Following the reports of four serious or fatal adverse events, which occurred in temporal concomitance with the administration of doses from the two lots 142701 and 143301 of the fluad flu vaccine by Novartis Vaccines and Diagnostics srl, pending the availability of the necessary elements, among which the outcome of the investigations on the samples already taken, in order to evaluate a possible causal link with the administration of the doses of the two lots of the vaccine, the Italian Medicines Agency (AIFA) has ordered, as a purely precautionary measure, the ban on the use of such lots.
AIFA invites patients who have packages of the FLUAD vaccine at home to check the lot number on the package and, if it corresponds to one of those for which a ban on use has been ordered, to contact their doctor for evaluation of a vaccine alternative.
AIFA also specifies that the three events with a fatal outcome had their onset within 48 hours of the administration of the doses of the two batches of the vaccine.
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AIFA: “Prohibition on using Fluad batches only as a precaution. Vaccines are a precious and irreplaceable resource”
The Italian Medicines Agency recalls that vaccines are a precious and irreplaceable resource for the prevention of seasonal influenza and its complications, which can give rise to cases of severe intensity and affect more frequently in particular the over-65s and patients suffering from pre-existing chronic conditions.
AIFA underlines that the provision issued today, which provides for the prohibition of the use of two batches of the drug FLUAD, was taken for exclusively precautionary purposes, following reports received by the Agency from the National Network of pharmacovigilance.
Adverse reactions have been reported in the cases in question following the administration of the vaccine and deaths have occurred in three cases, but at the moment it is not certain whether this is a coincidence or if there is a link with the vaccination.
A complete picture can only be provided after analyzing all the elements of the context, including, for example, the state of health of the patients, their age and any pathologies they were suffering from.
In any case, AIFA renews the invitation to those who have undergone vaccination with one of the batches subject to the ban on use to contact their doctor.
