Europe’s drug regulator has found a possible link between Johnson & Johnson’s COVID-19 vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.
The European Medicines Agency (EMA) said on Tuesday its safety committee had concluded that a warning about unusual blood clots with low platelets must be added to the vaccine’s labels, just as it has also required of rival vaccine maker AstraZeneca.
The findings are a blow to the European Union, which is battling major hurdles to its immunisation campaign after several nations suspended or limited the use of AstraZeneca’s vaccine over possible blood clots. (https://bit.ly/3xckNFu)
The EMA found that all instances of clotting had occurred in adults under 60 years, mostly women, within three weeks of vaccination with J&J’s single shot.
It said all available evidence, including eight U.S. reports of cases, had formed part of its assessment.
The watchdog also said that most clots had occurred in the brain and abdomen, as was the case with AstraZeneca’s shot, Vaxzevria, which is also being studied for similar blood clotting problems.