Italy to expand its covid vaccination campaign to 5-11 year olds after all-clear from AIFA.
Italy's medicines agency AIFA on Wednesday evening authorised the Pfizer-BioNTech covid-19 vaccine for children aged five to 11.
The news comes a week after the EU medicines regulator EMA approved the Comirnaty vaccine developed by Pfizer and BioNTech, recommending that children get two doses of 10 micrograms, three weeks apart. Adult doses contain 30 micrograms.
AIFA said in a statement that the data available "demonstrates a high level of efficacy and there are currently no warning signs in terms of safety", reports news agency ANSA.
Deputy health minister Andrea Costa, speaking on Radio 105 earlier on Wednesday, stressed: “We have to say with clarity that the vaccine will be voluntary and that there is no Green Pass planned for the under-12s”.
Health minister Roberto Speranza, during the recent unveiling of Italy's Super Green Pass rules, said that all going to plan Italy should receive the vaccine doses for children towards the end of December.
News of the all-clear from AIFA came the same day that Italy expanded its covid vaccination drive to make the third dose, or booster shot, available to everyone over the age of 18.
Also on Wednesday the president of the European Commission, Ursula von der Leyen, said that EU countries should consider mandatory vaccination to combat covid and the "highly contagious" new Omicron variant.
The green light from the EMA clears the way for vaccines to be given to millions of children in Europe amid a new wave of covid infections sweeping across the continent.
The EMA’s human medicines committee (CHMP) said in a statement last week that the most common side effects from the vaccine in children aged 5 to 11 are "similar to those in people aged 12 and above."
These include "pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills".
However the CHMP stressed that these effects are "usually mild or moderate and improve within a few days of vaccination."
It 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."
As of Wednesday night more than 87 per cent of Italians over the age 12 have had at least the first dose of the covid vaccine, according to the latest data from the government.