AMSTERDAM (Reuters) – The European Medicines Authority (EMA) is unlikely to be able to approve the COVID-19 vaccine developed by drugmaker AstraZeneca and Oxford University in January, said Deputy Chief Executive Officer Noel Wathion.
“They didn’t even apply to us,” Wathion said in an interview with Belgian newspaper Het Nieuwsblad on Tuesday.
European regulators have received only some information about the vaccine, Wathion said.
“Not even enough to guarantee a conditional marketing license,” he said. “We need additional data on the quality of the vaccine. And after that, the company must submit an official application. “
This made it “unlikely” that an approval could be granted as early as next month, Wathion said.
EMA could not be reached for comment.
AstraZeneca told Reuters last week that its COVID-19 vaccine should be effective against the new coronavirus variant, adding that studies are investigating the impact of the mutation.
He sent a complete package of data on his vaccine to the British drug regulator, said British Health Minister Matt Hancock.
Reporting by Bart Meijer; Mountain ranges of Giles Elgood