Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021

PRAC conclusion on very rare cases of unusual blood clots with low blood platelets with Vaxzevria (AstraZeneca’s COVID-19 vaccine)

EMA’s safety committee (PRAC) has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (previously COVID-19 Vaccine AstraZeneca).

In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.

EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of blood clots combined with low levels of blood platelets occurring very rarely within 2 weeks of vaccination…