At A Glance: COVID-19 Vaccines In EU And Great Britain
Same Four Vaccines Approved And Comirnaty Indication Extended In Both Jurisdictions
The EU and UK have approved the same COVID-19 vaccines but the review pathways have not always been the same.
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Thirteen of the 20 new active substances that were approved in the EU between January and April this year have also now received regulatory clearance in Great Britain, Pink Sheet analysis finds. New filing procedures have been in place there since 1 January.
Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.
The filing for Origin Biosciences’ fosdenopterin (Nulibry) is being fast-tracked at the European Medicines Agency. The outcomes of accelerated assessment requests from Janssen and Sanofi for teclistamab and nirsevimab respectively appear not yet to be in the public domain.