Germany, France and Italy are suspending use of AstraZeneca‘s coronavirus vaccine amid concern over reports of blood clots linked to the jab, despite assurances from the drugmaker that there is no link with coagulation disorders.
The three countries said the move was taken pending an assessment by the European Union’s medicine regulator, which is due to issue guidance on Tuesday.
Spain’s prime minister, Pedro Sanchez, has said Madrid would provide an update on the matter later on Monday.
Germany’s health ministry said the decision was taken as a “precaution” and on the advice of Germany’s national vaccine regulator, the Paul Ehrlich Institute, which called for further investigation of the cases.
A spokesman for Germany’s Federal Ministry of Health said the European Medicines Agency (EMA) would decide “whether and how the new information will affect the authorisation of the vaccine”.
“The decision which has been taken out of precaution is to suspend vaccinating with the AstraZeneca vaccine in the hope that we can resume quickly if the EMA gives the green light,” Emmanuel Macron told a press conference. “We are therefore suspending its use until tomorrow afternoon.”
The Italian medicines authority AIFA also confirmed it was taking the decision as a “precautionary and temporary measure”.
Italy’s decision to suspend use of the vaccine was made after a discussion between the country’s prime minister, Mario Draghi, and health minister, Roberto Speranza.
“[Mr] Speranza held talks with the health ministers of Germany, France and Spain during the day,” the health ministry statement said.
The decision follows similar moves by the Netherlands and Ireland in the last 24 hours to allow time to investigate cases of blood clots that occurred after vaccination.
But the overwhelming scientific opinion remains that there is no certain link between blood clots and the vaccine, and the reported cases could easily be coincidental.
The head of Oxford University’s vaccine group, Andrew Pollard, said there was “very reassuring evidence that there is no increase in a blood clot phenomenon here in the UK, where most of the doses in Europe have been given so far”.
AstraZeneca said a review of safety data from more than 17 million people vaccinated in the EU and UK had shown “no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country”.
Until earlier this month Germany had restricted the AstraZeneca jab to people aged under 65 because of what it said was limited evidence to prove its efficacy in older cohorts.
On 4 March Germany’s vaccination committee reversed that guidance, opening the vaccine up to most of its adult population.
Norway, Iceland, Bulgaria, Ireland and the Netherlands have also opted to halt the rollout of all doses produced by the Anglo-Swedish pharmaceutical company.
Austria, Estonia, Latvia, Lithuania and Luxembourg have suspended the use of a certain AstraZeneca batch, while Italy and Romania stopped the use of another batch.
