EMA’s safety committee (PRAC) met, Wednesday 31 March, in the context of its ongoing review of very rare cases of unusual blood clots associated with low numbers of platelets, in people vaccinated with AstraZeneca’s COVID-19 vaccine (now called Vaxzevria).

EMA convened an ad hoc expert group meeting on Monday 29 March to provide further input into the ongoing assessment. The outcome of this meeting will be discussed by the PRAC and feed into its ongoing evaluation.

At present the review has not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events. A causal link with the vaccine is not proven, but is possible and further analysis is continuing.

As communicated on 18 March, EMA is of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.

More information and advice for healthcare professionals and the public is available in the vaccine’s product information and the associated direct healthcare professional communication.

EMA continues to work with the national authorities in the EU Member States to ensure that suspected cases of unusual blood clots are reported; these cases are being analysed in PRAC’s ongoing assessment.