EMA’s safety committee – PRAC has recently met to discuss about all aspects of risk management associated with medicine use.
Enhanced safety monitoring in the form of pandemic summary safety reports is one of the commitments required from the marketing authorisation holders in the context of the conditional marketing authorisation. Marketing authorisation holders are required to submit pandemic summary safety reports to EMA monthly. These reports are reviewed by the PRAC and any area of concern further investigated, if needed.
Moreover, PRAC has also finalized its review on COVID-19 Vaccine Janssen and confirmed, as previously communicated, that its benefits outweigh the risks of side effects. PRAC continues to closely review Comirnaty product’s information and COVID-19 Vaccine Moderna for unusual blood clots with low blood platelets.
As part of the review of the regular pandemic summary safety reports for Vaxzevria, AstraZeneca’s Covid-19 vaccine, the PRAC is analysing data provided by the marketing authorisation holder on cases of Guillain-Barre syndrome (GBS) reported following vaccination. GBS is an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking.
More information is available on the EMA website.