The European Union’s drug regulator on Oct. 1 recommended updating the label for Johnson & Johnson’s COVID-19 vaccine with warnings for two more serious health conditions likely linked with the vaccine.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the use of the J&J vaccine is possibly linked with vein clotting and an immune condition that causes the immune system to attack blood platelets.
“The PRAC has concluded that there is a possible link to rare cases of venous thromboembolism (VTE) with COVID-19 Vaccine Janssen,” the committee meeting highlights stated.
Venous thromboembolism “is a condition in which a blood clot forms in a deep vein, usually in a leg, arm, or groin, and may travel to the lungs causing a blockage of the blood supply, with possible life-threatening consequences,” the committee said.
Janssen, a J&J company, did not respond to a request for comment.
After reviewing new evidence, PRAC concluded that there is a “reasonable possibility” that the clotting condition is linked with vaccination using the J&J vaccine. The committee recommended listing venous thromboembolism as a rare side effect in the product information for the J&J vaccine.
The committee also found that the use of the J&J and the AstraZeneca vaccines is linked to an immune condition that causes the body’s immune system to target healthy platelets needed for normal blood clotting.