The Italian Medicines Agency (AIFA) stated in a press release on Thursday that it had banned the use of batch number ABV2856 of the vaccine in Italy following the reporting of some “serious adverse events”.
But the regulator said there was currently no established link between the vaccine and the alleged side-effects – a position reinforced by Italian Prime Minister Mario Draghi’s office.
Following the announcement, a spokesman for 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”.
AIFA stressed in its statement that “at present, no causal link has been established between the administration of the vaccine and these events.”
It had “decided as a precaution to issue a ban on the use of this batch throughout the national territory. and reserves the right to take further measures, where necessary.”
The agency said it was “carrying out all the necessary checks,” working “in close coordination with the EMA, the European pharmaceutical agency.”
The batch mentioned by the Italian regulator, batch ABV2856, is different to that suspended by Austria on Monday, which was named by the EMA as batch ABV5300.
AIFA had said in a previous statement that ABV5300 was not distributed in Italy.
It was not immediately clear why the other batch had been banned, or if that was the only AstraZeneca batch being used in Italy currently.
Austria announced on Monday it had suspended the use of the particular AstraZeneca batch, after a 49-year-old nurse died of severe blood coagulation days after receiving the shot.
On Wednesday, the EMA said a preliminary investigation showed that the batch of AstraZeneca vaccines used in Austria was likely not to blame for the nurse’s death.
Estonia, Latvia, Lithuania and Luxembourg have also suspended the use of the particular batch, which was sent to 17 European countries and consisted of one million jabs.
Denmark, Norway and Iceland on Thursday went further, suspending the use of AstraZeneca’s Covid-19 vaccine.
- Denmark suspends use of AstraZeneca vaccine
- AstraZeneca vaccine ‘not to blame for Austrian nurse’s death’
Danish health authorities said on Thursday the suspension was a precaution, after some patients developed blood clots since receiving the jab, one of whom died.
The Danish Health Authority said that “it has not been determined, at the time being, that there is a link between the vaccine and the blood clots”.
An AstraZeneca spokesperson said the vaccine had been “extensively studied in Phase III clinical trials”, adding that “peer-reviewed data confirms the vaccine has been generally well tolerated”.
AstraZeneca’s coronavirus vaccine was this week approved for use in Italy on over-65s.
Find all of The Local’s latest updates on the coronavirus situation in Italy here.