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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 identified for COVID-19 that can be used as a surrogate...

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