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Italy to review use of AstraZeneca Covid vaccine on under-50s

Italy's top panel of health experts is preparing to issue new advice on whether the AstraZeneca vaccine should be given to under-50s, after several Italian regions launched vaccination drives to offer unused doses to young adults.

Italy to review use of AstraZeneca Covid vaccine on under-50s
Empty vials of the AstraZeneca vaccine. Photo: GABRIEL BOUYS / AFP

The CTS, the scientific committee that advises the Italian government on health policy, is expected to announce its decision shortly.

It comes as health authorities announced that an 18-year-old in north-west Italy who was vaccinated with AstraZeneca two weeks ago had died after developing a blood clot.

AstraZeneca remains approved for adults of all ages in Italy, though the Italian Health Ministry recommends “preferential use in people over the age of 60” due to a small number of cases worldwide of unusual blood clots in younger people who had recently received the vaccine.

READ ALSO: Which Italian regions are offering Covid vaccine appointments to over-12s?

Yet a number of Italian regions have been offering the Covid-19 vaccine to younger adults as part of vaccination “open days”: special vaccination drives, often at evenings or weekends, that allow the youngest age groups to get a shot earlier than they otherwise might.

In most cases the doses available are AstraZeneca, also known as Vaxzevria. Several regions have found themselves with unused doses of the Oxford University vaccine, as people opt to get vaccinated with alternatives that they perceive as safer or that have a shorter interval between doses (or in the case of Johnson & Johnson, require just one shot). 

The CTS gave the green light to AstraZeneca “open days” in May, when it said it did not object to regions offering the vaccine to over-18s on a voluntary basis.

But now the committee is reviewing whether to limit AstraZeneca to over-30s or even over-40s only, undersecretary for health Pierpaolo Sileri told the press. “We won’t revise it for over-50s, because the risk-benefit ratio is without a doubt in favour of the benefits,” he said.

In recent days several Italian health experts have called on the government to restrict the use of AstraZeneca on younger adults out of caution.

Health think tank the GIMBE Foundation argued that both AstraZeneca and Johnson & Johnson vaccines should be reserved for over-50s, on the grounds that younger adults in Italy are currently at very low risk of falling seriously ill with Covid-19 and the vaccines’ risk-benefit ratio for this age group is therefore different.

GIMBE has called for younger people to receive either the Pfizer or Moderna vaccine, which work differently from the AstraZeneca or Johnson & Johnson vaccines and have not been associated with the same side effects.

To date, most of the rare cases of blood clots observed after vaccination with AstraZeneca or Johnson & Johnson have been reported in younger adults, prompting some EU countries to restrict their use to older age groups.

The European Medicines Agency (EMA) says it is not yet clear what the risk factors are, and that the benefits of the AstraZeneca vaccine continue to outweigh the very low chance of side effects.

EXPLAINED: Why has Italy recommended the AstraZeneca vaccine for over-60s only?

One planned vaccination drive in Naples has already been cancelled in anticipation of the CTS’s decision, while other regional health services have chosen to offer only Pfizer or Moderna vaccines to people aged between 12 and 59.

There was also alarm after two young women, one aged 18 and another 34, were admitted to intensive care in Genoa this week with blood clots, around a fortnight after receiving a first dose of AstraZeneca from the same batch. 

The younger woman died on June 10th, local authorities announced.

The regional health authority has withdrawn the batch in question throughout Liguria as a precautionary measure, it said on Thursday.

AstraZeneca vaccination drives remain underway or scheduled in several parts of Italy, including Lazio, the region around Rome, which is currently running an AstraZeneca “open week” for over-18s until June 13th. 

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Around a third of all doses of AstraZeneca and Johnson & Johnson administered in Italy in the past three weeks – more than 470,000 – went to under-50s, according to GIMBE.

It is not clear what new restrictions would mean for under-50s who have already received one dose of AstraZeneca. Italy’s drug regulator AIFA currently recommends that people get both doses of the same vaccine.

Most of the side effects observed so far occurred within two weeks of the first dose. The second dose is thought to carry an even lower risk, though more data is needed to know for sure.

Data from millions of people vaccinated with AstraZeneca across Europe and the UK indicates that serious side effects after either dose remain extremely rare.

In a monitoring report released this week, AIFA said that in Italy the incidence of blood clots after vaccination was around one per 100,000 injections of AstraZeneca, mainly in people under 60. It has not received reports of any clots developing after the second dose, the agency said.

“All vaccines are safe,” Health Minister Roberto Speranza told parliament on Thursday, while confirming that the CTS was reviewing its advice on the use of AstraZeneca in young people.

What symptoms should people watch out for?

The EMA advises seeking medical help immediately if you notice any of these symptoms after getting vaccinated:

  • shortness of breath
  • chest pain
  • swelling in your leg
  • persistent abdominal pain
  • neurological symptoms, including severe and persistent headaches or blurred vision
  • tiny blood spots under the skin beyond the site of injection

Early medical treatment can prevent complications and help lead to recovery, the agency says.

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COVID-19 VACCINES

Italy approves fourth Covid vaccine doses for over-60s

Italy has extended the availability of a second Covid-19 vaccine booster shot as infection rates surge across the country.

Italy approves fourth Covid vaccine doses for over-60s

The Italian health ministry announced that fourth Covid vaccine doses, or second booster shots, will soon be available to all residents aged 60 and over, as national medicines regulator Aifa gave the green light on Monday.

Health minister Roberto Speranza said on Monday that doses could be administered to this age group “immediately”, as Italy “moves in line” with recommendations from the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC).

“In the coming hours, immediately, already today, we will adapt our guidelines, our circulars and our indications. We will immediately open up administration in our regions.

“We mustn’t think that the battle against Covid is won. It is still ongoing and we must keep the level of caution high,” he said.

The health ministry confirmed in an update on its website that second booster doses were now recommended to “all persons aged 60 years or older, provided there has been an interval of at least 120 days since the first booster dose or the last post-booster infection (date of positive diagnostic test)”.

READ ALSO: Fourth jabs and isolation: Italy’s plan to control Covid cases this summer

The availability of fourth doses will vary by region, as each local health authority is responsible for managing the timing of its own vaccination campaign.

Several regions, including Lazio (around Rome) and Lombardy (around Milan), said on Monday that they would allow over-60s to book their fourth jabs within the coming days.

A fourth dose can be booked as usual, via pharmacies or family doctors, and via regional booking websites where available. (Find more information in a separate article here.)

Speranza didn’t say when second booster shots may be rolled out to all age groups, stating only that “a new vaccination campaign” is set to begin in September.

Health authorities have previously said they are not planning to make a fourth dose mandatory, though an annual “top-up” shot is likely to be offered.

Until now, only over-80s, care home residents, and clinically vulnerable patients have been eligible for a fourth shot in Italy.

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

But health experts are also urging the government to speed up the administration of fourth jabs to these vulnerable groups: uptake remains far lower than hoped so far, with 78 percent of over-80s not getting theirs yet.

With the coronavirus infection rate now at its highest level since February, and the number of hospitalisations expected to keep rising in the coming weeks, the health ministry has not said whether it plans to bring back any recently-scrapped health measures.

For now, the government’s strategy appears to be focused on maintaining the relatively high rate of vaccination coverage in Italy: 90 percent of the population over 12 years old has been fully vaccinated with at least two doses, official figures show.

Find out more about booking a booster shot in Italy in a separate article here. See the government’s ‘prenotazione vaccino‘ (vaccine booking) website for links to regional authorities’ appointment reservation platforms.

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