An EMA official said earlier in the week that more data was needed and that AstraZeneca had not given enough detail to warrant a conditional marketing licence.
AstraZeneca said it has submitted full data to pursue conditional marketing authorisation from the European Medicines Agency for its COVID-19 vaccine, but the regulator said it still needs more information for approval.
An EMA official said earlier in the week that more data was needed and that AstraZeneca had not given enough detail to warrant a conditional marketing licence for the shot it has developed with Oxford University.
“We can confirm that we have submitted a full data package to support an application for conditional marketing authorisation for the AstraZeneca COVID-19 vaccine to the European Medicines Agency,” an AstraZeneca spokesman said.
“AstraZeneca has been submitting data on a rolling basis and will continue to work closely with the EMA to support the start of a formal CMA application process.”
But the EMA said that it still did not have enough information to assess the shot, which was approved for emergency use in Britain on Wednesday.
“The latest clinical package was received on 21 December and is currently being assessed,” the EMA said in a statement.
“Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company.”