As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia).

The US FDA and CDC recommended yesterday that the use of the vaccine should be paused while they review six reported cases in the United States. More than 6.8 million doses of the vaccine have been administered.

Janssen has announced their decision to proactively delay the rollout of the vaccine in the EU while investigations continue. The vaccine was authorised in the EU on 11 March 2021 but widespread use of the vaccine within the EU has not yet started. The company is in contact with national authorities, recommending to store the doses already received until the PRAC issues an expedited recommendation.

EMA is investigating all the cases reported and will decide whether regulatory action is necessary. The Agency is working closely with the US FDA and other international regulators.

EMA is expediting this evaluation and currently expects to issue a recommendation next week. While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects. The Agency’s scientific opinions provide EU Member States with the information they need to take decisions on the use of vaccines in their national vaccination campaigns.

Posted on the EMA website on 14 April 2021