COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch used in Austria
Austrian national competent authority has suspended use of a batch of COVID-19 Vaccine AstraZeneca (batch ABV5300) after 2 cases of thromboses. The EMA states there is currently no indication vaccination has caused these conditions; its safety committee is reviewing this issue.
Source:
European Medicines Agency
SPS commentary:
As of 9 March 2021, two other reports of thromboembolic event cases had been received for this batch which was delivered to 17 EU countries. Some EU countries have also subsequently suspended this batch as a precautionary measure, while a full investigation is ongoing. Although a quality defect is considered unlikely at this stage, the batch quality is being investigated.
The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population. As of 9 March 2021, 22 cases of thromboembolic events had been reported among the 3 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.
In response to Danish authorities’ action to temporarily suspend the AstraZeneca COVID-19 Vaccine, the MHRA stated this is a precautionary measure by the Danish authorities, it has not been confirmed that the report of a blood clot was caused by AstraZeneca COVID-19 Vaccine, and people should still go and get their COVID-19 vaccine when asked to do so.