Spain, France and Germany halt vaccination with AstraZeneca

MadridCases of thrombosis in people recently vaccinated with AstraZeneca's vaccine have led Spain to join other countries that have decided to temporarily suspend the administration of the vaccine developed by Oxford University. The Health Ministry announced yesterday the suspension for two weeks - pending a recommendation by the European Medicines Agency (EMA) - of immunisation with the AstraZeneca vaccine after an urgent meeting of the Interterritorial Council to communicate the "precautionary and temporary" suspension to the autonomous communities. Germany, France and Italy had taken the same decision "as a precaution" hours earlier.

After days of some confusion over the withdrawal of some batches of the vaccine AstraZeneca by the alarm generated by some thirty cases in Europe of thrombosis in people who had been vaccinated, yesterday Spain and the other three European countries decided to act more forcefully. The reason, as explained by the Minister of Health, Carolina Darias, is the appearance over the weekend of new cases of thrombosis which, unlike the previous ones, are a "rare" type among the general population. These cases "triggered the alarms" and caused a change in "the risk assessment".

"Unusual and disabling" headache

This rare condition is a cerebral venous thrombosis that occurs due to a decrease in platelets, according to Darias, "that is out of the known patterns" and has similarities with complications arising from covid-19. The main symptom is a very strong, "unusual" and "disabling" headache. In the general population, without vaccination, the incidence is 1.3 cases per 100,000 inhabitants/year and it is more common in women than in men. The exact causes are not known, but it is a type of thrombosis associated with pregnancy and postpartum, the use of oral contraceptives and autoimmune diseases, among others.

According to the Health Ministry, there are eleven cases of this type of thrombosis among 17 million people vaccinated. One of them has been detected in Spain, although no further details have transcended. Darias only revealed that the affected person is recovering. In Norway, at least three cases have been detected in recent days: one of them is that of a health worker who was hospitalised two days ago and died yesterday. She was a 50-year-old woman with no previous illnesses who had received the vaccine a week ago.

"They are very few cases," said the director of the Spanish Medicines Agency, María Jesús Lamas. "But we think it is prudent" to stop the vaccination "until a risk estimate is made" and it can be determined whether the cases of thrombosis are related to the vaccine. Lamas recalled that the likelihood of adverse effects exists with any drug but that it is "highly unlikely" to happen with the Oxford vaccine. Darias called for calm, as Spanish president Pedro Sánchez had done earlier.

The decision on Thursday

The EMA is scheduled to meet today to analyse all the scientific information on these possible side effects and has also called an extraordinary meeting on March 18 to make a final decision. Even so, yesterday, in an appearance at the European Parliament, the EMA scientist responsible for vaccine strategy, Marco Cavalieri, insisted that at present the data do not show that there are more risks than benefits in the use of the AstraZeneca vaccine and that, therefore, it can continue to be applied. Even so, a new emergency review is being carried out in case it is necessary to advise against its use in certain more vulnerable groups or with pathologies.

The suspension of Spain, France, Germany and Italy are the latest cases in the trickle of casualties and came just hours after the government of the Netherlands also announced the temporary halt of the administration of the vaccine, following suspicions that it could be related to the appearance of clots in some of the people who had received it. Ireland had also announced a halt on Sunday, as had Austria, Denmark, Estonia, Lithuania, Norway, Iceland and Thailand.

The facts are being studied and there is currently no conclusive evidence linking the vaccine to the thrombi, but the new cases join those that had already been detected during the week in Austria, Denmark and Italy, some of which also led to the death of patients. Nevertheless, both the World Health Organization (WHO) and the EMA see no reason to stop using the vaccine and recommend keeping it. Doses of AstraZeneca's vaccine continue to be used normally in many European countries, most notably the United Kingdom, where it has been key to a campaign that has already reached, at least in a first dose, over24.4 million people.

The pharmaceutical company defends itself

AstraZeneca said in a statement that it has analysed the effects of over 17 million doses administered between the UK and the EU and has so far found "no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia [low platelet count]". In fact, it speaks of fewer than about 40 cases of thrombus. "The number of such episodes recorded with AstraZeneca's covid-19 vaccine is not higher than the number that would have occurred naturally in the unvaccinated population," says the pharmaceutical company.

Key moments in the alarm that has shaken Europe for the past ten days

Denmark sounds the alarm and the dominoes fall

On Thursday last week, Denmark, Norway and Iceland suspended vaccination with AstraZeneca. But it was the Danish decision, after a death, that set off the alarm. In addition, four days earlier Austria and Italy had withdrawn two specific batches of the vaccine from the administration process. In Austria a nurse died after being vaccinated.

The World Health Organization and the European Agency are calling for calm

On the same day that Denmark issued the alert, both the World Health Organization (WHO) and the European Medicines Agency (EMA) commented on the information: although all covid vaccines continue to be evaluated as part of the normal process of implementing a new drug, the two agencies do not find a direct link between circulatory problems and the administration of the vaccines. As of March 10, 30 cases of thromboembolic events had been reported among about 5 million people immunised.

Rare type of thrombosis associated with covid

Eleven cases of a rare thrombosis - one of them in Spain - were detected last weekend, raising further alarm. The disease has similarities to complications arising from covid-19. The main symptom is a severe headache. The incidence is 1.3 cases per 100,000 inhabitants. Among the 17 million people already vaccinated with Oxford there have been 11.

Europe's big boys choose to stop AstraZeneca

Another chain reaction occurred yesterday after first Germany, then Italy, which had already withdrawn a batch, then France and finally Spain decided to stop the campaign with the Oxford vaccine. The day before, in fact, both the Netherlands and Ireland had acted similarly

The EMA will decide on Thursday

While the UK continues to administer the Oxford vaccine, claiming it is safe, the European Medicines Agency announces that its safety committee will meet today and that on Thursday, with all the data collected on the table, it will decide whether or not it is advisable to continue the campaign with AstraZeneca.