AMSTERDAM (Reuters) – The European Medicines Authority (EMA) is unlikely to be able to approve the COVID-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January, said watchdog deputy executive director Noel Wathion.
“They haven’t even filed an application with us yet,” Wathion said in an interview with the Belgian newspaper Het Nieuwsblad published on Tuesday.
European regulators have only received some information about the vaccine, said Wathion.
“Not even enough to secure a conditional marketing license,” he said. “We need additional data on the quality of the vaccine. And after that, the company has to formally apply. “
That made it “unlikely” that an approval could already be granted next month, said Wathion.
The EMA could not be reached for comment.
AstraZeneca told Reuters last week that its vaccine COVID-19 must be effective against the new coronavirus variant, adding that studies are underway to fully investigate the impact of the mutation.
He sent a complete package of data about his vaccine to the British drug regulator, said British Health Minister Matt Hancock.
Reporting by Bart Meijer; Editing by Giles Elgood