Cyprus Mail 26 November 2020 - by Reuters News Service
The European Medicines Agency (EMA) is “very hopeful” it will be able to give a positive scientific opinion on COVID-19 vaccines seeking regulatory approval before Christmas, the regulator’s new chief said on Wednesday.
“All going well we would be very hopeful that we could have a positive opinion before Christmas,” EMA Executive Director Emer Cooke told RTE radio in an interview.
British drugmaker AstraZeneca followed U.S. rivals Pfizer and Moderna on Monday in publishing successful pivotal trial data for its COVID-19 vaccine, giving the world’s fight against the pandemic a third new weapon.
Cooke was quoted on Tuesday by the Irish Independent as saying the EMA’s aim was to reach a positive recommendation on a similar timeline to the U.S. Food and Drug Administration (FDA), which is expected to have a verdict in mid-December on Pfizer’s proposed vaccine.
“What we hear at the moment is the results coming out of the clinical trials and these are very positive. But until we look at the raw data and make sure that it is what is says on the box, we can’t recommend it for the European public,” she said.
“Let me say that 90 per cent effective is very, very good for a vaccine, so the possibility that this will be supported in practice by what we see in the dossier makes us look very optimistically at this,” Cooke said, when asked about data from all three companies.
The European Union has struck a deal for up to 160 million doses of U.S. firm Moderna’s COVID-19 vaccine candidate, the head of the European Commission said on Tuesday, taking the EU’s potential stock of COVID-19 shots to nearly 2 billion.
Actual purchases will be carried out by EU governments if the vaccine is approved by the EU’s drug regulator.
The doses would be enough to vaccinate 80 million people as the vaccine is expected to be administered in two doses.
