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Sanofi & GSK Win COVID-19 Vaccine Approval In EU Using Immunobridging Trials

New Biosimilar And Generic Drugs Also Get EMA Nod

 
• By Neena Brizmohun

The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.

Covid vaccine vials
The seventh COVID-19 vaccine has now been approved in the EU • Source: Shutterstock

VidPrevtyn Beta, from Sanofi and GSK, has become the first COVID-19 vaccine to win EU marketing approval based on immunobridging trials.

Well-justified and appropriately designed immunobridging studies that compare an investigational vaccine with an approved one “are adequate for authorizing future...

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