The European Commission has scored a conditional marketing authorisation for Johnson and Johnson’s single-dose COVID-19 vaccine.
Based on the submission of top-line efficacy and safety data from the Phase III ENSEMBLE trial, Johnson and Johnson submitted its vaccine for a CMA in the EU back in February.
“The European Commission has granted authorisation for Johnson and Johnson’s single-dose COVID-19 vaccine.“
The ENSEMBLE study found that twenty-eight days after vaccination, across all participants from different geographies, the vaccine was sixty-six per cent effective in preventing moderate-to-severe COVID-19. Furthermore, it was shown that the vaccine was 85% effective in preventing severe disease in all areas.
Chairman and chief executive officer, J&J, Alex Gorsky, stated: “For more than a year, we have been working around the clock, leveraging the scientific minds, scale and resources of our global organisation to bring forward a COVID-19 vaccine."