Johnson & Johnson announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.
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 percent 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 percent in the United States, 66percent in Latin America and 57 percent in South Africa, 28 days post-vaccination.
The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, 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 who had received the Janssen COVID-19 vaccine, 28 days post-vaccination.
The ENSEMBLE study results include efficacy against newly emerging strains of coronavirus, including some highly infectious variants present in the US, Latin America and South Africa. The Phase 3 ENSEMBLE trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.
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.
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°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F). 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 U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization. It expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized. The company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.
The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates.
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 Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).
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 February 2020, Janssen and BARDA began work on the development of a COVID-19 vaccine based on Janssen’s AdVac technology.
The Janssen Pharmaceutical Companies entered into a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of the preventive vaccine candidate for COVID-19.
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.
