Novartis' flu vaccine in the clear over 19 deaths, says Italian regulators

By Dan Stanton contact

- Last updated on GMT

Novartis' Fluad deemed safe following reports of related deaths
Novartis' Fluad deemed safe following reports of related deaths

Related tags: Flu vaccine, Influenza vaccine, Influenza, Vaccine

Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.

Last week this publication reported three people died​ shortly after receiving a dose of the trivalent influenza vaccine Fluad in Italy, and by Sunday the number of deaths had reportedly risen to 13​.

Novartis, which manufactures Fluad, told us “no causal relationship”​ had been established between the vaccine and the deaths, and yesterday the Italian regulatory body AIFA confirmed the results of an analysis of the two batches in question – 143,301 and 142,701 – came back “completely negative.”

“Test results confirm the safety of the flu vaccine, exclude the presence of endotoxins, and show the batches conform to the appearance and​ content of the vaccine antigen of the influenza virus,”​ a translation of AIFA’s statement said.

Though the number of people who died after receiving a dose of Fluad was reported to have reached 19 yesterday, AIFA said these had come from eight different batches and was attributable to “the greater sensitivity shown by health professionals and the general population to the phenomenon because of mediated events of recent days.”

It is  advised those at risk from seasonal flu to continue to be vaccinated, a sentiment shared with the European Medicines Agency (EMA) which worked with AIFA in the investigation. This issue referred specifically to the two batches of Fluad, the agency said in a statement sent to this publication. “Influenza vaccines are the most effective way to prevent the disease and/or the serious complications it can cause.”

Fluad is made by using embryonated hens’ eggs to grow individual virus strains, which are then harvested and clarified by centrifugation and filtration. The vaccine contains the adjuvant MF59 which, according to Novartis offers various degrees of cross-protection and greater antibody response compared with other seasonal vaccines.

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