Italy bans AstraZeneca batch following two deaths in Sicily

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.

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.

Italy bans AstraZeneca batch following two deaths in Sicily

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.

Austria announced on Monday it had suspended the use of the particular AstraZeneca batch after a 49-year-old nurse died of severe blood coagulation days after receiving the shot.

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.

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 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 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 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.

Italy is struggling to move forward with its massive vaccination plan, as some of the vaccine producers have announced delays in their supplies.

Statement from AIFA – Agenzia Italiana del Farmaco – Italian Medicines Agency

AIFA DISPONE DIVIETO DI UTILIZZO DI UN LOTTO ASTRAZENECA
ACCERTAMENTI IN CORSO IN COORDINAMENTO CON EMA
A seguito della segnalazione di alcuni eventi avversi gravi, in concomitanza temporale con la
somministrazione di dosi appartenenti al lotto ABV2856 del vaccino AstraZeneca anti COVID-19,
AIFA ha deciso in via precauzionale di emettere un divieto di utilizzo di tale lotto su tutto il territorio
nazionale e si riserva di prendere ulteriori provvedimenti, ove necessario, anche in stretto
coordinamento con l’EMA, agenzia del farmaco europea.
Al momento non è stato stabilito alcun nesso di causalità tra la somministrazione del vaccino e tali
eventi.
AIFA sta effettuando tutte le verifiche del caso, acquisendo documentazioni cliniche in stretta
collaborazione con i NAS e le autorità competenti. I campioni di tale lotto verranno analizzati
dall’Istituto Superiore di Sanità.
AIFA comunicherà tempestivamente qualunque nuova informazione dovesse rendersi disponibile.

Italy bans AstraZeneca batch following two deaths in Sicily