Johnson & Johnson requests EU approval for COVID-19 vaccine
European drug regulator says authorization for the single-dose vaccine could be granted by mid-March if its ‘efficacy, safety and quality are sufficiently comprehensive and robust’
THE HAGUE, Netherlands — Pharmaceutical giant Johnson & Johnson has applied for authorization for its 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 vaccine to be approved for use across the 27-nation European Union if it gets the green light from the Amsterdam-based European Medicines Agency.
“EMA has received an application for conditional marketing authorization for a COVID-19 vaccine developed by Janssen-Cilag International NV,” 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 authorized 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 also asked US regulators for emergency authorization in the United States.
The Times of Israel Community.