- Homologous boosting with the prototype Novavax COVID-19
vaccine induced robust antibody titers for Omicron BA.1, BA.2, and
BA.5
- Study 307 (Lot Consistency) achieved its primary endpoint,
showing that three vaccine lots induced a comparable immune
response thereby demonstrating the consistency of the manufacturing
process
- A durable immunogenicity response was observed following
primary vaccination as well as boosting which matched the levels
previously associated with protection
GAITHERSBURG, Md., Oct. 12,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
biotechnology company dedicated to developing and commercializing
next-generation vaccines for serious infectious diseases, today
presented data from the Phase 3 PREVENT-19 trial and Study 307 (Lot
Consistency) at the World Vaccine Congress Europe 2022. PREVENT-19
data in both adults aged 18 and older and adolescents aged 12
through 17 showed the prototype Novavax COVID-19 vaccine
(NVX-CoV2373) achieved its pre-specified immunologic endpoint.
Study 307 (Lot Consistency) met its primary endpoint, showing that
three lots of the Novavax COVID-19 vaccine tested as a heterologous
booster induced consistent immune responses in previously
vaccinated adults aged 18 to 49.
"These data further demonstrate the consistent immunogenicity
and safety profile of the Novavax COVID-19 vaccine as a booster,
regardless of previous vaccine history," said Gregory M. Glenn, M.D., President of Research
and Development, Novavax. "These data are an early indication that
our vaccine may be effective against variants such as Omicron. We
have ongoing trials further exploring the Novavax COVID-19
vaccine's potential as an effective booster against these variants,
including BA.4/5, and look forward to sharing these data."
PREVENT-19 adult and adolescent homologous boosting
In the PREVENT-19 trial, a single homologous booster dose was
given to select adult participants aged 18 and older, approximately
eight or 11 months after their primary series. Following a booster
dose, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
anti-spike (anti-S) Immunoglobulin G (IgG; a type of antibody)
levels increased significantly relative to pre-boost levels, rising
above the level correlated with 95% vaccine efficacy in a recent
USG study. Neutralizing antibodies against the prototype
strain also increased by 34- to 27-fold compared to pre-boost
levels when boosted at eight or 11 months. Boosting also increased
IgG and human angiotensin converting enzyme 2 (hACE2) receptor
inhibition antibody levels against Omicron BA.1, BA.2, and BA.5
variants, with levels that are comparable to those observed in
Phase 3 efficacy studies.
In the pediatric expansion of PREVENT-19 which evaluated
boosting in adolescents aged 12 through 17, a single homologous
booster dose was evaluated for anti-S IgG, hACE2 receptor
inhibition and neutralization antibody responses. Following
boosting, neutralizing titers were 2.7-fold higher than those seen
with primary vaccination, and a significant boost was observed for
antibody against Omicron BA.1, BA.2, and BA.5.
In both adults and adolescents, a third dose of the Novavax
COVID-19 vaccine decreased the antigenic distance between
SARS-CoV-2 variant and prototype virus strains, suggesting benefit
for the prevention of COVID-19 against contemporary variants such
as Omicron. Additionally, in both adults and adolescents, booster
doses were well tolerated, with mostly mild to moderate
reactogenicity that was of short duration.
Study 307 (Lot Consistency) adult homologous and
heterologous boosting
Study 307 (Lot Consistency) achieved its primary endpoint,
showing that three lots of the Novavax COVID-19 vaccine induced
consistent immune responses in adults aged 18 to 49. Further,
anti-S IgG titers were within the range previously found to
correlate with high efficacy in the PREVENT-19 Phase 3 trial.
Safety was also consistent across lots, with no serious related
treatment-emergent adverse events (AE). These findings confirm a
consistent vaccine manufacturing process.
Further, heterologous boosting responses were consistent across
participants who received primary vaccines from Moderna, Pfizer, or
Johnson & Johnson, with IgG levels approximating levels
observed in PREVENT-19.
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 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 Journal of Medicine.
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 U.S., 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.
About Study 307 (Lot Consistency)
Study 307 (Lot Consistency) evaluated three different lots of
the Novavax COVID-19 vaccine in approximately 900 adults aged 18
through 49, who received an initial primary series of the Novavax
COVID-19 vaccine or other authorized or approved vaccines and a
subset who had also received a booster shot with an authorized or
approved COVID-19 vaccine at least six months prior. Participants
were boosted with a single dose of the Novavax COVID-19 vaccine.
Immunogenicity and safety were assessed, along with a comparison of
IgG levels based on the vaccine that was used for the primary
series. The study achieved its primary endpoint, showing that
three lots of the Novavax COVID-19 vaccine tested induced
consistent immune responses. Further, anti-S IgG titers were within
the range previously found to correlate with high efficacy in the
PREVENT-19 Phase 3 trial. Safety was also consistent across lots,
with no serious related treatment-emergent AEs. These findings
confirm a consistent vaccine manufacturing process.
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 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 the 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.
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. Food and Drug
Administration, the European Commission, and the World Health
Organization. The vaccine is currently under review by multiple
regulatory agencies worldwide, including for additional populations
and indications such as adolescents and as a booster. In addition
to its COVID-19 vaccine, Novavax is also currently evaluating its
COVID-19-Influenza Combination vaccine candidate in a Phase 1/2
clinical trial, its quadrivalent influenza investigational vaccine
candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as
well as a bivalent format 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.
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 NVX-CoV2515 and bivalent Omicron-based / original strain
based vaccine, a COVID-seasonal influenza combination
investigational vaccine candidate, its quadrivalent 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, intended utilization, 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
Erika Schultz | 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.