(Photo: The Canadian Press)

By Justin Goulet

Health Canada grants full approval to Johnson & Johnson’s COVID vaccine for people 18 and older

Nov 24, 2021 | 8:48 AM

OTTAWA, ON – Health Canada has approved the single-dose COVID-19 vaccine from Johnson & Johnson for individuals 18 years of age and older.

In a release, it was stated that the decision was based on scientific evidence, including initial data from the Phase 3 ENSEMBLE study that found the vaccine was 85 per cent effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death, starting 28 days after vaccination.

Mathai Mammen, M.D., Ph.D., Global Head of Janssen Research & Development, Johnson & Johnson said, “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.”

“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 Phase 3 trial was done in eight countries across three continents and included a wide range of individuals including 35 per cent of participants over the age of 60. 40 per cent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.

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