October, no surprise: COVID-19 vax AdComm booked for the 22nd

Regulatory NewsRegulatory News | 27 August 2020 |  By 

The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at that meeting.
The announcement via the Federal Register and the FDA’s Twitter account comes a day after the head of the key US vaccine research accelerator Operation Warp Speed (OWS) signaled that a COVID-19 vaccine might be authorized or approved by the end of 2020. Both OWS and FDA communications emphasized a continuing commitment to relying on data in vaccine decisions, despite political pressure and medical need for vaccine approval.
A link to the public meeting announcement was posted by the FDA Twitter account on 27 August with a comment that “we will be as open and transparent as possible about our review of a #COVID19 vaccine. Science alone drives the agency’s regulatory decision-making.” The meeting was announced officially in the Federal Register on the same day.  
No agenda was available at press time; however, the meeting announcement notes that the advisory committee will meet in open session “to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.” The announcement clarifies that “No specific application will be discussed at this meeting.”
The previous day, FDA commissioner Stephen Hahn, MD, tweeting under his official @SteveFDA handle, said that “We are already starting to think about the meeting of our vaccine advisory committee on Oct 22.”
Hahn began the Twitter thread by noting that “FDA scientific reviewers who have long experience with vaccine development are encouraged by the rapid rate of enrollment in the ongoing clinical trials for a #COVID19 vaccine.” He acknowledged the need for public trust in the agency and its decision-making, adding that “FDA scientists will judge vaccine safety and effectiveness solely on the basis of good scientific data.”
Earlier this month, Hahn spoke at a virtual meeting held by the Reagan-Udall Foundation, emphasizing that vaccine and therapeutics decisions made by the agency will be “based on good science and sound data.”

“Nothing else will be used” to guide FDA’s decision-making, Hahn said at the time. ““Because of the speed with which we need to make decisions, there has been discussion about whether FDA will compromise any of our scientific principles in reviewing data and making decisions about new products,” he said. “Let me assure you that we will not cut corners.” (RELATED: Hahn: COVID-19 vaccine decision will be "deliberative", Regulatory Focus 11 August 2020)
Moncef Slaoui, PhD, head of OWS, laid out the project’s strategy and approach in a Perspective piece published 26 August in the New England Journal of Medicine. Sloaui and his coauthor, OWS’s Matthew Hepburn, MD, noted that in order to participate in the accelerator, “candidates had to have the potential, with our acceleration support, to enter large Phase 3 field efficacy trials this summer or fall (July to November 2020) and, assuming continued active transmission of the virus, to deliver efficacy outcomes by the end of 2020 or the first half of 2021.”
The authors continued, “The FDA recently reissued guidance and standards that will be used to assess each vaccine for a Biologics License Application (BLA). Alternatively, the agency could decide to issue an Emergency Use Authorization to permit vaccine administration before all BLA procedures are completed.” In his speech at the Reagan-Udall Foundation, Hahn had also indicated that either the BLA or EUA pathway could be appropriate for a COVID-19 vaccine approval.
Regarding the thinking of OWS for a timeline for vaccine authorization or approval, Slaoui said, “No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices we’ve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor.”
At press time, FDA had not responded to a request for more information.


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