Italy’s medicines agency AIFA gave the go-ahead for the use of Pfizer-BioNTech’s COVID-19 vaccine for children between the ages of five and 11.
AIFA’s decision, which was widely expected, came after the European Union’s drug regulator (EMA) took the same step on Nov. 25.
The approvals come as Europe emerges as the epicentre of the latest phase in the coronavirus pandemic, accounting for about half of worldwide cases and deaths in recent weeks.
EMA recommended on Nov. 25 that Pfizer-BioNTech’s, vaccine be given to 5-11 year olds as an injection in the upper arm in two 10 microgram doses, three weeks apart.
Adult doses contain 30 micrograms.
In making the same recommendation for use as the EU agency did, AIFA said the available data “shows a high level of efficacy, with no signs of alert at the moment in terms of safety.”
The vaccine has been approved for European Union use in teenagers between 12 and 17 years old since May, with the same dosage as for adults.
Inoculating children and teenagers, who can unwittingly transmit COVID-19 to others, is considered by health authorities to be a crucial step towards taming the pandemic.
With infections on the rise in Italy, the government last week tightened the screws on people unwilling to take an anti-COVID shot, sharply restricting access to an array of services and making vaccines mandatory for a wider group of public sector workers.
Italy reported 103 coronavirus-related deaths on Wednesday, the first daily death toll of more than 100 since June 8.
The country has registered 133,931 COVID deaths since its outbreak emerged in February last year, the second-highest tally in Europe after Britain and the ninth-highest in the world. It has reported 5.04 million cases to date.