Milestones :: Perspectives :: Research
COVID Vaccines – EMA
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
First monthly summary safety report for COVID-19 vaccine Comirnaty
Starting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports submitted monthly by marketing authorisations holders of COVID-19 vaccines. The first such report will be for Comirnaty.
The company is expected to submit their monthly summary safety report in mid-January. The PRAC will evaluate and discuss it during its PRAC plenary virtual meeting at the end of January.
The outcome of the PRAC’s assessment will be communicated on EMA’s website shortly after.
During the pandemic, marketing authorisation holders for COVID-19 vaccines are expected to submit monthly summary safety reports, in line with the risk management plan and as described in the safety monitoring plan for COVID-19 vaccines prepared by EMA and the national competent authorities of the EU Member States. The plan outlines how relevant new information emerging after the authorisation and roll-out of COVID-19 vaccines will be collected and promptly reviewed.
The monthly summary safety report will include, among others, information on reported suspected adverse reactions, including adverse events of special interest (AESIs).
The submission of such reports complements the submission of periodic safety update reports (PSURs)…