EMA Considers How To Verify Potency Of Next-Generation COVID-19 Vaccines
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.
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Five vaccines and six therapeutics are now available for use against COVID-19 in the EU, but as Omicron shows, there is likely to be a need for new kinds of vaccines against future virus variants.
Drug regulators from five countries have outlined their joint expectations on the data companies must submit for the approval of next-generation COVID-19 vaccines if they opt for immunobridging studies instead of large-scale efficacy trials.
Cellular responses and other potential immune correlates of protection could be better measurements of efficacy, Janssen’s vaccine discovery head argues at BIO.