Spain temporarily suspends use of AstraZeneca vaccine

Spain has followed the lead of Denmark, Norway, Iceland, the Netherlands and Ireland and has temporarily suspended the administration of the Oxford-AstraZeneca Covid-19 vaccine. The move comes after a number of cases of blood clots were reported among people who had received the medication. Germany, France and Italy also halted the use of the inoculation on Monday, opting to wait until the European Medicines Agency (EMA) clarifies whether or not it is related to these thrombotic events. The EMA, meanwhile, continues to investigate the issue and will make a statement on Thursday. In the meantime, it is insisting that the benefits of the vaccine outweigh the risks.

The alarm raised by a series of these cases prompted the change of course by the Spanish Health Ministry, which until now had been a defender of the continued use of the AstraZeneca vaccine despite the move by Denmark and Norway. “At the weekend the risk evaluation changed,” said María Jesús Lamas, the director of the Spanish Medication Agency, on Monday after an urgent meeting of the Inter-Territorial Council of the National Health System (CISNS), which brings together the Health Ministry and the regional healthcare chiefs. “From Saturday to Sunday we were made aware of a case of cerebral venous thrombosis, specifically of the venous sinuses, which developed with a reduction in platelets, which implies irregular coagulation activity. Fortunately, [the patient] is recovering, but that same day we found out about three similar cases in Norway, and Germany had also identified four cases. We decided that this accumulation of cases of this particular and specific thrombosis warranted additional evaluation.”

No medication is 100% safe, but we have to take into account the benefits of vaccinating the population against a disease that we know is killing millions

Soumya Swaminathan, chief scientist at the World Health Organization

In barely a week, part of the vaccination strategy in Europe has been shattered – at least temporarily. It was Austria that first raised the alert last Tuesday after it suspended the administration of a batch of AstraZeneca on the suspicion that it could have caused a pulmonary embolism in one person and the death of another from multiple blood clots after being vaccinated. Two days later, Denmark went a step further and suspended the administration of the vaccine entirely. And since then, there has been a non-stop trickle of countries doing the same.

The EMA and the World Health Organization (WHO) have both insisted that there were very few cases and that no causal link has been established. In fact, until March 10 only 30 cases of blood clots had been reported after nearly five million doses had been administered in the European Union, according to the EMA. Spain was following this line, but the detection of such specific and uncommon thrombosis cases prompted a change of tack and a new evaluation of the risk.

“These are few cases in absolute terms, but given the qualitative importance of each one of them and the fact that in the general population there are very few cases of clotting disorders, we believe it is prudent to stop,” explained Health Minister Carolina Darias on Monday. According to her ministry, among the six million doses administered in the EU, 11 cases of this kind of cerebral venous thrombosis have been detected. Darias said that the vaccination would be halted for two weeks, or until the EMA takes a decision. The minister did not state whether the stoppage would affect Spain’s global objectives – vaccinating 70% of the adult population by the end of the summer – nor whether it would affect those people who have already received a first dose of AstraZeneca. “There is time,” the minister said, in order to arrange the second doses should there be a positive resolution from the EMA, given that the period between the two injections can be between 10 and 12 weeks.

The minister called for calm, and said that for now, any link between the vaccine and blood clots is “tentative” and not causal. In Spain, where five regions temporarily suspended the use of one of the batches of the vaccine being investigated, a total of 939,534 doses of AstraZeneca have been administered.

“The number of thromboembolic events in general among people who have been vaccinated does not appear to be greater than those observed in the general population,” the EMA insisted on Monday in a statement. The European organization, as well as the WHO, has insisted that the benefits of the vaccine outweigh the risks of secondary effects. “The rates in which thrombosis are being produced among those vaccinated are even lower than those among the general population,” said Soumya Swaminathan, chief scientist at the WHO. “No medication is 100% safe, but we have to take into account the benefits of vaccinating the population against a disease that we know is killing millions of people across the world.”

English version by Simon Hunter.