Vaccine Experts Inject Realism Into US Gov't's COVID-19 Timeline
The Trump administration says a COVID-19 vaccine could be available in as little as 12 months, but most experts think that is overpromising unless safety or efficacy standards are sacrificed. Many are urging pivotal studies that look at clinical outcomes, not surrogates, for US FDA approval.
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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.
The global COVID-19 pandemic is prompting an unprecedented effort to develop a vaccine in record-breaking time. But there may be pitfalls in letting optimism run too far ahead of the realities of vaccine development.