Safety Review of Janssen COVID-19 Vaccine Continues in Europe

EMA's Pharmacovigilance Risk Assessment Committee is reviewing very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is continuing its review of very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.

According to an April 14, 2021 press release, as a result of six reported cases in the US of cerebral venous sinus thrombosis (CVST), which mostly occurred in instances where there were low levels of blood platelets (thrombocytopenia), Janssen has decided to delay the European rollout of its vaccine while investigations are performed. Janssen’s vaccine was authorized for use in the European Union (EU) on March 11, 2021, but widespread use of the vaccine has not yet started in the region.

EMA is working with the US FDA and other international regulators on the matter and will decide on whether regulatory action is necessary. The evaluation of all reported cases is being expedited and EMA expects recommendation on the matter to be issued within a seven-day period.

While the review is ongoing, EMA maintains that the benefits of the vaccine outweigh the risks of side effects.

Source: EMA