NEW BRUNSWICK – Johnson & Johnson announced key efficacy and safety data from the ENSEMBLE Phase 3 clinical trial Friday, demonstrating that the investigational single-dose COVID-19 vaccine is in development at its Janssen Pharmaceutical Companies meeting all endpoints primary and secondary key.
Johnson & Johnson embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single injection vaccine. . Our goal from the beginning has been to create a simple and effective solution for as many people as possible and to have the maximum impact to help end the pandemic, ”said Alex Gorsky, President, Board of Directors and CEO of Johnson & Johnson in written communication.
“We are proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere,” he added.
The primary safety and efficacy data are based on 43,783 participants accumulating 468 symptomatic cases of COVID-19.
The ENSEMBLE Phase 3 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 after vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate vaccine had an overall efficacy of 66 percent in preventing moderate to severe COVID-19, 28 days after vaccination. The start 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, 66 percent in Latin America, and 57 percent in South Africa, 28 days after vaccination.
The candidate vaccine was 85 percent effective in preventing serious disease in all regions studied, 28 days after vaccination in all adults over 18 years of age. Efficacy against severe disease increased over time, and no cases were reported in participants vaccinated after day 49.
Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death 28 days after vaccination. There was a clear effect of the vaccine in COVID-19 cases that required medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO)), with no reported cases among participants who had received the Janssen vaccine COVID-19, 28 days after vaccination.
“These first-line results with a single injection COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of serious disease, by providing an effective and well-tolerated vaccine with a single immunization, is a critical component of the global public health response, ”said Paul Stoffels, MD, Executive Committee Vice President and Chief Scientific Officer from Johnson & Johnson. “The World Health Organization considers a single injection vaccine to be the best option in pandemic settings as it improves access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 illness and preventing COVID-19-related medical interventions will potentially protect hundreds of millions of people from severe and fatal COVID-19 outcomes. It also offers hope to help ease the enormous burden on health systems and communities, ”he added.
In the study, the definition of severe COVID-19 illness included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic disease, 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 percent, abnormal respiratory rate (≥20); or two or more systemic symptoms that suggest COVID-19.
Protection was generally consistent across all races, age groups, including adults older than 60 years (N = 13,610), and across all variants and regions studied, including South Africa, where nearly all COVID-19 cases (95 %) were due to infection. with a variant of SARS-CoV-2 from the B.1.351 lineage.
The ENSEMBLE study results include efficacy against new emerging strains of coronavirus, including some highly infectious variants present in the United States, Latin America, and South Africa. The ENSEMBLE Phase 3 trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when the spread of the disease has accelerated around the world, resulting in people have greater exposure to the virus.
Participants in the phase 3 trial of the ENSEMBLE study continue to be followed for up to two years to assess safety and efficacy. Therefore, this data can be updated based on ongoing analysis. The full set of available data will be submitted to a peer-reviewed journal in the coming weeks.
Safety Data from the ENSEMBLE Phase 3 Study
The analysis included a simultaneous review of the safety data from the ENSEMBLE phase 3 study available by the Data and Safety Monitoring Board (DSMB), an independent group of experts, which did not report any significant safety concerns related to the vaccine. A review of adverse events indicated that a single dose of Janssen’s COVID-19 candidate vaccine 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 percent and grade 3 fever 0.2 percent. Reported serious adverse events (SAEs) were generally higher in participants receiving placebo compared to the active vaccine candidate. Anaphylaxis was not observed.
Access and Distribution of Janssen Vaccine Candidates
The Company is committed to offering an affordable non-profit COVID-19 vaccine for emergency pandemic use, pending regulatory clearances.
Additionally, the Janssen vaccine candidate is compatible with standard vaccine distribution channels. If licensed, the Janssen single dose candidate vaccine is expected to be stable for two years at -4 ° F (-20 ° C), of which at least three months may be at 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 drugs.
The Company intends to apply for the United States Emergency Use Authorization (US). In early February and expect to have the product available to ship immediately after authorization. He looks forward to sharing more information on specifics of the implementation as authorizations are obtained and contracts are finalized. The Company’s anticipated manufacturing schedule will allow it to meet its 2021 supply commitments, including those signed with governments and global organizations.