However, the European Medicines Agency (EMA) and the UK’s regulatory body have said that there is no indication that vaccination is linked to thromboembolic events.
Seven other countries—Norway, Iceland, Austria, Estonia, Lithuania, Luxembourg, and Latvia—have also suspended use of AstraZeneca’s vaccine.
The decisions are a further setback for Europe’s vaccination campaign, which has struggled to pick up speed, partly because of delays in delivering the AstraZeneca vaccine.The Danish Health Authority said that one person in Denmark had died after receiving the AstraZeneca vaccine and that it would suspend the drug’s use for two weeks while the case was investigated.
“It is important to point out that we have not terminated the use of the AstraZeneca vaccine—we are just pausing its use,” said the Danish Health Authority’s director, Soren Brostrøm.Phil Bryan, vaccines safety lead for the UK’s Medicines and Healthcare Products Regulatory Agency, said, “More than 11 million doses of the 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.” He added that the agency was keeping the issue under close review but that available evidence did not confirm that the vaccine was the cause.
A spokesperson for AstraZeneca said, “Patient safety is the highest priority for AstraZeneca. Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes Covid-19 Vaccine AstraZeneca.
The safety of the vaccine has been extensively studied in phase III clinical trials, and peer reviewed data confirms the vaccine has been generally well tolerated.”Commenting on the decisions, Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said, “The problem with spontaneous reports of suspected adverse reactions to a vaccine [is] the enormous difficulty of distinguishing a causal effect from a coincidence.”
He highlighted that covid-19 disease was very strongly associated with blood clotting and that there had been hundreds, if not many thousands, of deaths caused by blood clotting as a result of covid-19.
Adam Finn, professor of paediatrics at the University of Bristol, said, “The position with the Oxford-AstraZeneca vaccine at the moment is that there is no sign anywhere, including the UK where very large numbers of doses have now been given, that blood clot related illnesses are happening any more frequently than usual.
“That’s reassuring, because it means either that the vaccine doesn’t cause blood clots at all or, at the very worst, that it’s an extremely rare event.”