The coordinator of the national vaccination campaign, Valeriu Gheorghita, said on Tuesday that he does not expect the withdrawal of the marketing authorisation for the AstraZeneca vaccine, but said that "additional recommendations" will most likely be issued.
Asked if he was considering the statement by the head of vaccination strategies at the European Medicines Agency (EMA) that there was a link between thrombosis and the AstraZeneca vaccine and if there was a "scenario" in which this serum would not be used, the military doctor replied: "We are also informed about the statement of the EMA official. I would just like to mention that the meeting of the Pharmacovigilance Committee, which is taking place right now, is not yet finalized. Following this meeting, clear EMA recommendations will be transmitted," Gheorghita told a press conference, agerpres.ro confirms.
He said he expected particular recommendations to be made "for a particular person profile."
"We expect particular recommendations to be made, perhaps for a certain profile of a person, who may be at risk of developing these types of events, thrombotic, particular ones. We must also mention that this mechanism for assessing all adverse reactions is valid for all medicines and vaccines, it is a common process and it is very good that this is the case and that we have these signals, just to avoid unanalyzed and uninvestigated things. We do not expect a withdrawal of the marketing authorization for this vaccine. It is very likely that there will be additional recommendations sent and the recommendations in the product characteristics will be modified, practically changes in the leaflet", the doctor explained.