Danish, Norwegian and Icelandic authorities suspend use of COVID-19 Vaccine AstraZeneca

The Austrian national competent authority (Finanzmarktaufsicht [FMA]) has suspended use of the ABV5300 batch of the COVID-19 Vaccine AstraZeneca, after a person was diagnosed with multiple thrombosis and died 10 days after vaccination and another was hospitalised with pulmonary embolism  after being vaccinated.

According to the European Medicines Agency, as of 9 March 2021, two other reports of thromboembolic event cases had also been received for this batch. However, there is currently no indication that the vaccine caused the complications and the EMA stated that 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 three million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.

Batch ABV5300 was delivered to 17 EU countries and comprises 1 million doses of the vaccine. Some EU countries have also subsequently suspended this batch as a precautionary measure, while a full investigation is undertaken. The Danish, Norwegian and Icelandic authorities’ have also taken the decision to temporarily suspend use of the vaccine while this is ongoing.

The EMA said that, though a quality defect is considered unlikely at this stage, the batch quality is being investigated. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is also reviewing the issue and will investigate the cases reported with the batch as well as all other cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination.

In response to the Danish, Norwegian and Icelandic authorities’ action to temporarily suspend use of the AstraZeneca COVID-19 Vaccine, Dr Phil Bryan, the UK Medicines and Healthcare products Regulatory Authority (MHRA)’s Vaccines Safety Lead said: “Vaccine safety is of paramount importance and we continually monitor the safety of vaccines to ensure that the benefits outweigh any potential risks.

“It has not been confirmed that the report of a blood clot, in Denmark, was caused by the COVID-19 Vaccine AstraZeneca. The Danish, Norwegian and Icelandic authorities’ action to temporarily suspend use of the vaccine is precautionary whilst they investigate.

“Blood clots can occur naturally and are not uncommon. More than 11 million doses of the COVID-19 Vaccine AstraZeneca vaccine have now been administered across the UK. Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population.

“The safety of the public will always come first. We are keeping this issue under close review but available evidence does not confirm that the vaccine is the cause. People should still go and get their COVID-19 vaccine when asked to do so.”