EU Mandates Monthly Safety Summaries For Approved COVID-19 Vaccines
EU regulators have agreed on supplementary pharmacovigilance requirements applicable to COVID-19 vaccines following approval.
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Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.
The European Medicines Agency has finalized infrastructure to monitor the safety and effectiveness of COVID-19 medicines and vaccines when they are used in day-to-day clinical practice following marketing authorization.
An EU guideline on the methodological aspects of pharmacoepidemiology has been updated to promote collaboration by researchers on high-quality, multi-centre observational studies in the context of COVID-19.