 participants toward our
enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to
demonstrate not only high clinical efficacy against COVID-19 but
also significant clinical efficacy against both the rapidly
emerging UK and South Africa variants,” said Stanley C. Erck,
President and Chief Executive Officer, Novavax. “NVX-CoV2373 has
the potential to play an important role in solving this global
public health crisis. We look forward to continuing to work with
our partners, collaborators, investigators and regulators around
the world to make the vaccine available as quickly as
possible.”
NVX-CoV2373 contains a full-length, prefusion
spike protein made using Novavax’ recombinant nanoparticle
technology and the company’s proprietary saponin-based Matrix-M™
adjuvant. The purified protein is encoded by the genetic sequence
of the SARS-CoV-2 spike (S) protein and is produced in insect
cells. It can neither cause COVID-19 nor can it replicate, is
stable at 2°C to 8°C (refrigerated) and is shipped in a
ready-to-use liquid formulation that permits distribution using
existing vaccine supply chain channels.
UK Phase 3 Results: 89.3%
Efficacy
The study enrolled more than 15,000 participants
between 18-84 years of age, including 27% over the age of 65. The
primary endpoint of the UK Phase 3 clinical trial is 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.
The first interim analysis is based on 62 cases,
of which 56 cases of COVID-19 were observed in the placebo group
versus 6 cases observed in the NVX-CoV2373 group, resulting in a
point estimate of vaccine efficacy of 89.3% (95% CI: 75.2 – 95.4).
Of the 62 cases, 61 were mild or moderate, and 1 was severe (in
placebo group).
Preliminary analysis indicates that the UK
variant strain that was increasingly prevalent was detected in over
50% of the PCR-confirmed symptomatic cases (32 UK variant, 24
non-variant, 6 unknown). Based on PCR performed on strains from 56
of the 62 cases, efficacy by strain was calculated to be 95.6%
against the original COVID-19 strain and 85.6% against the UK
variant strain [post hoc].
The interim analysis included a preliminary
review of the safety database, which showed that severe, serious,
and medically attended adverse events occurred at low levels and
were balanced between vaccine and placebo groups.
“These are spectacular results, and we are very
pleased to have helped Novavax with the development of this
vaccine. The efficacy shown against the emerging variants is also
extremely encouraging. This is an incredible achievement that will
ensure we can protect individuals in the UK and the rest of the
world from this virus,” said Clive Dix, Chair, UK Vaccine
Taskforce.
Novavax expects to share further details of the
UK trial results as additional data become available. Additional
analysis on both trials is ongoing and will be shared via
prepublication servers as well as submitted to a peer-reviewed
journal for publication. The company initiated a rolling submission
to the United Kingdom’s regulatory agency, the MHRA, in
mid-January.
South Africa
Results: Approximately 90% of COVID-19
cases attributed to South Africa escape variant
In the South Africa Phase 2b clinical trial, 60%
efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate
and severe COVID-19 disease was observed in the 94% of the study
population that was HIV-negative. Twenty-nine cases were observed
in the placebo group and 15 in the vaccine group. One severe case
occurred in the placebo group and all other cases were mild or
moderate. The clinical trial also achieved its primary efficacy
endpoint in the overall trial population, including HIV-positive
and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 –
72.8).
This study enrolled over 4,400 patients
beginning in August 2020, with COVID-19 cases counted from
September through mid-January. During this time, the triple mutant
variant, which contains three critical mutations in the receptor
binding domain (RBD) and multiple mutations outside the RBD, was
widely circulating in South Africa. Preliminary sequencing data is
available for 27 of 44 COVID-19 events; of these, 92.6% (25 out of
27 cases) were the South Africa escape variant.
Importantly in this trial, approximately 1/3 of
the patients enrolled (but not included in the primary analyses
described above) were seropositive, demonstrating prior COVID-19
infection at baseline. Based on temporal epidemiology data in the
region, the pre-trial infections are thought to have been caused by
the original COVID-19 strain (i.e., non-variant), while the
subsequent infections during the study were largely variant virus.
These data suggest that prior infection with COVID-19 may not
completely protect against subsequent infection by the South Africa
escape variant, however, vaccination with NVX-CoV2373 provided
significant protection.
“The 60% reduced risk against COVID-19 illness
in vaccinated individuals in South Africans underscores the value
of this vaccine to prevent illness from the highly worrisome
variant currently circulating in South Africa, and which is
spreading globally. This is the first COVID-19 vaccine for which we
now have objective evidence that it protects against the variant
dominating in South Africa,” says Professor Shabir Maddi, Executive
Director of the Vaccines and Infectious Diseases Analytics Research
Unit (VIDA) at Wits, and principal investigator in the Novavax
COVID-19 vaccine trial in South Africa. “I am encouraged to see
that Novavax plans to immediately begin clinical development on a
vaccine specifically targeted to the variant, which together with
the current vaccine is likely to form the cornerstone of the fight
against COVID-19.”
Novavax initiated development of new constructs
against the emerging strains in early January and expects to select
ideal candidates for a booster and/or combination bivalent vaccine
for the new strains in the coming days. The company plans to
initiate clinical testing of these new vaccines in the second
quarter of this year.
“A primary benefit of our adjuvanted platform is
that it uses a very small amount of antigen, enabling the rapid
creation and large-scale production of combination vaccine
candidates that could potentially address multiple circulating
strains of COVID-19,” said Gregory M. Glenn, M.D., President of
Research and Development, Novavax. “Combined with the safety
profile that has been observed in our studies to-date with our
COVID-19 vaccine, as well as prior studies in influenza, we are
optimistic about our ability to rapidly adapt to evolving
conditions.”
The Coalition for Epidemic Preparedness
Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373
for this Phase 2b clinical trial, which was supported in part by
a $15 million grant from the Bill & Melinda
Gates Foundation.
Significant progress on PREVENT-19
Clinical Trial in US and Mexico
To date, PREVENT-19 has randomized over 16,000
participants and expects to complete our targeted enrollment of
30,000 patients in the first half of February. PREVENT-19 is
being conducted with support from the U.S. government partnership
formerly known as Operation Warp Speed, which includes the
Department of Defense, the Biomedical Advanced Research and
Development Authority (BARDA), part of the U.S. Department of
Health and Human Services (HHS) Office of the Assistant Secretary
for Preparedness and Response, and the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH) at HHS. BARDA is also providing up to
$1.75 billion under a Department of Defense agreement.
PREVENT-19 (the PRE-fusion
protein subunit Vaccine Efficacy
Novavax Trial |
COVID-19) is a Phase 3, randomized,
placebo-controlled, observer-blinded study in the US and Mexico to
evaluate the efficacy, safety and immunogenicity of NVX-CoV2373
with Matrix-M in up to 30,000 subjects 18 years of age and older
compared with placebo. The trial design has been harmonized to
align with other Phase 3 trials conducted under the auspices of
Operation Warp Speed, including the use of a single external
independent Data and Safety Monitoring Board to evaluate safety and
conduct an unblinded review when predetermined interim analysis
events are reached.
The trial’s primary endpoint is the prevention
of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint
is the prevention of PCR-confirmed, symptomatic moderate or severe
COVID-19. Both endpoints will be assessed at least seven days after
the second study vaccination in volunteers who have not been
previously infected with SARS-CoV-2.
Conference Call
Novavax will host a conference call today at
4:30pm ET. The dial-in numbers for the conference call are (877)
212-6076 (Domestic) or (707) 287-9331 (International), passcode
7470222. A replay of the conference call will be available starting
at 7:30 p.m. ET on January 28, 2021 until 7:30 p.m. ET on February
4, 2021. To access the replay by telephone, dial (855) 859-2056
(Domestic) or (404) 537-3406 (International) and use passcode
7470222.
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 April
28, 2021.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate
engineered from the genetic sequence 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 adjuvanted with
Novavax’ patented saponin-based Matrix-M™ 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. Over 37,000 participants have
participated to date across four different clinical studies in five
countries. NVX-CoV2373 is currently being evaluated in two pivotal
Phase 3 trials: a trial in the U.K that completed
enrollment in November and the PREVENT-19 trial in
the U.S. and Mexico that began in December.
About Matrix-M™
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 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™, 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™ 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.
Novavax 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, 2019, and Quarterly Report on
Form 10-Q for the period ended September 30, 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 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 (Trahan) Schultz
ir@novavax.com
240-268-2022
Solebury Trout
Jennifer Porcelli
jporcelli@soleburytrout.com
617-974-8659
Media
Edna Kaplan
media@novavax.com
617-974-8659
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