Covid-19: EMA recommends conditional approval for Janssen vaccine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that the single-dose SARS.CoV.2 vaccine developed by Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) be conditionally licensed (CMA) for persons 18 years of age and older.
Data from the Phase 3 ENSEMBLE trial showed that the vaccine was well tolerated. Compared with study participants who received the placebo, symptomatic covid 19 disease was reduced by 67 percent in participants who received the vaccine. The onset of protection was observed from day 14 and was maintained for 28 days after vaccination. The data also showed that Janssen’s vaccine had 85 percent efficacy in preventing severe Covid-19-related disease progression and protection against Covid-19-related hospitalizations and deaths in all regions studied, beginning 28 days after vaccination.