EU agency clears use of J&J shot
Warning label about clots is recommended
European regulators said on Tuesday the coronavirus vaccine made by Johnson & Johnson should carry a warning about rare blood clots, but they placed no restrictions on the use of the vaccine in the European Union.
The decision by the European Medicines Agency was based on the same U.S. data that led American regulators last week to pause the use of the vaccine inside the United States.
Johnson & Johnson said after Tuesday’s announcement that it would resume distribution in Europe. But the U.S. hold remains in place as American authorities make an independent evaluation. New guidance is expected as early as Friday.
The European regulators said Tuesday that unusual blood clots with low blood platelets should be listed on the packaging of the vaccine as “very rare side effects,” but they took no further action. The regulators assessed that, overall, the vaccine is safe and effective.
“The benefits of the vaccine continue to outweigh these risks, and we now have detailed information in the labeling that alerts to these risks,” said Emer Cooke, the head of the European Medicines Agency.
“We’re confident that it can be rolled out appropriately,” he said.
Nearly 7 million shots of the Johnson & Johnson vaccine had been administered in the United States before the pause.
Public health officials especially appreciated that the inoculation involves just a single dose, making it easier to give to vulnerable and underserved populations for whom a follow-up appointment for a second shot could be difficult.