Latest From Sue Sutter
Operation Warp Speed will hold back initial shipments to ensure two-dose regimens can be completed; 15 December is ‘chalk’ target date for emergency authorization of Pfizer vaccine, OWS’ Gustave Perna says, calling it only a projection that does not impinge on FDA authority. Sending only half shipments also eases burden on cold shortage capacity at state and local level, he says.
COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers
First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.
Although US FDA wants sponsors to maintain blinded Phase III follow-up as long as possible after emergency use authorization or licensure, vaccine researcher Larry Corey says it will become ‘untenable’ to keep individuals in placebo arm once they qualify for vaccine access under the allocation framework.
Industry principles for enhancing diversity in clinical trials call for use of digital data collection tools and flexible scheduling of study site visits to reduce barriers to enrollment, as well as greater involvement of under-represented communities in the trial design planning process and recruitment of investigators with diverse ethnic and racial backrounds.
Use of expedited pathway based on drug’s effect on brain amyloid would be problematic given advisory committee’s views of a disconnect between biomarker data and clinical efficacy results; however, one FDA expert sees potential for agency to grant accelerated approval on basis of an intermediate clinical endpoint – the same endpoint on which Biogen seeks regular approval.
Use of exploratory methods to understand as much as possible from the two Alzheimer’s disease drug trials that were terminated early for futility is the same type of ‘innovative thinking’ that will be needed to salvage information from neuroscience trials interrupted by the COVID-19, US FDA Office of Neuroscience director Billy Dunn says.