Rome: Italy’s medicines regulator on Thursday banned the use of a batch of AstraZeneca/Oxford coronavirus vaccine as a precaution, triggering a similar decision from fellow EU member Romania.
The Italian regulator made the decision despite saying there was no established link between the vaccine and reports of some people suffering blood clots days after receiving the shot.
“Following the reporting of some serious adverse events AIFA has decided, as a precaution, to issue a ban on the use of this batch throughout the national territory,” the AIFA regulator said in a statement.
A spokesman for Italian Prime Minister Mario Draghi said that, in a phone call with European Commission chief Ursula Von Der Leyen, “it emerged that there is no evidence of a link between the cases of thrombosis in Europe and the administration of the AstraZeneca vaccine”.
“President Von Der Leyen reported that the European Medicines Agency had initiated a further accelerated review.”
the AIFA said it “reserves the right to take further measures, if necessary,” in coordination with the European Medicines Agency (EMA).
As a consequence of Italy’s decision, the Romanian government on Thursday evening said that it was withdrawing over 4,200 doses from the same AstraZeneca batch.
“We take this measure as an extreme precaution, without any scientific reason in Romania which led to this”, Romania’s national centre for vaccination against Covid-19 said in a press release.
However, Bucharest mentioned that the overall campaign with the AstraZeneca vaccine will go on as scheduled.
The batch mentioned by the Italian regulator, ABV2856, is different to that suspended by Austria on Monday, which the EMA named as ABV5300.
On Monday, Austria announced it had suspended the use of that particular AstraZeneca batch, after a 49-year-old nurse died of severe blood coagulation days after receiving the shot.
Other countries followed suit, while Denmark, Norway and Iceland on Thursday went further, suspending entirely the use of AstraZeneca’s vaccine.
The EMA said Thursday there had been 30 cases of ‘thromboembolic events’ among five million people who have had the jab so far in Europe.
However the EMA added there is no indication that the vaccine caused these conditions and that the AstraZeneca jab could continue to be used pending the results of a probe.