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EMA Considers How To Verify Potency Of Next-Generation COVID-19 Vaccines

 
• By Vibha Sharma

Companies approaching the European Medicines Agency with their development plans for new COVID-19 vaccines are being asked to consider immunobridging studies if placebo-controlled trials are not feasible.

Covid variant
Development of second-generation COVID-19 vaccines poses new challenges • Source: Alamy

The European Medicines Agency is in talks with drug companies to explain how it would determine the protective efficacy of next-generation of COVID-19 vaccines as placebo-controlled trials are getting more difficult to undertake.

The EMA says it will be asking companies to undertake immunobridging studies until an acceptable “immune marker” of protection is...

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