Steve April 13, 2021

Johnson & Johnson says it is delaying the rollout of its coronavirus vaccine in Europe amid a U.S. probe into rare blood clots

April 13, 2021, 2:55 PM

4 min read

BERLIN — Johnson & Johnson said Tuesday it is delaying the rollout of its coronavirus vaccine in Europe amid a U.S. probe into reports of rare blood clots in some recipients.

The announcement came after regulators in the United States said they were recommending a “pause” in administration of the single-dose shot to investigate reports of potentially dangerous blood clots.

“We have been reviewing these cases with European health authorities,”Johnson & Johnson said. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”

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, which are more at risk from serious illness when infected with COVID-19.

The European Medicines Agency, 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.

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots that occurred 6 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; there was one death.

The Amsterdam-based EMA said following the U.S. announcement Tuesday 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 in 2021. Britain ordered 30 million doses of the J& J vaccine, though U.K. regulators have not yet approved its use.

France had expected to receive 200,000 doses of the vaccine this week and was planning to start administering them next week to people aged 55 and over. In total, the country had planned to receive about 8 million doses of the J&J vaccine by the end of June.

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 home-bound 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.”

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 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,” a 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.”


Mike Corder in The Hague, Colleen Barry in Milan and Sylvie Corbet in Paris contributed to this report.

ABC News

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