Novartis knew of the aggregation of proteins, detected in the Agrippal vaccine, as early as July 11, but did not send any communication to AIFA before October 19, when the vaccination campaign had already begun. This was confirmed by AIFA which asked Novartis to urgently send "to the ISS an adequate number of samples of Agrippal filled batch 126303 (in which protein aggregates were found), as well as a suitable number of samples for batches 126301 and 126302, in order to repeat all the tests deemed appropriate and necessary", as requested by Minister Balduzzi.
AIFA specifies that at the time of detection of the problem by Novartis "the annual update procedure of both Agrippal and Fluad flu strains was underway and in this context it would have been possible to intervene and discuss it at European level". The company continued to omit information about the presence of aggregates in vaccines, including in August, during the data integration phase. Indeed, Novartis "has requested the closure of the annual change in flu strain despite the problems highlighted above".
The Nas, in collaboration with FOFI and Federfarma, are verifying how many doses of Novartis flu vaccines have been given by pharmacies to their customers; checks are underway at wholesalers and at 1,603 public pharmacies, 800 hospital pharmacies and 16,012 private pharmacies.
Novartis will have to provide detailed answers, within 7 working days, on the characteristics of the protein aggregates, the frequency of the defect in the finished product and other more specific information of a technical nature to allow the control body to carry out the investigations.
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