The anomaly, which should affect about 500 doses, would consist in the formation of particles of protein aggregates
No alarm. Be careful, though. So, if you bought a Novartis flu vaccine at the pharmacy, wait a few more days for it to be administered. And if you've already used it, don't panic: it could all be resolved with some unwanted reaction at a local or systemic level, such as a rise in body temperature (a mandatory condition, as always in these cases).
The message launched by the Minister of Health, Renato Balduzzi, is clear: the 500 doses of Novartis' flu vaccine have been blocked in pharmacies and warehouses and their sale has been prohibited for precautionary reasons, not because adverse reactions have been reported, at least until now.
The story – It all kicked off last Monday 19 October, when, on the sidelines of a meeting at Aifa (our drug agency) on other issues, some pharmaceutical company representative communicated, informally, that anomalies were found in some , very limited, batches of vaccines intended for the flu campaign. Aifa therefore asks to investigate the matter further and asks the company to produce the necessary documentation. From acquired cards Aifa arrives at the determination that the company knew of the anomalies since 11 last July, but, probably considering them irrelevant, he had not formally communicated them to the Agency. Which, having concluded the "technical" evaluation of the documentation, informed the Ministry of Health that, on the afternoon of 24 October, it ordered the ban on the sale of Novartis vaccines.
The anomaly – As far as we know, the anomaly would consist in the formation of particles of protein aggregates which should not cause ser reactions
