EU watchdog could give emergency advice on COVID pill
Europe's drug watchdog said Thursday it could give countries advice on the emergency use of Merck's anti-COVID pill, as non-EU Britain became the first in the world to approve it.
The European Medicines Agency (EMA) said it would also try to accelerate the review that it launched last week on whether to formally green-light the drug for the EU, as a "fourth wave" of the disease looms.
"We will try to speed up our assessment in order to reach an authorisation as soon as possible," the EMA's head of vaccine strategy Marco Cavaleri told a news conference, adding that he could not yet give a timeline.
"We are also ready to give advice to European Union member states so that they could make this new oral antiviral available for emergency use, ahead of the authorisation."
The Amsterdam-based regulator had no powers to make a central ruling on emergency use for the whole of the EU and so could only give advice for individual states, said Cavaleri.
"Because we are entering and we are already in the fourth wave of this pandemic, we will be considering whether a scientific opinion from the EMA could support emergency use authorisation at the level of each member state," he added.
Britain's drug regulator said earlier Thursday it was approving the Merck drug, which slows down the disease in people who already have it, as opposed to vaccines which prevent people catching it in the first place.
The EMA meanwhile urged people to get vaccinated as soon as possible to curb the spike in coronavirus cases.
Its warning came as Germany reported a record daily rise in cases and the World Health Organization said that the surge in Europe was of "grave concern".
"The epidemiological situation in Europe is very concerning now," said Fergus Sweeney, the EMA's head of clinical studies and manufacturing task force.
"It's really important that we're all vaccinated, because we are not all protected until everyone is protected."
© 2021 AFP
