Canada Approves Johnson & Johnson COVID-19 Vaccine

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada had 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% effective in preventing severe disease.

And the Janssen vaccine 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, in a press statement.

“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.”

The Janssen COVID-19 Vaccine (Ad26.COV2.S, recombinant) is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals 18 years of age and older.

The Janssen COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale, and advertising of drugs for use in relation to COVID-19.

On November 23, 2021, the Janssen COVID-19 vaccine transitioned to an authorization under the Food and Drug Regulations.

Learn more at www.janssen.com/canada.