Hahn Pledges FDA Independence While Maintaining Role On Warp Speed
FDA Commissioner Stephen Hahn will participate in discussions or considerations of Operation Warp Speed, but won’t be involved in specific decisions or recommendations of the COVID-19 countermeasures public-private partnership to preserve agency independence, he said. The approach is less black and white than other agency officials, but may be acceptable given a commissioner’s more limited role in specific product reviews. Still, some worried about lines becoming blurred.
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Vaccine developers worry that the focus on development speed may embolden anti-vaccine movement and hurt public willingness to get a COVID-19 shot if one is approved.
An official announcement is expected within weeks, as competition between US and China stokes fears of 'vaccine nationalism'.
US FDA Commissioner Hahn says agency's choice to make fast decisions on less robust data sets during COVID-19, paired with constantly reevaluating these decisions drives best public health outcomes. But critics argue the agency may be pushing the bar too low and needs to be more transparent about the evidence it is using for emergency use authorizations.