By Marine Strauss
BRUSSELS (Reuters) – Belgium stated on Wednesday it was suspending vaccinations with Johnson & Johnson (NYSE:)’s Janssen COVID-19 vaccine for folks under the age of 41 following the first death in Europe from extreme side-effects related to 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 well being minister and 7 regional counterparts stated in a press release.
The EMA, the European Union’s medicines regulator, stated it was reviewing the “first fatal report” of a 37 12 months outdated lady in Belgium who had suffered from a blood clot with low platelets, a situation beforehand related to the shot.
It added it had requested the U.S. drugmaker to hold out a sequence of extra research to evaluate a attainable hyperlink between the shot and the uncommon clotting situation.
J&J stated product security was its paramount concern and that the EMA had left it to EU member states to resolve on vaccine use, taking into consideration how briskly the virus was spreading and whether or not different vaccines had been obtainable.
“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 corporate stated in a press release.
The lady died on May 21 after being admitted to hospital with extreme thrombosis and platelet deficiency, the ministry’s assertion stated.
She was vaccinated by way of her employer, outdoors of the official Belgian vaccination marketing campaign.
Belgium has to date administered about 40,000 J&J photographs, with 80% of these to folks over 45 years outdated, the assertion stated.
The EMA stated greater than 1.34 million J&J doses had been administered throughout the EU.
J&J stated on April 20 it will resume rolling out its COVID-19 vaccine in Europe with a warning on its label, after requesting international locations, together with Belgium, to pause its use amid issues about attainable hyperlinks to uncommon blood clots.
J&J has stated that no clear causal relationship has been established between the vaccine and the clots.
Last month, the EMA discovered a attainable hyperlink between the vaccine and uncommon blood clotting points in adults who obtained doses within the United States, however backed its general advantages in opposition to any dangers.
It seemed into eight identified circumstances of clotting together with low platelet counts in individuals who acquired the J&J shot within the United States. All folks affected had been beneath 60 years of age, and most had been girls.
The Janssen one-dose vaccine is primarily utilized in Belgium for house vaccination of the aged and quite a few susceptible teams together with the homeless and undocumented migrants.
Most EU international locations are utilizing the J&J shot, though Denmark has excluded it from its vaccination programme and Italy has restricted its use to older folks.
The United States resumed utilizing the shot in April after a 10-day pause to analyze its hyperlink to the extraordinarily uncommon, however doubtlessly deadly, blood clots.
Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) stated it discovered a “plausible causal association” after figuring out 28 circumstances among the many greater than 8.7 million individuals who had obtained the J&J vaccine.