European Medicines Agency

J&J likely to seek EU approval for Covid-19 vaccine in February, says lawmaker

US firm Johnson & Johnson is likely to apply for EU approval for its Covid-19 vaccine candidate in February, a top lawmaker said on Wednesday.

Clinical data of the vaccine, which Johnson & Johnson is developing through its subsidiary Janssen, have been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval.

EU may soon approve new use of Pfizer vaccine increasing doses by 20%, says source

The European drugs regulator could soon give the go ahead for an extra sixth dose to be extracted from Pfizer-BioNTech Covid-19 vaccine vials, an EU official told Reuters on Wednesday, lifting the number of available shots at a time when supplies are short.

EU regulator gives conditional approval to COVID-19 vaccine

The European Medicines Agency says an expert committee has recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union, weeks after the shot was first granted permission under emergency provisions in Britain and the United States.

Explainer: Why is the EU taking so long to OK vaccine?

As Canadians, Britons and Americans begin getting immunized with a German-developed vaccine against coronavirus, pressure is building on the European Medicines Agency to approve the shot made by Pfizer Inc. and the German company BioNTech.

German officials have been especially vocal that they want it approved before Christmas. Here's a look at the EMA approval process:


First Covid vaccinations in EU likely this year, EU Commission head says

European Union countries could begin coronavirus inoculations as soon as this year, the head of the European Commission said on Tuesday.

This followed the EU drug regulator's decision to bring forward its possible approval of the Pfizer/BioNTech coronavirus vaccine to Dec. 21.

Pressure mounts on EU drug regulator to approve Pfizer Covid-19 vaccine

Europe's drug regulator is under increasing pressure to quickly approve the Covid-19 vaccine developed by US giant Pfizer and Germany's BioNTech, officials said, as inoculations get started in Britain and the United States.

The push underscores the frictions between regulators and governments wishing to curb the pandemic that has killed more than 1.6 million people worldwide.