J&J Janssen COVID-19 Vaccine Under Review in Europe

The European Medicines Agency (EMA) safety committee (PRAC) announced on April 9, 2021, it has started a review of a safety signal to assess reports of thromboembolic events (formation of blood clots, resulting in the obstruction of a vessel) in people who received COVID-19 Vaccine Janssen.

The PRAC reported 'four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with COVID-19 Vaccine Janssen. One case occurred in a clinical trial, and three cases occurred during the vaccine rollout in the USA. One of them was fatal.'

These reports point to a ‘safety signal,’ but it is currently unclear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions. PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.

The COVID-19 Vaccine Janssen is currently only used in the USA, under an emergency use authorization.

COVID-19 Vaccine Janssen was authorized in the EU on March 11, 2021. The vaccine rollout has not started yet in any EU Member State but is expected in the next few weeks, stated the EMA.