European Medicines Agency

The European Union unveiled Wednesday plans to revamp the 27-nation bloc's dated cybersecurity rules, just days after data on a new coronavirus vaccine was unlawfully accessed in a hack attack on the European Medicines Agency.

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:

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.

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.

Britain on Dec. 2 became the first country to approve Pfizer-BioNTech's COVID-19 vaccine for general use and said it would be introduced next week.    

Pfizer Inc and BioNTech's Covid-19 vaccine could be rolled out in Europe this month, the companies said on Tuesday after they applied for EU emergency approval for the shot.

Europe's drugs watchdog said on Thursday it expects to receive the first application for conditional marketing approval for a Covid-19 vaccine "in the coming days", the latest step towards making a shot available outside the United States.

The European Union's healthcare regulator said that no drug shortages or supply disruptions have been reported in the region but that an EU steering group had convened to prevent supply bottlenecks due to the coronavirus outbreak.

"As the public health emergency develops, shortages or disruptions cannot be excluded," the European Medicines Agency (EMA) said in a statement on Tuesday.

The sale of medicines containing ranitidine will be stopped in Bulgaria. This was reported by the Bulgarian Drug Agency (BDA).

Greece's National Organisation for Medicines (EOF) announced it is recalling yet two more lines of an over-the-counter heartburn medication containing the drug ranitidine, over fears that production lines have been contaminated with the potential carcinogen N-nitrosodimethylamine, or NDMA.