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VACCINE

Covid-19: Italy bans batch of AstraZeneca vaccine

Italy's medicines regulator said on Thursday it was banning a batch of the AstraZeneca/Oxford Covid vaccine as a precaution, amid fears of a link to blood clots that sparked suspensions elsewhere in Europe.

Covid-19: Italy bans batch of AstraZeneca vaccine
Photo: Miguel Medina/AFP

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.”

READ ALSO: Italy considers giving single dose of vaccine to people who have had Covid-19

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.

Covid vaccine
The AstraZeneca/Oxford Covid vaccine. Photo: Tiziana FABI/AFP

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.

READ ALSO:

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”.

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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COVID-19

Covid-19: Are Italian live events at risk of being postponed?

As the infection rate rises sharply across the country, Italian virologists are calling for concerts and festivals to be rescheduled.

Covid-19: Are Italian live events at risk of being postponed?

Italy has seen a large increase in the number of Covid-19 cases in recent days, so much so that a number of virologists across the country are now urging the government to postpone major live events in a bid to curb infections. 

According to a new report by Italy’s independent health watchdog, the Gimbe Foundation, 595,349 new cases were recorded in the week from June 29th to July 5th; a worrying 55 percent increase on the previous week. 

In the same time span, the country also registered a 32.8 percent rise in the number of hospitalised patients, which went from 6,035 to 8,003.  

The latest Covid wave, which is being driven by the highly contagious Omicron 5 variant, is a “real cause for concern”, especially in terms of a “potential patient overload”, said Nino Cartabellotta, president of the Gimbe Foundation. 

As Italian cities prepare to host a packed calendar of concerts and festivals this summer, health experts are questioning whether such events should actually take place given the high risk of transmission associated with mass gatherings.

READ ALSO: What tourists in Italy need to know if they get Covid-19

“Rescheduling these types of events would be the best thing to do right now,” said Massimo Ciccozzi, Director of Epidemiology at Campus Bio-Medico University of Rome. 

The summer wave is expected to peak in mid-July but, Ciccozzi warns, the upcoming live events might “delay [the peak] until the end of July or even beyond” and extend the infection curve.

Antonello Maruotti, Professor of Statistics at LUMSA University of Rome, recently shared Ciccozzi’s concerns, saying that live events as big as Maneskin’s scheduled Rome concert are “definitely not a good idea”. 

The Italian rock band are slated to perform at the Circus Maximus on Saturday, July 9th but the expected turnout – over 70,000 fans are set to attend the event – has raised objections from an array of Italian doctors, with some warning that the concert might cause as many as 20,000 new cases.

If it were to materialise, the prospected scenario would significantly aggravate Lazio’s present medical predicament as there are currently over 186,000 Covid cases in the region (nearly 800 patients are receiving treatment in local hospitals). 

Italian rock band Maneskin performing in Turin

Italian rock band Maneskin are expected to perform at the Circus Maximus in Rome on Saturday, July 9th. Photo by Marco BERTORELLO / AFP

But, despite pleas to postpone the event, it is likely that Maneskin’s concert will take place as scheduled.

Alessandro Onorato, Rome’s Tourism Councillor, said that rescheduling is “out of question” and that “all recommendations from the local medical authorities will be adopted” with the help of the event’s organisers and staff on the ground.

At the time of writing, there is also no indication that the Italian government will consider postponing other major live events scheduled to take place in the coming weeks, though the situation is evolving rapidly and a U-turn on previous dispositions can’t be ruled out.

READ ALSO: At a glance: What are the Covid-19 rules in Italy now?

On this note, it is worth mentioning that Italy has now scrapped all of its former Covid measures except the requirement to wear FFP2 face masks on public transport (though not on planes) and in healthcare settings.

The use of face coverings is, however, still recommended in all crowded areas, including outdoors – exactly the point that leading Italian doctors are stressing in the hope that live events will not lead to large-scale infection.

Antonio Magi, President of Rome’s OMCEO (College of Doctors, Surgeons and Dentists), said: “Our advice is to wear FFP2 masks […] in high-risk situations.”

“I hope that young people will heed our recommendations and think about the health risks that their parents or grandparents might be exposed to after the event [they attend].”

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