COVID-19 Vaccine Race Will Need To Eliminate Development ‘Dead Space’
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.
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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.
President Trump's Operation Warp Speed initiative aims to have a COVID-19 vaccine available by the end of the year; Slaoui, who helped get the first cervical cancer vaccine to market and win European approval of the first malaria vaccine while at GlaxoSmithKline, is tasked with coordinating the government's contributions to coronavirus vaccine effort and achieving what would be twin scientific and manufacturing miracles.
Pfizer said it is dosing patients now with an mRNA-based vaccine and expects human data in May/June, with a goal to have a vaccine available for emergency use possibly by October.