Italy suspends use of AstraZeneca vaccine over blood clot concerns
Italy's medicines agency AIFA said on Monday it had joined other European nations in blocking the use of the AstraZeneca-Oxford vaccine over concerns about a possible link to blood clots.
"AIFA has decided to extend the ban on the use of AstraZeneca's Covid-19 vaccine throughout Italy as a precautionary and temporary measure pending European Medicines Agency (EMA) rulings," said the regulator, adding the decision was made in line with similar measures by other European countries.
READ ALSO: Which countries in Europe have suspended AstraZeneca vaccinations?
The decision came after talks between Health Minister Roberto Speranza and ministers in Germany, France and Spain.
"The choices made and shared today by the main European countries on AstraZeneca have been taken purely as a precautionary measure pending the next decisive meeting of the European Medicines Agency," Speranza said in a statement.
"We are confident that the European agency will already in the next few hours be able to definitively clarify this issue."
The news comes just days after AIFA blocked the use of one batch of the vaccines, despite stressing that there was no established link between the vaccine and the alleged side-effects.
Italy joins a growing list of countries suspending use of the vaccine on Monday, including France and Germany.
Ireland, Denmark, Norway and Bulgaria had previously suspended use of the AstraZeneca jabs.
The northern Italian region of Piedmont on Sunday said it had blocked use of the vaccine as investigations were carried out after the death of a teacher who had received it the day before.
The woman, who age has not been disclosed, died on Sunday in the town of Biella, north of Turin.
"This is an extreme precautionary measure, while waiting to see if a causal link exists between the vaccination and the death," said a statement from regional health advisor Luigi Genesio Icardi.
CHARTS: How many people has Italy vaccinated so far?
On Sunday, health ministry inspectors arrived in Sicily in the south of the country to investigate the death there of a 43-year-old soldier last Tuesday after having received the vaccine.
The World Health Organization, Europe’s medicines watchdog, governments and experts have stressed that no causal link has been established between the vaccine and blood clotting and insisted that the vaccine is safe.
AstraZeneca, an Anglo-Swedish company which developed the vaccine with Oxford University, has defended the safety of its product.
“Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” AstraZeneca’s chief medical officer Ann Taylor said in a statement.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” Taylor also said.
The Italian ban comes as the country is reviewing its vaccination programme, aiming to significantly speed up the vaccine roll-out between March and June.
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.
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"AIFA has decided to extend the ban on the use of AstraZeneca's Covid-19 vaccine throughout Italy as a precautionary and temporary measure pending European Medicines Agency (EMA) rulings," said the regulator, adding the decision was made in line with similar measures by other European countries.
READ ALSO: Which countries in Europe have suspended AstraZeneca vaccinations?
The decision came after talks between Health Minister Roberto Speranza and ministers in Germany, France and Spain.
"The choices made and shared today by the main European countries on AstraZeneca have been taken purely as a precautionary measure pending the next decisive meeting of the European Medicines Agency," Speranza said in a statement.
"We are confident that the European agency will already in the next few hours be able to definitively clarify this issue."
The news comes just days after AIFA blocked the use of one batch of the vaccines, despite stressing that there was no established link between the vaccine and the alleged side-effects.
Italy joins a growing list of countries suspending use of the vaccine on Monday, including France and Germany.
Ireland, Denmark, Norway and Bulgaria had previously suspended use of the AstraZeneca jabs.
The northern Italian region of Piedmont on Sunday said it had blocked use of the vaccine as investigations were carried out after the death of a teacher who had received it the day before.
The woman, who age has not been disclosed, died on Sunday in the town of Biella, north of Turin.
"This is an extreme precautionary measure, while waiting to see if a causal link exists between the vaccination and the death," said a statement from regional health advisor Luigi Genesio Icardi.
CHARTS: How many people has Italy vaccinated so far?
On Sunday, health ministry inspectors arrived in Sicily in the south of the country to investigate the death there of a 43-year-old soldier last Tuesday after having received the vaccine.
The World Health Organization, Europe’s medicines watchdog, governments and experts have stressed that no causal link has been established between the vaccine and blood clotting and insisted that the vaccine is safe.
AstraZeneca, an Anglo-Swedish company which developed the vaccine with Oxford University, has defended the safety of its product.
“Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” AstraZeneca’s chief medical officer Ann Taylor said in a statement.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” Taylor also said.
The Italian ban comes as the country is reviewing its vaccination programme, aiming to significantly speed up the vaccine roll-out between March and June.
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.
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