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COVID-19 VACCINES

EU approves first Covid jab for children aged 5 to 11

The EU's drug agency cleared Pfizer's Covid-19 vaccine for use in children aged five to 11 on Thursday, the first jab to be approved in a cohort where the virus is rapidly spreading.

A child, age 8, receives the Pfizer-BioNTech Covid-19 vaccine
A child, age 8, receives the Pfizer-BioNTech Covid-19 vaccine Andrej Ivanov / AFP

Only a small handful of countries had previously given the nod for coronavirus vaccinations in younger children, including the United States, Israel and Canada.

“I’m glad to tell you that Comirnaty from today has received approval for children five to 11 years of age,” said Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EMA), using the vaccine’s brand name.

“This is based on a different dose in the one used in adults, essentially it’s a much lower dose,” he told an online public meeting.

The vaccine was already cleared for use in people aged 12 and over in the 27-nation EU.

Children aged five to 11 will be given one third of the dose that older people receive, with two injections, three weeks apart, the EMA said in a statement.

The vaccine was 90.7 percent effective in a study of nearly 2,000 children of that age, it added.

Side effects were usually “mild or moderate” lasting a few days, and included pain in the injection site, tiredness, headache, muscle pain and chills.

The EMA “therefore concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19.”

The EU Commission will now likely approve the vaccine for children aged 5 to 11 but the ultimate decision over whether to roll out the Covid jab to yound kids will rest on the government of each member state.

France on Thursday said ministers were examining rolling out the vaccine to the age group but said there would be no decision before 2022.

But the Pfizer jab’s safety in children “will continue to be monitored closely”.

Health authorities say children make up an increasing proportion of new cases and hospitalisations in Europe, which is back at the centre of the coronavirus pandemic.

Children are also considered key drivers of infections even when they themselves do not come down with symptoms.

In the Netherlands, where the EMA is based, authorities said earlier this week that the largest increase in cases was among children up to the age of 12.

“We know that severe Covid-19 and death remain quite rare in children, however disease of all severity occurs in all the paediatric ages,” Cavaleri said.

“Moreover, high transmission results in increased hospitalisation in children of all ages.”

While children with underlying health conditions were more likely to become ill, the majority of children in hospital with Covid were otherwise healthy, said Cavaleri.

They were also at risk of so-called “long Covid” symptoms dragging on for months after infection, and multisystem inflammatory syndrome, he added.

The EMA is separately reviewing Moderna’s coronavirus vaccine for children aged 6-11 and expects to reach a decision in January.

The regulator has so far approved four vaccines for use for adults in the EU: Pfizer and Moderna, which use messenger RNA technology, and AstraZeneca and Johnson & Johnson, which use viral vector technology.

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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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