ROME (Reuters) – Italy’s pharmaceutical watchdog AIFA said on Monday that tests on an anti-flu vaccine that it suspended last week over health concerns had shown the drug was safe.
AIFA on Thursday suspended two batches of the FLUAD vaccine made by Switzerland’s Novartis, saying three deaths potentially connected to the drug had been reported.
The suspension sparked widespread alarm in Italy, and 16 more deaths have been reported among people who had used the vaccine. However experts expressed scepticism that the deaths were linked to the drug and health authorities urged people to continue to vaccinate themselves.
“The results of the tests confirm the safety of the anti-flu vaccine,” AIFA said in a joint statement issued with the health ministry. The tests on the suspended batches were “completely negative”.
It said reports of deaths linked to the vaccine presented by doctors or relatives should therefore be attributed to the heightened media attention on the issue, not to the drug.
The statement noted that around 8,000 Italians die of flu every year and it urged people not to stop vaccinating, especially those over the age of 65.
Novartis said last week that more than 7 million doses of FLUAD had been distributed this year worldwide and no unusual frequency of adverse effects had been reported.
AIFA did not indicate whether it now planned to release the two batches of FLUAD it had suspended.
(Reporting by Gavin Jones; Editing by Pravin Char)