The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.

This decision was based on scientific evidence, including initial data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. 

"We are delighted by Health Canada's decision to approve the Johnson & Johnson COVID-19 vaccine based on Phase 3 clinical data that proves the vaccine's robust safety and efficacy," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "As vaccination rates continue to climb, a vaccine that prevents severe disease and protects against COVID-related hospitalization and death will help ease the strain on healthcare systems and is an important option for people in Canada and around the world."

"Today marks the first major regulatory approval for the Johnson & Johnson COVID-19 vaccine and an important moment to recognize the dedication of everyone involved in our COVID-19 vaccine development, our partners, the regulators and clinical study participants. We are proud to have a COVID-19 vaccine available to protect people around the world and will continue to work to ensure global access," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer and Johnson & Johnson.