Germany, Spain, Ireland, and France, among other EU countries, have decided to temporarily suspend the AstraZeneca COVID-19 vaccine amid reports of serious cases of blood clots.
Several European countries have temporarily suspended AstraZeneca’s vaccine for COVID-19 due to reports of patients having severe blood clots, though the pharmaceutical company pointed to a lack of evidence for the claim.1
The suspension was passed in Germany, Italy, Spain, Ireland and France, among others, as a precautionary measure while waiting for the European Medicines Agency to determine whether the vaccines were the cause of the recent blood-clotting incidents.2
A news release from AstraZeneca reassured that the number of cases of blood clots is far lower than expected. And, according to clinical data, “even though the number of thrombotic events was small, these were lower in the vaccinated group,” the corporation reported.3
“Around 17 million in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” said Ann Taylor, chief medical officer at AstraZeneca.3
AstraZeneca reported 37 cases of blood clots: 15 cases of deep vein thrombosis, and 22 cases of pulmonary embolisms.3
The World Health Organization (WHO) offered a statement asserting that whether or not the events were caused by the vaccine cannot be determined. They also agreed that the rate of blood clots has not exceeded that of the general population.1
It is expected that AstraZeneca will submit an emergency use authorization request to the FDA in the coming weeks. The results of clinical trials for the vaccine reported it to be 70% effective overall.
Safety continues to be prioritized amid the vaccine rollout. According to WHO, of the 300 million COVID-19 shots given globally, no cases of death have been reported to be due to a vaccine.
“The nature of the pandemic has led to increased attention in individual cases, and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” Taylor said.