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 European Medicines Agency (EMA) did not name the company it expects to file the application, but Pfizer Inc and BioNTEch are the most advanced in the regulatory process among the three companies that have published late-stage trial data for their vaccines.
The companies applied on November 20th for US approval and the UK said it has asked its medical regulator to assess the vaccine for its suitability.
Asked about its cooperation with the US Food and Drug Administration (FDA), it said in an email the agency may not be able to synchronise the decision-making process with other international regulators.
Review
The EMA started a real-time review of the Pfizer-BioNTech vaccine on October 6th to speed up the process of approving a successful vaccine in the bloc, by allowing researchers to submit findings in real time, without waiting for studies to conclude.
It comes as Ireland has signed up for advanced purchase orders for more than 10 million doses of Covid-19 vaccines.
The Republic's Government is bidding for doses through the EU system and now has capacity on pre-order to comfortably provide enough vaccine for the entire country.
