Italy has authorized the Moderna Spikevax coronavirus vaccine for minors aged between 12 and 17, the country’s health authority said on Wednesday.
The decision came after European Union Medicines Agency (EMA) on July 23 had recommended extending the use of the vaccine to this age group, Xinhua news agency reported.
The Spikevax vaccine (previously Covid-19 Vaccine Moderna) is already authorized for use in people aged 18 and above in the European Union (EU).
The Italian Medicines Agency (AIFA) has accepted the recommendation, saying that its technical-scientific committee had also greenlighted it after reviewing the available data, which “prove the effectiveness and safety of the vaccine also for people in that age group”.
According to the EMA, the effects of Spikevax on minors have been investigated in a study involving 3,732 children aged between 12 and 17. The study showed that the vaccine had produced “a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years (as measured by the level of antibodies against SARS-CoV-2),” the EMA said last Friday.
In addition, none of the 2,163 children vaccinated with Spikevax have developed Covid-19 symptoms compared with four of the 1,073 children given placebo. The EU agency therefore concluded that the efficacy of Spikevax in minors aged 12 and above “is similar to that in adults”.
To date, over 31 million people in Italy — or 57.4 per cent of the target population aged 12 and above — have already been fully immunized, according to the Health Ministry.
Some 66.4 million vaccine doses have been administered so far. Yet, Prime Minister Mario Draghi’s cabinet is trying to accelerate the vaccination campaign across the country in light of the new rise in infections brought about by the Delta coronavirus variant.
The seven-day incidence rate of new Covid-19 cases in Italy increased to 31 per 100,000 population in the week of July 12-18 compared to 14 cases a week earlier, the National Health Institute’s (ISS) latest monitoring report showed.
Italy has recorded 4.3 million Covid-19 cases since the start of the pandemic in February 2020. This total includes 70,310 active infections, over 4.1 million recoveries and 127,995 fatalities.
