EU agency to set up 'independent' research on virus vaccine

EU agency to set up 'independent' research on virus vaccine

Wednesday, May 27, 2020

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THE HAGUE,Netherlands (AFP)— "Independent research" is being commissioned to monitor possible coronavirusvaccinesbefore and after they hit the European market, the European Medicines Agency (EMA)said Wednesday.

The Amsterdam-based EU agency said its main focus would be on the safety and efficacy of avaccine, which scientists are racing to find in a bid to halt the deadly coronavirus pandemic.

"To authorise any COVID-19vaccine, EMA will need to have strong evidence from clinical trialson the safety,efficacyand the quality of thisvaccine," the agency said in a statement.

"Once on the market, approvedvaccineswill be monitored closely by the agency," it added.

The agency has contracted the University of Utrecht "to conduct preparatory research", including methods that can be used to control the use of avaccine.

Researchers will be responsible for providing "additional information from clinical practice" before the authorisation ofvaccinesthrough clinical trials and "post-authorisation through spontaneous reporting".

The EMA wants to "ensure that a European infrastructure will be in place to effectively monitor COVID-19vaccinesin the real world, once they are authorised in the European Union".

The first results of the research are scheduled for August, with final results expected by the end of the year, the agency said.

The EMA estimated in mid-May that avaccineagainst the new coronavirus could be ready within a year in an "optimistic" scenario.


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