LONDON (Reuters) -The European Union’s drug regulator said on Wednesday it is reviewing the death of a woman in Belgium who suffered a blood clot and low platelets after receiving Johnson & Johnson’s COVID-19 vaccine.
The European Medicines Agency (EMA) said it has asked the U.S. drugmaker to carry out a series of additional studies to help assess a possible link between the shot and a known rare but serious clotting condition called thrombosis with thrombocytopenia syndrome (TTS).
It said it is reviewing the case in Belgium along with other reports of blood clots with the Belgian and Slovenian medicines agencies.
EMA said it was the first report of a fatality following use of the J&J vaccine, although there have previously been three deaths associated with the company’s one-dose shot in the United States.
Earlier on Wednesday, Belgium suspended use of J&J’s COVID-19 vaccine for people under the age of 41 following the death of a woman who was admitted to hospital with severe thrombosis and platelet deficiency.
She was reported to be Slovenian, although Reuters was not able to confirm this.
As of May 20, more than 1.34 million doses of J&J’s shot had been administered in the EU, EMA said.
EMA and national authorities will continue to monitor the vaccine’s safety and effectiveness and provide further updates as necessary, it said.
(Reporting by Josephine Mason; Editing by Elaine Hardcastle and Bill Berkrot)