US FDA Preparing For Less-Than-Ideal COVID-19 Vaccine Studies
The best vaccine development program would include robust clinical trials, CBER Director Marks says in an interview, but that depends on what’s happening with viral transmission on the ground.
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Move to lower doses could ease manufacturing scale-up burden a bit; first eight volunteers produced antibodies which match or surpass those seen in patients who have recovered from COVID-19 – but big test awaits in Phase III.
As Pfizer begins human trials, CBER’s Marks eyes nine-month target for a vaccine and urges at-risk manufacturing once a candidate reaches Phase III.
Just as COVID-19 work begins to wane, CBER’s Peter Marks expects an influx of gene therapy work as sponsors attempt to salvage clinical trials.