European regulator finds link between Janssen COVID vaccine and 'very rare' blood clots

The European medicines watchdog says blood clots should be listed as 'very rare' side effects for the Johnson & Johnson COVID-19 vaccine but insists the benefits outweigh the risks

Blood clots should be listed as a “very rare” side effect of the Johnson & Johnson single dose COVID-19 vaccine, the European Medicines Agency (EMA) said this afternoon.

Last week Johnson & Johnson suspended its EU rollout over reports of rare blood clotting witnessed in the US.

EMA said eight serious cases of unusual blood clots were reported in the US, one of which had a fatal outcome. So far seven million people have received the Johnson & Johnson (Janssen) vaccine in the US.

This follows similar cases of rare blood clots that developed in the wake of people being administered the AstraZeneca vaccine, which prompted curbs to its use in some European countries.

EMA said the blood clots occurred mainly at unsual sites such as in the veins in the brain, the abdomen and in the arteries, together with low levels of blood platelets and sometimes bleeding.

The agency said people who receive the vaccine should be made aware of the possibility of very are cases of blood clots combined with low levels of blood platelets occurring within three weeks of the vaccination.

EMA said due to the fact that the side effect was rare, the vaccine’s effectiveness in combating COVID-19 outweighed the risks of side effects.

“One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin-induced thrombocytopenia, HIT,” the agency said.

Malta had received a consignment of the Janssen vaccine just before the rollout in the EU was suspended by the company. It remains unclear whether this batch will be used as yet.