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The Health Products Regulatory Authority of Ireland has said it is closely following an Austrian investigation into reports of adverse events after vaccinating a batch of the AstraZeneca vaccine.
Austrian authorities are investigating the death of one person and the illness of a second after receiving the vaccine and have suspended inoculations of a specific lot of AstraZeneca as a precautionary measure.
“The Federal Office for Safety in Health Care (BASG) has received two reports in a temporary connection with a vaccine from the same batch of the AstraZeneca vaccine in the district clinic of Zwettl”, in the province of Lower Austria, He said.
A 49-year-old woman died as a result of severe bleeding disorders, while a 35-year-old woman developed a pulmonary embolism and is recovering, he said. A pulmonary embolism is an acute lung disease caused by a dislodged blood clot.
In a statement tonight, the HPRA said there is currently “no evidence of a causal relationship” between the vaccine and the events.
It says the suspension of this specific batch is a “precautionary measure by the Austrian regulator pending further investigation.”
The HPRA says that tens of millions of doses of this vaccine have been used worldwide and that the reported side effects have been in line with those identified during clinical trials and that the benefit-risk profile of this particular vaccine follows being positive.
“There is no confirmation that the vaccine caused these events,” he said in a statement.
The Authority will continue to monitor the situation together with the European Medicines Agency and other national authorities in Europe.
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