On Apr. 20, 2021, Johnson & Johnson announced that the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee had provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive.

The guidance followed PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine.