Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission

NEW BRUNSWICK, N.J., March 11, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Commission (EC) has granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older. The CMA follows a Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).2 The CMA is valid in all 27 member states of the European Union (EU), plus Norway, Iceland and Liechtenstein.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.2 The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.1 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 hospitalisation and death, beginning 28 days after vaccination.1 “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,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news