Johnson & Johnson announced topline efficacy and safety data from its 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.
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 data are based on 43,783 trial participants accruing 468 symptomatic cases of COVID-19.
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 U.S., 66% in Latin America and 57% in South Africa, 28 days post-vaccination.
The two vaccines authorized in the U.S., Pfizer/BioNTech and Moderna, were shown to be close to 95% effective in preventing symptomatic illness in pivotal trials when given in two doses. However the trials were conducted mainly in the U.S. and before new variants emerged. Recently Moderna reported early data that found its COVID-19 vaccine retains neutralizing activity against variants first identified in the U.K. and South Africa, but "out of an abundance of caution" the drugmaker is launching a clinical program to boost immunity to emerging variants.
According to J&J, the Janssen vaccine candidate is compatible with standard vaccine distribution channels. The 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).
J&J 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 has said it plans to deliver 1 billion doses in 2021 and will produce the vaccine in the U.S., Europe, South Africa and India.
Read the press release
