EMA, Health Canada start rolling review of J&J's COVID-19 vaccine candidate - Metro US

EMA, Health Canada start rolling review of J&J’s COVID-19 vaccine candidate

FILE PHOTO: Vials and medical syringe are seen in front of J&J logo in this illustration

(Reuters) – Johnson & Johnson said late Tuesday that health regulators in Europe and Canada had started a real-time review of its COVID-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.

The European Medicines Agency said the review would go on until enough evidence was available for a formal marketing authorisation application for the vaccine, which is being developed by the U.S. company’s Janssen unit.

“Janssen will continue to work with Health Canada to complete the rolling review process and to facilitate an approval when appropriate,” J&J said.

Rivals Moderna Inc and Pfizer-BioNTech also applied for emergency authorization on Tuesday to launch their vaccine candidates in Europe.

Canada’s Health Minister Patty Hajdu said in a tweet earlier in the day that J&J has submitted its vaccine candidate for a review by Health Canada, making it the fourth vaccine to begin the approval process in the country. (https://bit.ly/36r8fi9)

Canada had in August signed a deal with J&J for up to 38 million doses of its vaccine candidate. Rival vaccine candidates by Pfizer-BioNTech, Moderna and AstraZeneca are already under review by Health Canada.

(Reporting by Muvija M, Manojna Maddipatla and Bhargav Acharya in Bengaluru; Editing by Saumyadeb Chakrabarty, Arun Koyyur and Sherry Jacob-Phillips)

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