The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen's COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in
'
Prevention of severe disease; protection against COVID-related hospitalization and death
The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied,[i] 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.
The Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO)), with no reported cases among participants
'These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,' said
In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. Moderate COVID-19 disease was defined as laboratory-confirmed SARS-CoV-2 and one or more of the following: evidence of pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation above 93%, abnormal respiratory rate (20); or two or more systemic symptoms suggestive of COVID-19.
Protection was generally consistent across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including
Multi-continent Study Provides Clinical Data on Multiple Emerging Viral Mutations
The ENSEMBLE study results include efficacy against newly emerging strains of coronavirus, including some highly infectious variants present in the US,
'These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,' said
Trial participants of the phase 3 ENSEMBLE study continue to be followed for up to two years for assessments of safety and efficacy. Therefore, these data may be updated based on ongoing analysis. The comprehensive available data set will be submitted to a peer-reviewed journal in the coming weeks.
Phase 3 ENSEMBLE Study Safety Data
The analysis included a concurrent review of the available Phase 3 ENSEMBLE study safety data by the Data and Safety Monitoring Board (DSMB), an independent group of experts, that did not report any significant safety concerns relating to the vaccine. A review of adverse events indicated that a single-dose of Janssen's COVID-19 vaccine candidate was generally well-tolerated.
The safety profile was consistent with other vaccine candidates using Janssen's AdVac technology among more than 200,000 people to date. Overall fever rates were 9% and Grade 3 fever 0.2%. Overall serious adverse events (SAEs) reported were higher in participants
Janssen Vaccine Candidate Access and Distribution
The Company is committed to bringing an affordable COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending regulatory authorizations.
In addition, the Janssen vaccine candidate is compatible with standard vaccine distribution channels. If authorized, Janssen's single-dose vaccine candidate is estimated to remain stable for two years at -20-degreeC (-4-degreeF), at least three months of which can be at temperatures of 2-8-degreeC (36-degreeF-46-degreeF). The Company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines.
The Company intends to file for
Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older.
The ENSEMBLE study was designed to evaluate the safety and efficacy of the Janssen vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.
Phase 3 ENSEMBLE Study Demographics
The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34% (N= 14,672) of participants over age 60.
The study enrolled 44% (N=19,302) of participants in
Forty-five percent of participants are female, 55% male.
Among participants globally, 59% are White/Caucasian; 45% are Hispanic and/or Latinx; 19% are Black/
Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19 (overall 41%, obesity (28.5%), type 2 diabetes (7.3%), hypertension (10.3%), HIV (2.8%); also other immunocompromised participants were in the study.
Janssen's Vaccine Technology
The investigational Janssen COVID-19 vaccine candidate leverages the Company's AdVac vaccine platform, which was also used to develop and manufacture Janssen's
The Janssen AdVac viral vector technology can induce potent and long-lasting humoral and cellular immune responses, enabling the pursuit of vaccines for disease targets that are currently unpreventable or untreatable.
ENSEMBLE has been funded in whole or in part with Federal funds from the
Janssen has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola. In
The Janssen Pharmaceutical Companies entered into a collaboration with the
Janssen's COVID-19 vaccine program has been designed to be thorough and driven by science. As such, the Company is also investigating immune responses for different doses and dosing regimens as well as studying a two-dose regimen of its COVID-19 vaccine candidate for efficacy in the Phase 3 ENSEMBLE 2 study.
About
At
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
The company plans to hold an investor webcast to share the results and provide opportunity for Q&A today at
Notice to Investors Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding development of its COVID-19 vaccine candidate. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or
Contact:
Tel: +1 202-569-5086
Email: JSargen3@its.jnj.com
(C) 2021 Electronic News Publishing, source