LONDON (Reuters) – AstraZeneca mentioned it has submitted full information to pursue conditional advertising and marketing authorisation from the European Medicines Company for its COVID-19 vaccine, however the regulator mentioned it nonetheless wants extra data for approval.
An EMA official mentioned earlier within the week that extra information was wanted and that AstraZeneca had not given sufficient element to warrant a conditional advertising and marketing licence for the shot it has developed with Oxford College.
“We are able to affirm that we’ve submitted a full information package deal to assist an utility for conditional advertising and marketing authorisation for the AstraZeneca COVID-19 vaccine to the European Medicines Company,” an AstraZeneca spokesman mentioned.
“AstraZeneca has been submitting information on a rolling foundation and can proceed to work carefully with the EMA to assist the beginning of a proper CMA utility course of.”
However the EMA mentioned that it nonetheless didn’t have sufficient data to evaluate the shot, which was permitted for emergency use in Britain on Wednesday.
“The most recent medical package deal was acquired on 21 December and is presently being assessed,” the EMA mentioned in an announcement.
“Extra scientific data on points associated to high quality, security and efficacy of the vaccine is deemed essential to assist the rigour required for a conditional advertising and marketing authorisation and this has been requested from the corporate.”