Moderna’s Early Data On COVID-19 Vaccine Prompts Dosing Revisions For Phase II
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.
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A successful COVID-19 vaccine candidate will create a critical challenge: who receives the first doses of what is bound to be a constrained supply? Vaccine developers see useful lessons from the 2009 H1N1 outbreak – but a very different priority order.
FDA’s Peter Marks and Janet Woodcock will be on the bridge for Operation Warp Speed; Moncef Slaoui says early clinical data on one vaccine candidate makes him confident that a few hundred million doses of a vaccine can be available by the end of the year.
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.