
EMA Publishes Risk Management Guidance for COVID-19 Vaccines
The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.
The European Medicines Agency (EMA)
The new guidance provides considerations on vaccines safety in special populations such as the elderly, children, or patients with co-morbidities. It also provides core requirements for lists of adverse events of special interests, methods used for signal detection, and follow-up of safety signals found during clinical trials. The guidance states that monthly summary safety reports must be submitted to EMA in addition to periodic safety update reports. The guidance also discusses traceability tools to record who has received which vaccines from which batch.
“All activities that companies include in the RMP for a COVID-19 vaccine should take into account EMA’s infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice,” the agency stated in a press release.
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