The European Medicines Agency said a warning label should be added to the Johnson & Johnson vaccine, but said overall benefits still outweigh risks.
The European Medicines Agency (EMA) said Tuesday it found a “possible link” between the Johnson & Johnson (J&J) COVID vaccine and very rare blood clots, but concluded the vaccine’s benefits still outweigh the risks. EMA’s safety committee (PRAC) said a warning should be added to the product label, but the blood clot-related disorders should be listed as “very rare” side effects of the vaccine.
J&J had delayed the vaccine’s rollout in the EU after concerns about blood clots led U.S. regulators to call for a pause. The company said Tuesday it will resume shipment of the vaccine, distributed under its Janssen subsidiary, in the EU, Norway and Iceland.
In reaching its conclusion, the committee said it took into consideration all currently available evidence including eight reports from the U.S. of serious cases — one of which was fatal — of unusual blood clots. All cases occurred in people under 60, and all occurred within three weeks after vaccination. The majority were women.