EU drugs regulator stands by its procedure as UK issues emergency approval of Covid-19 vaccine
The European Medicines Agency, the EU’s drug regulator, has defended its approach to evaluating potential Covid-19 vaccines, after the UK became the first country to approve the use of a vaccine based on large clinical trials.
On 2 December the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency, granted temporary authorisation—a form of emergency approval—for a vaccine designed and made by the German and US companies BioNTech and Pfizer, enabling it to be used in the country within days.
This kind of authorisation differs from that being considered by the EMA, the European regulator said. It is evaluating an application for a conditional marketing authorisation for the vaccine.
‘Supported by extensive data’
“EMA considers that the CMA is the most appropriate regulatory mechanism for use in the current pandemic emergency, to grant all EU citizens’ access to a vaccine and to underpin mass vaccination campaigns,” the EMA said.
“A CMA application is supported by extensive data submitted by companies to demonstrate the quality of a vaccine, how well it works and its safety. These are essential elements to ensure a high level of protection to citizens during the course of a mass vaccination campaign.”
The EMA said its form of approval might take “slightly longer” than the kind used by the UK, but that its process was being “expedited” and that the differences in timings “are not expected to affect significantly vaccines’ availability”.
‘Not a football competition’
Both forms of authorisation require a lower standard of evidence than normal marketing authorisation for drugs. They are offered with conditions, such as enhanced monitoring of the drug by regulators.
“This is not a football competition, we are talking about the life and the health of people,” an EU spokesman said on 3 December, responding to a media question on the UK’s earlier approval.