Belgium said on Wednesday it was suspending vaccinations with Johnson & Johnson’s Janssen COVID-19 vaccine for people under the age of 41 following the death of a woman from severe side effects after she was given the shot.
“The Inter-ministerial conference has decided to temporarily administer Janssen’s vaccine to the general population from the age of 41 years, pending a more detailed benefit-risk analysis by the EMA,” said a statement issued by Belgium’s federal health minister and seven regional counterparts.
EMA is the European Union’s European Medicines Agency. There was no immediate comment from EMA or J&J.
The woman—who was under the age of 40—died on May 21 after being admitted to hospital with severe thrombosis and platelet deficiency, the statement said.
She was vaccinated through her employer, outside of the official Belgian vaccination campaign.
Belgium has so far administered about 40,000 J&J shots, with 80 percent of those to people over 45 years old, the statement said.
J&J said on April 20 it would resume rolling out its COVID-19 vaccine in Europe with a warning on its label, after requesting countries, including Belgium, to pause its use amid concerns about possible links to rare blood clots.
J&J has said that no clear causal relationship has been established between the clots.
Last month, the EMA found a possible link between the vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.
It looked into eight known cases of clotting in combination with low platelet counts in people who got the J&J shot in the United States. All people affected were below 60 years of age, and most were women.
The Janssen one-dose vaccine is primarily used in Belgium for home vaccination of the elderly and a number of vulnerable groups including the homeless and undocumented migrants.
Belgium has asked for advice from the EMA to evaluate the link between the woman’s death and the J&J vaccine.
It did not say when it expected the EMA’s final opinion on it.
Most EU countries are using the J&J shot, although Denmark has excluded it from its vaccination program and Italy has restricted its use to older people.
The United States resumed using the shot in April after a 10-day pause to investigate its link to extremely rare but potentially lethal blood clots.
The authorities there noted that the risks of experiencing the syndrome involving severe blood clots and low platelets as a result of the vaccine was very low.
Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) said it found a “plausible causal association” after identifying 28 cases of rare blood clots accompanied by low platelets among the more than 8.7 million people who had received the J&J vaccine.