EU Regulators Call for Warning on J&J COVID-19 Vaccine

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

The European Medicines Agency said on Tuesday that the Johnson & Johnson COVID-19 vaccine should come with a warning about the rare risk for thrombosis with thrombocytopenia, finding a "possible link" between the vaccine and the blood clots. The EMA emphasized, however, that the benefits of the vaccine outweigh any potential risks.

The agency called for the warning after eight cases of rare thromboses (e.g., cerebral venous sinus thrombosis, splanchnic vein thrombosis) in combination with thrombocytopenia were identified in the U.S. This is similar to the safety signal observed with AstraZeneca's COVID-19 vaccine.

The Johnson & Johnson vaccine was authorized for use in Europe on March 11. The company paused the launch of the vaccine amid the adverse event investigation, but said on Tuesday that it would resume the rollout.

The CDC's Advisory Committee on Immunization Practices recommended a pause on the Johnson & Johnson vaccine last week. They will take up the issue again during a meeting on Friday.