The decision to ban a particular batch of the AstraZeneca vaccine in Italy was made by the Italy Pharmaceutical Agency (AIFA), which reported that problems were found in a supply of 1 million doses that had been distributed across 17 countries in the EU.
“Although a quality defect is considered unlikely at the moment, the quality specifications of the lot are being investigated,” the AIFA said in a statement, adding the specific batch (ABV5300) had not been distributed in Italy.
The batch has already been shipped out to Austria, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Spain and Sweden.
Norway’s Institute of Public Health made a similar move on Thursday by temporarily suspending the AstraZeneca rollout. The agency’s Director of Infection Prevention and Control, Geir Bukholm, told a press conference: “This is a cautionary decision.”
“I would like to point out that the break does not mean that we do not recommend vaccination with AstraZeneca in the future,” he added.
Italian authorities said the safety committee of the European Medicines Agency (EMA) is reviewing the cases reported in connection with that particular batch as well as all other cases of thromboembolic events or blood clotting-related conditions reported after vaccination.
“The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that observed in the general population,” AIFA said, adding that 22 cases of thromboembolic events had been reported among 3 million people vaccinated with the AstraZeneca vaccine in the European Economic Area.