Therapy Areas: Vaccines
EU's EMA expects first application for marketing approval of COVID-19 vaccine within days
26 November 2020 -

The European Medicines Agency (EMA), Europe's drugs watchdog, said on 26 November 220 that it expects to receive the first application for conditional marketing approval for a COVID-19 vaccine "in the coming days", Reuters news agency reported on Thursday.

The 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.

These companies had applied on 20 November 2020 for US approval and the UK said it has asked its medical regulator to assess the vaccine for its suitability.

When asked about its co-operation with the US Food and Drug Administration (FDA), the EMA said in an email the agency may not be able to synchronise the decision making process with other international regulators.

Reportedly, the EMA started a real-time review of the Pfizer-BioNTech vaccine on 6 October 2020 to speed up the process of approving a successful vaccine in the EU bloc, by allowing researchers to submit findings in real time, without waiting for studies to conclude.