Updated 6pm
Germany, France Italy and Spain on Monday halted the use of AstraZeneca's coronavirus vaccine after reported blood clotting incidents in Europe, despite assurances from the vaccine's co-developer that it is safe.
The "precautionary" decision runs counter to recommendations made by the European Union's medicines regulator, which assured member states that it "does not see any problem in continuing with the vaccination campaign using this vaccine."
Regulators in Germany, France Italy and Spain said they were ordering a halt to AstraZeneca vaccinations following reports of thromboses of the cerebral veins in some patients who received the vaccine.
"The decision has been made... to suspend the use of the AstraZeneca vaccine as a precaution, hoping that we can resume it quickly if the judgement of the EMA allows it," French President Emanuel Macron said.
Germany, France, Italy and Spain join a number of other European countries, including Ireland, the Netherlands, Bulgaria and Denmark, which have suspended usage of the shots, which were jointly developed with the University of Oxford.
The decision means tens of thousands of vaccination appointments across these EU member states will have to be put off, adding further strain to vaccine rollout programmes already criticised for their slow speeds.
Why are countries suspending use of the vaccine?
Concerns stem from reports of some patients having suffered blood clots following vaccination.
Reports were first raised in Denmark last week, prompting an investigation into a batch of the jabs. Malta was among the countries to have received doses from that batch, but no adverse affects have been reported.
Incidents appear to be isolated, with the EMA reporting around 30 cases of blood clotting among almost five million people vaccinated with the AstraZeneca shot across the EU as of March 10.
The UK, which has administered several million doses of the vaccine, has said there is no evidence of an increased risk when taking the vaccine.
What has the EU regulator said?
The European Medicines Agency is currently scrutinising data related to the blood clot reports and will meet on Thursday to discuss findings.
But the EMA said on Monday that it currently saw no problem in continuing to use the vaccine, adding that the benefit of administering it to combat COVID-19 outweighed adverse side-effects.
"Many thousands of people develop blood clots annually in the EU for different reasons. The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population," the EMA said on Monday.
The vaccine manufacturer has also said there is no link between their vaccine and blood clotting. The UK and Canadian governments as well as World Health Organisation have also said they currently see no issue with the vaccine.
EU suspicions
It is the second time in two months that member states have acted differently to EMA advice concerning the AstraZeneca vaccine.
In early February, Germany, France and Italy had warned that the vaccine may be ineffective when given to older patients, citing insufficient data. That prompted several other countries to follow their lead in only administering the vaccine to younger cohorts.
But that warning was withdrawn some weeks later, with authorities acknowledging that the vaccine worked in older patients. Malta is currently administering the vaccine to those up to age 70.
Tensions between the pharmaceutical manufacturer and the EU have been high in recent weeks, with AstraZeneca saying last week that it expected to deliver fewer vaccines than originally planned to the EU, due to "export restrictions".
EU internal market commissioner Thierry Breton went public with his displeasure last week, saying he was not seeing “best efforts” from the manufacturer.
"I see efforts, but not ‘best efforts’ — that’s not good enough yet for AstraZeneca to meet its Q1 obligations," Breton said. "It’s time for AstraZeneca’s board to exercise its fiduciary responsibility and now do what it takes to fulfil AZ’s commitments."