Canada Fully Approves J&J COVID-19 Vaccine for Adults

Boxes containing Janssen COVID-19 vials sit stacked in a refrigeration unit shortly after their delivery to Louisville Metro Health and Wellness headquarters in Louisville, Ky., on March 4, 2021. (Jon Cherry/Getty Images)

Johnson & Johnson announced Wednesday that Canada’s health agency has given full approval to its single-shot COVID-19 vaccine for people aged 18 years and above, making it the first to fully approve the vaccine globally.

Janssen Pharmaceuticals said in a statement on Wednesday that Health Canada has approved its vaccine, following a study that shows it to be 85 percent effective in preventing severe disease and protects against COVID-19 related hospitalization and death starting 28 days after the injection.

This marks the “first major regulatory approval” for its vaccine, said Paul Stoffels, vice chairman of the executive committee and chief scientific officer for Johnson and Johnson.

Mathai Mammen, global head for Janssen Research and Development, said he is “delighted” by Health Canada’s decision to approve the company’s vaccine.

“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,” Mammen said.

Health Canada had previously approved the use of the Johnson and Johnson COVID-19 vaccine under an interim order.

Last month, Canada also approved the Pfizer-BioNTech’s COVID-19 vaccine to be used in children aged 5 to 11, an age group that was previously ineligible for a vaccine. On Nov. 9, the country also authorized booster shots of the Pfizer vaccine for people aged 18 years and above.

In October, the U.S. Food and Drug Administration (FDA) also authorized booster shots of the Johnson and Johnson vaccine in the United States for all individuals aged 18 years and older, which may be administered at least 2 months after the first shot.

On Nov. 19, the FDA also authorized COVID-19 vaccine boosters from Pfizer-BioNTech and Moderna for all people aged 18 and older. Both the Pfizer and Moderna booster vaccines may be administered 6 months after the primary series of doses. Prior to that announcement, booster shots of both vaccines had been available in cases of certain high-risk profiles.