Canada has granted full approval for the single-dose Johnson & Johnson COVID-19 vaccine for adults 18 years and older, the pharmaceutical company announced Wednesday. Canada is the first country to fully authorize the Johnson & Johnson shot.
“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,” Johnson & Johnson’s vice chairman of the executive committee and chief scientific officer Paul Stoffels, M.D. said in a statement.
Health Canada granted the company’s vaccine full authorization after initial data from a clinical study showed that it was 85% effective in preventing severe disease, and, starting 28 days after vaccination, it provides protection against hospitalization and death due to COVID-19. The data also revealed that protection against COVID-19 increases when a booster shot of Johnson & Johnson’s vaccine is administered and that booster shots are safe and generally well-tolerated.
“Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective.” Health Canada writes on its vaccine webpage. “The benefits must also outweigh any risks.”
In March, Canada granted emergency use authorization for the Johnson & Johnson shot under an interim order. The vaccine then transitioned to an authorization under Canada’s Food and Drug Regulations before it received full authorization from Health Canada.
“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,” Johnson & Johnson’s Global Head Mathai Mammen M.D., Ph.D. said.
Health Canada has also authorized the AstraZeneca, Moderna, and Pfizer vaccines for all adults 18 years and older.