Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion

NEW BRUNSWICK, N.J., March 11, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion to recommend the Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older. Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.1 “The European Medicines Agency’s recommendation is a landmark moment for Johnson & Johnson and for the world,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news