Johnson & Johnson COVID vaccine wins full approval in Canada in first major regulatory nod


Johnson & Johnson JNJ, -0.28% said Wednesday its one-dose COVID-19 vaccine has been granted full approval by Health Canada, marking its first major regulatory approval. The vaccine has been granted an emergency use authorization in the U.S. So far, only the vaccine developed by Pfizer Inc. PFE, -0.37% and German partner BioNTech SE BNTX, -1.32% has gained full approval from the U.S. regulator, the Food and Drug Administration, in an August decision. A full approval allows the vaccine to be mandated by companies and institutions and experts were hopeful it would help persuade unvaccinated people that the vaccine is safe and effective. “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,” said Mathai Mammen, M.D., Ph.D., global head, Janssen Research & Development, Johnson & Johnson, in a statement. J&J shares were slightly lower premarket, but have gained 2% in the year to date, while the Dow Jones Industrial Average DJIA, -0.03% has gained 17% and the S&P 500 SPX, +0.23% has gained 25%.

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