Italy has suspended the use of two batches of Fluad, a flu vaccine made by Swiss pharmaceuticals giant Novartis on Thursday after 3 people died shortly after receiving the drug.
According to Bloomberg, a fourth person had a “serious adverse event” after getting the Basel, Switzerland-based company’s vaccine, the Italian Pharmaceutical Agency said in a statement today. The suspension of the two batches is a precaution, the Italian agency, known as AIFA, also said. It’s unclear whether the deaths were a coincidence or were linked to the vaccine, it said
The BBC report that two women and two men aged between 67 and 87 died.
Novartis said “no causal relationship to the vaccine has been established“.
Fluad is a flu vaccine given to the elderly, which was approved in 1997.
In a statement, Aifa said: “At this point, it is not clear if there is a causal relationship or a link to the vaccination.
“A full picture will be formed only after a full analysis of all aspects, including the general health of the patients, their ages and probable conditions they might have had.”
Novartis said it had a “robust” safety history.
A review of the two batches in question has “confirmed that they are in conformity with all production and quality standards,” the company said.
Health officials called for calm as news of the ban spread. Italian consumer association Codacons called on the health minister to suspend pro-vaccination campaigns, but AIFA insisted vaccines were “a precious resource and irreplaceable for the prevention of seasonal flu” reported Channel NewsAsia
“We need to make sure that the number of people who get vaccinated does not drop. We have to have faith in vaccines,” said AIFA head Sergio Pecorelli, who added that “8,000 people die of seasonal flu” each year.