Italy’s medicines agency AIFA approved the use of the Pfizer Comirnaty vaccine in children aged 5-11 on Wednesday evening, after the European Medicines Agency (EMA) issued its approval last Thursday.
“The available data show a high level of efficacy and no warning signals are currently highlighted in terms of safety,” AIFA said in a press release on Wednesday.
In a statement released on its website last week, the EMA said that of 1,305 children who received the vaccine in trials, three developed COVID-19, compared to 16 out of the 663 children who received a placebo – meaning that the vaccine was 90.7% effective at preventing symptomatic COVID-19 in this study.
The EMA’s human medicines committee concluded that “the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19,” the agency said.
Here’s what we know so far about how Italy will administer the vaccine in children.
When will 5-11 year olds in Italy be able to get their first vaccine?
Italy’s health authorities are expected to start administering vaccines to 5-11 year olds before Christmas.
Most regions will likely begin vaccinating December 20th and December 25th, according to the news daily Corriere della Sera.
Franco Locatelli, the head of the Italian government’s Scientific Technical Committee, told Sky TG24 that doses for children will be available in Italy from December 23rd.
When will bookings open for this age group?
It’s anticipated that most regions will open bookings for 5-11 year olds at some point on Thursday.
The booking will need to be made through the website of your local health authority, as health services in Italy are managed on a regional basis.
The Local has compiled a list of links to local health authority websites for each region and autonomous province in Italy here.
Where will children be vaccinated?
Vaccines for 5-11 year olds will be administered in the existing vaccination hubs across the country where people aged 12 and up have already received the vaccine.
“We plan to use all available resources where feasible: so we’ll also open up to paediatrician’s offices and pharmacies,” Italy’s undersecretary of health Pierpaolo Sileri is reported to have said.
How will the vaccines be administered to children?
Each child who receives the vaccine will need to be accompanied by a parent.
Children aged 5-11 will receive the EMA’s approved dosage of 10µg, or micrograms, as opposed to the 30µg dosage given to those aged 12 and up.
The second dose will be administered three weeks after the first.
Will the vaccine be made mandatory for children?
The vaccine is not mandatory for children.
Those under the age of 12 in Italy are not required to have the Italian Covid health certificate or ‘green pass’, or its successor, the ‘super green pass’ (available only to those who are vaccinated against or recovered from Covid) to access any events or facilities.
Will children who have recovered from Covid be offered the vaccine?
Yes – though it’s unclear at this stage whether they will be offered one dose or two, reports Corriere della Sera.