Latest From Sarah Karlin-Smith
FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.
Ahead of the vaccine advisory committee, requests to FDA range from public health groups opposing emergency use authorizations to industry seeking labeling guidance on EUA products.
US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.
The common ‘test-negative’ case-control design may have difficulty evaluating COVID vaccines’ real-world performance because of the limited diagnostic capabilities during the pandemic. In a JAMA editorial, Three members of CDC’s Advisory Committee on Immunization Practices push for US FDA guidance to harmonize safety endpoints and protocols to improve the monitoring of COVID-19 vaccines in both post-market trials and pharmacovigilance systems.
Meetings have long been touted as a tool to boost public confidence in COVID vaccines, but those looking for clean-cut answers may be unsettled to learn about the unknowns that come with all drug development, particularly that done at speed. Advisors are there to offer an ‘unvarnished’ view, committee member Paul Offit says in an interview with the Pink Sheet in advance of the the VBRAC’s 22 October meeting.
Pink Sheet reporters and editor discuss the future of coronavirus products with an emergency use authorization, potential pandemic-inspired regulatory changes at the FDA, and preview the agency’s upcoming advisory committee meeting on coronavirus vaccines.