(Adds details about deaths, further background)
ROME, March 11 (Reuters) - Italian health authorities have
ordered the withdrawal of a batch of AstraZeneca
coronavirus vaccine following the deaths of two men in Sicily
who had recently been inoculated, a source close to the matter
said on Thursday.
Italy's medicines authority Aifa confirmed that it was
halting the use of a batch of doses as a "precautionary"
measure, adding that no link had been established between the
vaccine and subsequent "serious adverse events".
It did not specify what incidents it was referring to.
However, the source said health authorities moved following
the deaths this month of Stefano Paterno, a 43-year-old navy
officer, and Davide Villa, a 50-year-old policeman, who had both
received shots from AstraZeneca's ABV2856 batch.
Paterno died of a suspected heart attack on Tuesday, the
day after his shot. Villa died at the weekend, some 12 days
after his inoculation.
Local newspapers said he fell ill within 24 hours of his
injection, and reported that doctors had diagnosed a deep vein
thrombosis, which later resulted in a brain haemorrhage.
Italy's move came hours after Denmark and Norway announced
they were temporarily suspending the use of AstraZeneca's
vaccine shots after reports of the formation of blood clots in
some who have been vaccinated.
AstraZeneca on Thursday told Reuters in a written statement
the safety of its vaccine had been extensively studied in human
trials and peer-reviewed data had confirmed the vaccine was
generally well tolerated.
The drugmaker said earlier this week its shots were subject
to strict and rigorous quality controls and that there had been
"no confirmed serious adverse events associated with the
vaccine".
In a separate development, Austria on Sunday stopped using a
batch of AstraZeneca shots while investigating a death from
coagulation disorders and an illness from a pulmonary embolism.
The batch involved in that case was not the same as the batch
under review in Italy.
Italy's Aifa said it was working closely with the European
Union's drug regulator, the European Medicines Agency (EMA),
over the the issue.
Magistrates on the Mediterranean island have opened
investigations into the deaths of both Paterno and Villa,
neither of whom was believed to had previous health problems.
(Reporting by Emilio Parodi and Angelo Amante; Writing by
Crispian Balmer; Editing by Gavin Jones)