EMA Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU
A Pharmacovigilance Medical Writer from ICRC-Weyer attended the public meeting hosted by the European Medicines Agency (#EMA) last Friday, the 26th of March. The public meeting provided an update on the approval, safety monitoring and impact of #COVID-19 vaccines in the European Union (EU) and ongoing work to address new COVID-19 variants.
Currently, 4 COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer, Janssen and Moderna have been authorised in the EU. All 4 vaccines have shown a positive benefit-risk balance in the prevention of COVID-19 disease and a good safety profile. The most common side-effects are mild or moderate and temporary and include pain and tenderness at the injection site, headache, tiredness, muscle pain, a general feeling of being unwell, chills, fever, joint pain and nausea.
Very rare but severe allergic reactions have occurred in people receiving the COVID-19 vaccine (in less than 1 in 100,000 people). Very rare events of severe thrombosis combined with thrombocytopenia have occurred after AstraZeneca vaccination (in approximately 1 in one million people), and these events are the topic of current investigations.
The EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee (#PRAC), concluded a preliminary review of cases of blood clots occurring after #AstraZeneca vaccination. This preliminary review confirmed that the vaccine is not associated with an increase in the overall risk of blood clots and that the benefits of the vaccine in combating the still widespread threat of COVID-19 continue to outweigh the risk of side-effects. Updated recommendations are expected at PRAC’s April plenary meeting (6–9 April).
You can view the recorded meeting and download the speakers’ presentations here:
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