By Marine Strauss
BRUSSELS (Reuters) - Belgium said on Wednesday it was suspending vaccinations with Johnson & Johnson (NYSE:JNJ)'s Janssen COVID-19 vaccine for people under the age of 41 following the first death in Europe from severe side-effects associated with 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 (European Medicines Agency)," Belgium's health minister and seven regional counterparts said in a statement.
The EMA, the European Union's medicines regulator, said it was reviewing the "first fatal report" of a 37 year old woman in Belgium who had suffered from a blood clot with low platelets, a condition previously associated with the shot.
It added it had asked the U.S. drugmaker to carry out a series of additional studies to assess a possible link between the shot and the rare clotting condition.
J&J said product safety was its paramount concern and that the EMA had left it to EU member states to decide on vaccine use, taking into account how fast the virus was spreading and whether alternative vaccines were available.
"As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere," the company said in a statement.
The woman died on May 21 after being admitted to hospital with severe thrombosis and platelet deficiency, the ministry's 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% of those to people over 45 years old, the statement said.
The EMA said more than 1.34 million J&J doses had been administered within the EU.
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 vaccine and 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.
Most EU countries are using the J&J shot, although Denmark has excluded it from its vaccination programme 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 the extremely rare, but potentially lethal, blood clots.
Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) said it found a "plausible causal association" after identifying 28 cases among the more than 8.7 million people who had received the J&J vaccine.