RE: SCLP25 May 2021 14:57
;But if vaccines can’t be assessed through placebo-controlled trials in future, how can we know if they are effective?
“CEPI set up its centralised lab network back in October to address this very challenge”, explains Valentina Bernasconi, Preclinical and Immunology Scientist in CEPI’s Vaccine R&D Team and Project Leader of the Centralised Laboratory Network. “Our network of labs—which is open to all COVID-19 developers—will help to harmonise evaluation of the immune responses generated by multiple COVID-19 vaccine candidates. This will help researchers establish reliable markers of immunity, like how high antibody levels need to be to neutralise Sars-CoV-2, which will help regulators assess the efficacy of various vaccine candidates in the absence of data from placebo-controlled trials.”
Establishing these blood markers, in particular, could help researchers collect the data needed for regulatory review of next-wave vaccine candidates or existing vaccines that might be tweaked in response to the emergence of new virus variants.
CEPI is working with regulators, researchers, and manufacturers around the world to determine what immunological data will be necessary for regulatory review of future COVID-19 vaccine candidates.'