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Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA approves Comirnaty vaccine for ages 5 to 11 - AIFA approves Comirnaty vaccine for ages 5 to 11

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AIFA approves Comirnaty vaccine for ages 5 to 11

Press release no. 674 - On 1st December 2021 the AIFA Scientific-Technical Committee (CTS) approved the extension of indication of use of the Comirnaty (Pfizer) vaccine for the 5-11 years age group, with a reduced dose (one third of the authorised dosage for adults and adolescents) and with a specific formulation. The vaccination will take place in two doses three weeks apart. The CTS points out that the available data show a high level of efficacy and no safety signals have been reported do date.
To avoid any administration error, the CTS recommends that the above age group be exclusively administered the ad hoc pediatric formulation, suggesting vaccination courses appropriate to age, where possible.
In its opinion, the CTS notes that “although SARS-CoV-2 infection is certainly more benign in children, in some cases it can be associated with serious consequences, e.g. the risk of developing multisystem inflammatory syndrome (MIS-c), which may also require hospitalisation in intensive care unit”. Finally, the CTS highlights that “vaccination brings benefits such as the possibility of attending school and leading a social life with valuable recreational and educational elements, particularly important for mental and personality development in this age group”.


Published on: 01 December 2021

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