After Aifa’s green light for immunization of the 5-11 year old age group, the calendar for pediatric vaccination against Covid arrives in Italy. The international debate on the immunization of the younger population has been open for months as it had already happened for adolescents. The chairman of the German Stiko Vaccine Commission at the Robert Koch Institute, Thomas Mertens, on the basis of the data currently available “would not vaccinate their children against Covid”. A statement made in the “Podcast fuer Deutschland” of the Frankfurter Allgemeine Zeitung, which today brings the news on the front page. In addition to studies for authorization, “there is no data of any kind“On the compatibility of the vaccine in the range between 5 and 11 years. Current publications, he says, show that no long-term damage claims are possible.
The data we have on the anti Covid vaccine in the 5-11 age group “are not few” says Maria Paola Trotta, coordinator of the Aifa crisis unit dedicated to Covid, on Radio 24. “The registration study that led to the new indication has included over 3,000 vaccinated children and the data showed high levels of effectiveness around 91% “. To these data are added “those included in the US pharmacovigilance database, where he left on October 29 and over 3 million children have been vaccinated. Here too, although the follow-up is not very long, no particular safety problems are highlighted “.
For the opinion on the extension of the indication of the anti Covid vaccine to children between 5 and 11 years, stressed Trotta, “all the data have been reviewed, not only those of the registration studies, and therefore the dossier presented to the Agency European Medicines, but the Scientific Technical Commission of the Italian Medicines Agency has also taken care to try to obtain information also from the accessible data of the United States pharmacovigilance databases, which concern spontaneous reports“.
“Like all decisions made in this period – he continued – they will be adapted to the best evidence that is generated over time”, because “knowledge evolves continuously. But already now we can say that with three million children vaccinated, if there had been important signs they would have been visited and known“.
“The data we have on the Covid vaccine for children is sufficient for this pediatric extension. We have a study done on 3000 children, with a reduced dose, that is 1/3 of the dose: the vaccine remains effective and without worrying adverse events, only local reactions, some fever and headache. For now, there are no myocarditis, ”said Patrizia Popoli, president of the Aifa technical-scientific commission on Radio too. “Covid in children is not always mild, for example there is multisystem inflammatory syndrome and this can be serious. Six out of 1000 children end up in hospital. There is a risk“.
In the United States, the age group 5-11 years ago started vaccinating a month and 3 million and 300 thousand children have been immunized with at least one dose (on an audience of over 28 million). In Israel, on the other hand, the pediatric vaccination campaign started ten days ago and over 35 thousand children received the first injection, 4.5% of the audience. Worldwide, the other countries in which the youngest are already immunizing (starting from 2 or 3 years old) are China, Canada, United Arab Emirates, Cambodia, Argentina, Chile, Venezuela and Cuba. In France, vaccination is currently recommended but only for fragile children, “who risk developing a severe form of the disease and die” or who “live in the entourage of immunocompromised or vulnerable people, not protected by vaccination”