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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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More from Geography

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.