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

FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

(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.

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)

Article type: metered
User Type: anonymous web
User Status:
Campaign ID: 18
Cxense type: free
User access status: 3

Did you find this article insightful?


Next In World

Need a lift? SpaceX launches record spacecraft in cosmic rideshare program
Roundup: Problems hamper COVID-19 vaccination in U.S. southern states
Israel reports 3,155 new COVID-19 cases, 596,733 in total
Israel bans flights to prevent spread of new COVID-19 variants
Roundup: Egypt starts vaccinating medics with Sinopharm COVID-19 vaccine
1st LD: China largest FDI recipient in 2020 amidst global plunge -- UNCTAD report
Dozens of suspected Ethiopian extremists arrested: report
Urgent: China becomes largest FDI recipient in 2020 -- UNCTAD report
Morocco reports 520 COVID-19 cases, 466,289 in total
Sweden bans entry from Norway over new coronavirus variant

Stories You'll Enjoy