Johnson & Johnson has said it is delaying the rollout of its coronavirus vaccine in Europe amid a US probe into rare blood clots.
The company announced the decision on Tuesday after regulators in the United States said they were recommending a “pause” in administration of the single-dose vaccine to investigate reports of potentially dangerous blood clots.
“We have been reviewing these cases with European health authorities,” the company said.
“We have made the decision to proactively delay the rollout of our vaccine in Europe.”
It comes after the US Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued a joint statement saying they were investigating unusual clots in six women that occurred six to 13 days after vaccination.
The clots occurred in veins that drain blood from the brain and occurred together with low platelets.
All six cases were in women between the ages of 18 and 48.
The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another Covid-19 vaccine not yet cleared in the US, from AstraZeneca.
The delay is a further blow to vaccination drives in European Union member nations, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots in a small number of people who received the AstraZeneca vaccine.
The blood clot reports prompted several countries in the 27-nation bloc to limit the AstraZeneca vaccine to older age groups, who are more at risk from serious illness when infected with Covid-19.
The European Medicines Agency (EMA), the EU’s equivalent to the FDA, said last Friday that it was reviewing cases reported in the United States of blood clotting in people who had received the Johnson & Johnson vaccine, which was developed by the company’s Janssen subsidiary.
The Amsterdam-based EMA said following the US announcement on Tuesday that it “is currently not clear whether there is a causal association between vaccination with Covid-19 Vaccine Janssen and these conditions”.
The European agency’s safety committee “is investigating these cases and will decide whether regulatory action may be necessary”, the EMA said in an email to the Associated Press.
The EU ordered 200 million doses of the Johnson & Johnson vaccine in 2021.
Britain ordered 30 million doses of the J& J vaccine, though UK regulators have not yet approved its use.
Officials in Germany, which was due to receive 232,800 doses of the vaccine this week and 10.1 million doses by the end of June, said earlier on Tuesday that there were no immediate plans to change the schedule.
“I don’t currently have the date from which Johnson & Johnson will be administered,” Health Ministry spokesman Hanno Kautz told reporters in Berlin.
“But in principle, we naturally always take such warnings in an international context seriously and investigate them.”
Italy also expected to receive its first Johnson & Johnson deliveries this week.
The Lazio region surrounding Rome planned to give the prison population the single jab, while the northern Veneto region, which includes Venice, planned to use it for housebound adults over 80.
“I am watching today’s news with concern, as a humanitarian actor. I am also watching with satisfaction, because the regulatory system is working,” Francesco Rocca, president of the International Federation of the Red Cross, told foreign reporters in Italy.
“I imagine there will be repercussions, as we are waiting for millions of doses. But this means the controls are working. If we need to be prudent, we need to be prudent.”