Coronavirus Notebook: Janssen Vaccine Effective Against Two Virus Variants In South Africa Study, But Gets EU Thrombocytopenia Warning
Data show that more than 480 million COVID-19 vaccines have now been administered in the EU/European Economic Area, with Malta, Iceland and Ireland leading the way in the percentage of people now fully vaccinated.
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Coronavirus Notebook: Richer Countries Urged To Pay ‘Fair Share’ Of Vaccine & Drug Financing, EU Assesses Comirnaty Boosters
EFPIA has welcomed an evidence-based report on the regulatory flexibilities used in Europe during the pandemic and how they could be further employed in future. The EMA’s drug safety committee is looking at more reports of menstrual disorders with mRNA vaccines.
All four coronavirus vaccines authorized for marketing in the EU/European Economic Area have had their safety information updated because of various adverse events including myocarditis, pericarditis and capillary leak syndrome.
New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.