Covid-19: Johnson & Johnson files for EU vaccine approval

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J&J has applied to the EU for vaccine approval.
J&J has applied to the EU for vaccine approval.
Tharaka Basnayaka/NurPhoto via Getty Images

Pharmaceutical giant Johnson & Johnson has applied for authorisation for their coronavirus vaccine in the EU with a decision possible by the middle of March, Europe's drugs regulator said Tuesday.

The single-shot vaccine would be the fourth jab to be approved for use across the 27-nation European Union if it gets the green light from the Amsterdam-based European Medicines Agency.

Europe's drugs regulator said on Tuesday it could issue an opinion by mid-March on whether to approve J&J's vaccine under a speedy review.

"EMA has received an application for conditional marketing authorisation for a Covid-19 vaccine developed by Janssen-Cilag International N.V.," the watchdog said, referring to J&J's European subsidiary.

Experts at the regulator "could issue an opinion by the middle of March 2021, provided the company's data on the vaccine's efficacy, safety and quality are sufficiently comprehensive and robust."

J&J's vaccine has been under a "rolling review" by the EMA since December 1.

The other three vaccines currently authorised for use across the EU's member states are those developed by AstraZeneca, Pfizer/BioNTech and Moderna.

The European Commission has ordered 200 million doses of the Johnson & Johnson vaccine with an option for 200 more. It says 100 million doses should be delivered by June if it is approved.

Johnson & Johnson has asked US regulators for emergency authorisation for the United States.

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