Legal and ethical issues around Covid-19 vaccination consent In Italian children from 12 years of age

In Europe, there are currently two vaccines against COVID-19 recommended by the European Medicines Agency (EMA) for children aged 12 and older: Spikevax (Moderna) and Comirnaty (Pfizer-BioNTech). At the moment, about half of European countries have decided to age 12 as the minimum age for vaccination against COVID-19. In addition to Italy, France, Spain, Austria, Slovenia, Hungary, Czechia, Slovakia, Denmark, Switzerland, Romania, Bulgaria, Lithuania, Latvia and Estonia. Others (Germany, UK, Netherlands, Belgium, Sweden, Finland) recommend vaccination only for children in textual conditions facing COVID-19 or living with frail people. The Italian Medicines Agency (AIFA) has approved the extension of the therapeutic indications for Comirnaty on May 31 and for Spikevax on July 29, 2021. The various scientific societies in Italy (SIPPS, SIP) agreed in favor of vaccinating children from 12 years old. However the problem of informed consent to COVID-19 vaccination in minors is absolutely emerging, in Italy as well as in other countries (Heuerman, 2021). According to national and international conventions, he should be informed, listened to and must participate in the co-decision process regarding medical treatment. Achieving a “triple” medical-parent-child therapeutic alliance is the main goal at this time of the pandemic, but this is not always possible (Morgan, 2021). The main key legal and ethical issues on the matter are represented below.