The European Medicines Agency (EMA) will soon begin an accelerated evaluation of the potential corona vaccine being developed by the University of Oxford and pharmaceutical company AstraZeneca, and an insider told Bloomberg news agency.
The so-called Oxford vaccine would be the first to qualify for an evaluation procedure in the European Union.
The EMA expects to announce the ‘rolling review’, as the accelerated evaluation is called, this week, and the source says that does not want to be mentioned because the information is still confidential.
Such an evaluation procedure is used in an emergency so that the watchdog can see trial data while the trials are in progress, and an agent can be approved earlier. Remdesivir, a treatment agent for Covid-19, was also subjected to such an evaluation procedure.
The announcement would be a significant step forward for the Oxford vaccine after trials were halted earlier in September because a subject in the UK became ill.
While the UK watchdog allowed trials of the Oxford vaccine in the UK to resume after a week, as well as restarting experiments in South Africa, Brazil and India, US authorities have yet to give the green light to a resumption.
The British news agency Reuters reported Wednesday evening that the American medicine watchdog FDA had expanded the investigation into the case that led to the halting of the trials with the Oxford vaccine.
Marco Cavaleri, chief of vaccines at the EMA, said in July that the agency would begin accelerated evaluations of potential corona vaccines after the summer.
In this way, final approval of a vaccine can be granted within days of the end of the trials. Cavaleri said at the time that the first vaccine approval could be given by the end of this year.
AstraZeneca and the EMA declined to comment. “The EMA has always stated that it will communicate the start of an accelerated evaluation of Covid-19 treatments or vaccines,” the drug watchdog said in a statement. “We have not yet made such an announcement for a vaccine.”
English