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HEALTH

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 opens Covid booster jab bookings from Monday

Regional health services in Italy will open bookings for Covid-19 booster shots to priority groups from Monday as the first deliveries of updated vaccines arrived in the country.

Italy opens Covid booster jab bookings from Monday

“From Monday, September 12th, bookings for the new dual-strain vaccines can begin at the regional level,” said director general of the Italian Medicines Agency (Aifa), Nicola Magrini, at a health ministry press conference on Friday.

Booster shots will not be mandatory and will be offered to priority groups first, health authorities confirmed.

READ ALSO: Italy gives green light to new dual-strain Covid vaccines

“The arrival of the new vaccines should strengthen the conviction of those who have to take the fourth dose because of their age or because they have other conditions,” Magrini said. 

Aifa on Monday approved the Comirnaty (Pfizer) and Spikevax (Moderna) dual-strain vaccines, which are effective against both the original strain and the more recent Omicron variants.

Italy will receive 19 million doses of the new vaccines in September, said Franco Locatelli, president of Italy’s Higher Health Council (ISS), at the press conference. 

The updated vaccines have been shown to “generate an antibody response against the Omicron Ba4 and 5 variants, which are the prevalent ones,” he said.

They represent “96 percent of all strains isolated in Italy so far”, he said.

Italian healthcare workers preparing doses of Covid vaccine.

The new dual-strain vaccines will be offered first to at-risk patients, including people aged over 60 and care home residents. Photo by Marco BERTORELLO / AFP

Covid vaccines “have been a triumph of science and medicine” and “have saved millions of lives”, Locatelli added.

Booster jabs are currently recommended for those in higher-risk categories as Italy begins its autumn vaccination campaign.

Priority will be given to those who are still waiting to receive a second booster dose (the so-called fourth dose); therefore over-60s and people with health conditions that make them more susceptible to developing more severe forms of the Covid-19 disease, according to the latest memo from the health ministry.

READ ALSO: What is Italy’s Covid vaccination plan this autumn?

Magrini said the priority list also includes “health workers, pregnant women, and residents of facilities for the elderly”.

But “it can also be administered to those under 60 who ask for it,” he added.

Booster shots can only be administered to those who received their last dose at least 120 days (about four months) earlier.

The vaccination campaign is expected to be expanded to all over-12s who have only completed the initial vaccination cycle. For this category, the new booster shot would be their third dose.

How do you book a booster shot?

As in previous vaccination campaigns, each regional health authority will manage their own local vaccination programmes, including their timing.

Bookings should work in much the same way as before, with patients being able to book their appointments through GPs, pharmacies or their ASL’s website where available.

Shots can be administered by family doctors as well as at designated vaccination hubs in more densely populated areas.

The autonomous province of Trentino said it will begin administering jabs immediately from Monday and will allow residents to begin booking jabs from Saturday, September 10th.

Other regions and autonomous provinces are expected to announce their plans in the coming days.

For further information on availability and reservation in your region, see the official vaccination booking website.

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