Denmark and Norway have temporarily halted use of the Oxford-AstraZeneca vaccine as a precaution, after Danish reports of some people having blood clots after vaccination and one death.
The EU medicines agency has emphasised there is no indication the vaccine had caused blood clots. It said the number of cases in vaccinated people was no higher than in the general population. Several European countries have now stopped using two batches of the drug.
AstraZeneca said the drug’s safety had been studied extensively in clinical trials. “Patient Safety is the highest priority for AstraZeneca,” a spokesperson said. “Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes Covid-19 Vaccine AstraZeneca.” Peer-reviewed data confirmed it had been “generally well tolerated”, the statement added.
The series of moves across Europe has come as a setback for a European vaccination campaign that has stuttered into life, partly due to delays in delivery of the AstraZeneca drug. In a separate move, the EU medicines agency has approved the single-dose Johnson & Johnson vaccine, the fourth in the EU.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) said there was no evidence the vaccine had caused problems, and people should still go and get vaccinated when asked to do so. “Blood clots can occur naturally and are not uncommon. More than 11 million doses of the Covid-19 AstraZeneca vaccine have now been administered across the UK,” said Phil Bryan of the MHRA.
Austria suspended use of a particular batch of the drug this week when a woman died 10 days after vaccination because of “severe blood coagulation problems”. The Austrian doses were part of a batch of one million doses, identified as ABV5300, sent to 17 European countries. Estonia, Latvia, Lithuania and Luxemburg have also stopped using doses from that batch.
The EU medicines agency said its safety committee was reviewing the Austrian case, but made clear that “there is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine”.