“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“He said it Patrizia Popoli, president of the technical-scientific commission of Aifa 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”.
The data we have “are not few”. “The pivotal study leading to the new indication 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 they left on October 29 and over 3 million children were vaccinated. Even here, although the follow-up is not very long, no particular safety problems are highlighted. “So Maria Paola Trotta, coordinator of the Aifa crisis unit dedicated to Covid, on Radio 24.
For the opinion on the extension of the indication of the anti Covid vaccine to children between 5 and 11 years, said Trotta, “all the data have been reviewed, not only those of the registration studies, and therefore the dossier presented to the Agency European Medicines Commission, 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 pharmacovilitary database, 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 if there were important signs, they would have been visited and known “.
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