CPhI Online

J&J to resume rollout of COVID-19 vaccine in EU after positive EMA safety ruling

21 Apr 2021

Agency’s safety committee concludes positive benefit-risk profile but orders warning about rare blood clots to be added to shot’s product information

Johnson & Johnson said late on Tuesday it will resume the rollout of its single-dose Janssen COVID-19 vaccine in the European Union, Norway and Iceland after the European Medicines Agency’s safety committee confirmed the shot’s overall benefit-risk profile remains positive.

Rollout was temporarily suspended last week after reports of a small number of cases of blood clots in women who took the vaccine were investigated by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

After meeting Tuesday, the PRAC concluded that “a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen” and that these blood clotting events should be listed as very rare side effects of the vaccine.

In a statement, J&J said it will update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet “to include important information on the diagnosis and management of this adverse event.”

The pharma company added that healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as well as the appropriate course of treatment.

The updated EMA and Healthcare Professionals guidance will be available to national healthcare authorities.

“We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment,” said Paul Stoffels, Chief Scientific Officer at Johnson & Johnson.

The US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are still reviewing these same cases. On April 14, 2021, The CDC first convened a meeting of the Advisory Committee on Immunization Practices on April 14 to review the blood clot cases and assess their potential significance. The committee’s next meeting is scheduled for April 23.