Concerns were raised across
Italy Friday after the recall of batches of a flu vaccine that
were possibly linked to as many as five deaths.
More reports were being investigated of possible illness or
death related to the vaccine Fluad, the head of the Italian
Pharmaceutical Agency (AIFA) said Friday.
"We are getting other reports that we are examining," and
other lots of the vaccine may be withdrawn, said Luca Pani, as
some regional health authorities across Italy weighed whether to
temporarily suspend flu vaccinations.
Pani added that the new reports may be linked to a kind of
hysteria brought on by media coverage of the deaths.
Prosecutors in Tuscany said they were investigating the
death of an 80-year-old man in the Tuscan city of Prato, whose
case had initially been connected with the Fluad vaccine,
although later reports said the connection was not clear.
Still, his body may be exhumed as part of the investigation
into his death, said authorities.
The controversy become public Thursday when AIFA recalled
two batches of the vaccine produced by Swiss multinational
pharmaceutical giant Novartis for examination 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 Fluad vaccine.
Still others, including the Lazio region, home to Italian
capital Rome, said it would suspend use of the vaccine pending
more information.
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
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".
Novartis defended its safety record, saying it is "robust"
and added that the two lots withdrawn by the AIFA were not sold
to the public through pharmacies but only distributed through
regional health agencies.
Two men and two women died after receiving the vaccine,
including two people in Sicily, aged 68 and 87; a third aged 79
in the southern Molise region; and a fourth in Lecce, a leading
city in Puglia in the country's southeast corner.
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
around the country.
Prosecutors in Siena said Friday they were going to
investigate the suspect vaccines.
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 resumed
vaccinations.
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