Flu vaccine fears continue as deaths invstigated

Pharmaceutical agency investigating, says no clear link

Concerns continued across Italy after the recall of batches of a flu vaccine that may be linked to as many as a dozen deaths in six regions. Prosecutors in at least four Italian cities were investigating the deaths of people after they received the Fluad vaccine.
    The Italian Pharmaceutical Agency (AIFA) recalled two batches of the vaccine for study into possible contamination and warned clinics and patients to search for any products from those two lots.
    After thousands were found and turned in, health authorities in several regions resumed treating patients with the Novaris Fluad vaccine.
    In preliminary tests of the two recalled lots, AIFA said that there wasn't any evidence that the product had been contaminated and there were no signs that there were any defects in production. AIFA also said the deaths that had been linked to the vaccine were mainly cardiovascular-related and could have been the result of pre-existing illnesses.
    The agency said the recall was taken as a precautionary measure.
    "At this point, it is not clear if there is a causal relationship or a link to the vaccination," AIFA said in a recent statement.
    "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".
    The Swiss pharmaceutical giant Novartis defended its safety record, saying it is "robust".
    The recall affected lots numbered 142701 and 143301, produced in a Novartis lab in the central Tuscan town of Siena, and came after tens of thousands of vaccines had been injected.
    In Tuscany, 60,000 doses of the two recalled lots of Fluad had been administered before the recall was issued, said Luigi Marroni, Tuscan regional health commissioner.
    Health authorities in the northwestern Liguria region temporarily suspended flu vaccinations on Thursday while clinics and pharmacies checked their stocks for the suspicious batches.
    Some 1,500 doses from the suspicious lots were found and removed and on Friday Liguria health clinics re-commenced vaccinations.
    In Lazio, doses of the recalled lots of vaccine were distributed in Rome and surrounding towns, said Pier Luigi Bartoletti, regional secretary of the Italian Federation of Family Doctors (FIMMG).
    Bartoletti said it would take a few days to determine how many doses of the recalled vaccine had been injected in the region.
    He added that Fluad is not a general-use flu vaccine and is used selectively for the elderly or those with compromised immune systems.
    "(The vaccine) is only used in particular cases, for example with elderly patients, or those with serious chronic illnesses or immunodeficiencies," Bartoletti said.
    Sicily's regional health commission said that the recalled vaccines had been distributed primarily in Siracusa, where 16,560 doses had been administered, and in Catania, where 3,310 doses were administered.
   

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