A number of countries in Europe on Thursday suspended use of AstraZeneca's COVID-19 vaccine after a number of reports of serious side effects, including several cases of blood clots. The move comes shortly after five European countries stopped using a specific batch of the vaccine after one recipient was diagnosed with multiple thromboses and another was hospitalised with pulmonary embolism.
The European Medicines Agency (EMA) recently noted that a further two reports of thromboembolic events had been received for this batch, with its Pharmacovigilance Risk Assessment Committee set to investigate further. However, the regulator said at the time "there is currently no indication that vaccination has caused these conditions," adding that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population. According to the EMA, as of March 9, 22 cases of blood clots had been reported among more than three million people vaccinated in the region.
On Thursday, the Danish Health and Medicines Authority said that the temporary halt to the use of AstraZeneca's product will initially last 14 days as investigations by the EMA are undertaken to determine whether the issues are related to the vaccine. The Health and Medicines Authority noted that one of the cases of blood clots was related to a death in Denmark.
Following this, officials in Norway and Iceland said they would also suspend use of the AstraZeneca vaccine. However, the health ministries of Denmark and Norway reiterated that there was good evidence that the vaccine was safe and effective. The Danish Health and Medicines Authority indicated that a permanent suspension of AstraZeneca's vaccine would push back its immunisation programme by about four weeks.
Commenting on the news, an AstraZeneca spokesperson said the safety of the vaccine had been "extensively studied" and that it was "generally well tolerated." Meanwhile, Phil Bryan, vaccines safety lead for the UK's Medicines and Healthcare Products Regulatory Agency, remarked "the Danish authorities' action to temporarily suspend use of the vaccine is precautionary whilst they investigate. Blood clots can occur naturally and are not uncommon." Bryan added that amongst the more than 11 million doses of AstraZeneca's vaccine administered in the UK, "reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population."
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