BERLIN — Johnson & Johnson says it is delaying the rollout of its coronavirus vaccine in Europe amid a U.S. probe into rare blood clots.
The company announced the decision Tuesday 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,” the company said. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”
Hundreds of thousands of doses of the vaccine were due to be shipped to Europe in the coming weeks.
U.S. pauses use of Johnson & Johnson vaccine
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts. More than 6.8 million doses of the J&J vaccine have been administered in the U.S.
U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.
CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation of the cases.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a joint statement.
Canada was set to received its first shipments of Johnson & Johnson’s one-dose vaccine at the end of April.
There’s been no word so far from Health Canada on whether it intends to pause use of the shot in light of the suspension in the U.S.
On this side of the border, the AstraZeneca vaccine is the only one that’s been flagged, after reports of rare blood clots were associated to that drug.
Canada’s National Advisory Committee on Immunization (NACI) recently recommended a pause on AstraZeneca vaccinations for people under 55 due to safety reasons. The panel said adults 55 and older may still be offered the AstraZeneca vaccine with informed consent.
ACI says cases identified have been primarily in women under the age of 55 years but notes cases in men have also been reported and have mostly occurred between four and 16 days after administration.
AstraZeneca updated the efficacy data for its vaccine last month and say the shot is 76 per cent effective against mild symptoms and 100 per cent effective at preventing severe disease from the virus. In trial volunteers aged 65 and older, the vaccine was 85 per cent effective in preventing symptoms.
In addition to the AstraZeneca vaccine, Canada is currently using the ones made by Pfizer-BioNTech and Moderna.