Johnson & Johnson has announced topline efficacy and safety data from the Phase III ENSEMBLE clinical trial, demonstrating that the investigational single-dose Covid-19 vaccine in development at 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 III 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 the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.
“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-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” said Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson.
Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said: “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. 85% efficacy in preventing severe Covid-19 disease and prevention of Covid-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of Covid-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”
Protection was generally consistent across race, age groups, including adults over 60
years of age and across all variants and regions studied, including South Africa where 95% of cases of Covid-19 were due to infection with a SARSCoV-2 variant from the B.1.351 lineageii.
The company intends to file for U.S. Emergency Use Authorization (EUA) in early February 2022 and expects to have product available to ship immediately following authorisation. It expects to share more information on specifics of deployment as authorisations are secured and contracts are finalised. The company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organisations.
The ENSEMBLE study is a randomised, 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.