“Independent research” is being commissioned to monitor possible coronavirus vaccines before 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 a vaccine, which scientists are racing to find in a bid to halt the deadly coronavirus pandemic.
“To authorise any COVID-19 vaccine, EMA will need to have strong evidence from clinical trials on the safety, efficacy and the quality of this vaccine,” the agency said in a statement.
“Once on the market, approved vaccines will 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 a vaccine.
Researchers will be responsible for providing “additional information from clinical practice” before the authorisation of vaccines through 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-19 vaccines in 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 a vaccine against the new coronavirus could be ready within a year in an “optimistic” scenario.