MHRA response to Danish authorities’ action to temporarily suspend the AstraZeneca COVID-19 Vaccine
Agency states 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.
Source:
Medicines and Healthcare products Regulatory Agency
SPS commentary:
The Austrian national competent authority has suspended use of a batch of COVID-19 Vaccine AstraZeneca (batch ABV5300) after 2 cases of thromboses. The European Medicines Agency states there is currently no indication that vaccination has caused these conditions; its safety committee is reviewing this issue. As of 9 March 2021, two other reports of thromboembolic event caes 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.