Europe Reviewed COVID-19 Vaccine Safety Signals

The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) met on May 3, 2021, reviewing safety signals related to COVID-19 vaccines.

The EMA authorizes four COVID-19 vaccines for use in the EU: Comirnaty, COVID-19 Vaccine Moderna, Vaxzevria (previously COVID-19 Vaccine AstraZeneca), and COVID-19 Vaccine Janssen.

On May 7, 2021, PRAC stated, 'the evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.' These risks are identified on this EMA webpage.

Separately, the World Health Organization (WHO) announced on May 7, 2021, the Sinopharm COVID-19 vaccine had been listed for emergency use.

WHO’s Emergency Use Listing is a prerequisite for the COVAX Facility vaccine supply. It also empowers countries worldwide to expedite their own regulatory approval to import and administer Listed COVID-19 vaccines.