While in Italy there is again discussion about the age limits of the AstraZeneca vaccine, Germany has decided to advise against the use of the vaccine Pfizer “in children and adolescents aged 12 to 17 years with no previous illness“. An abrupt stop to the vaccination of the very young for the Teutonic country, given that at the moment Pfizer is the only one approved by the EMA for subjects under 16 years old.
As in our country, its use is not prohibited but the Standing Committee for Vaccination (Stiko) of the Robert Koch Institute does not recommend its administration in younger subjects. The explanation of this decision is contained in a 30-page dossier, which will also be accompanied by an information document drawn up as a faq for parents and pediatricians, in order to provide all the information necessary for the evaluation of each individual case.
Stiko’s decision is based on currently available data, explaining that the use of Pfizer vaccine is not currently recommended in healthy individuals. “but it is possible after medical advice and with individual will and relative acceptance of the risk“. In Germany it was decided to recommend vaccination of the very young only in subjects with pathologies or situations that may contribute to developing the disease in serious form. These include, for example, obesity, heart defects and diabetes. But not only that, because Stiko has foreseen that young people between 12 and 17 years of age can also receive the vaccine who, however, “are close to relatives or other people at high risk for a severe Covid course and who cannot be vaccinated“.
The doubts of the Robert Koch Institute arise from the lack of data currently available to the EMA to authorize the administration of vaccines in the very young. “The number of children and adolescents vaccinated in the approval study controlled was small (about 1,000), and on the other hand the mean follow-up time (1-2 months) was short“, explained the German experts who came to this decision. But there are also other data that prompted Stiko to ask for a step back, in particular for the”indications of the onset of myocarditis, which has been observed sporadically in young men after vaccination with Comirnaty in some countries“.
Germany’s caution was commented on by Antonella Viola to the Corriere della Sera: “The numbers are too low to see effects manifesting with an incidence of 1/100, this is true, but it was also based on the fact that these vaccines in boys aged 16 and over have already been used in the United States and in Israel and there were no health problems. Once the vaccine is considered safe in adults in large numbers, smaller numbers can then be used for efficacy and safety studies in adolescents.“.
The immunologist, therefore, while considering the German attitude “acceptable”, underlines “that Pfizer vaccine is safe for now“. Its evaluation is based on the absence of cases that have given rise to alarms for its use, as happened with AstraZeneca.”There have been very few cases of myocarditis affecting mainly young males, but myocarditis was treated with cortisone and resolved after two days in hospital“, said Antonella Viola. The experimentation of the Pfizer vaccine on very young people has been underway since May in Israel and at the moment no criticalities are reported.