Biotech, academic leaders encourage FDA to consider T-cell assessment in Covid-19 vaccine trials
More than 60 signatories sent a letter to the FDA’s Robert Califf and Peter Marks on Thursday urging the agency to include a recommendation for T-cell assessment in Covid-19 vaccine clinical trials in its guidance to vaccine developers to comprehensively measure immune response more effectively.
Measuring T-cell responses in addition to antibodies is critical to help better evaluate vaccine efficacy and informed decisions regarding protection against current and future variants of the disease, according to the letter.
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