FDA AdComm Agenda Covers the Bases

First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as research into a vaccine is aggressively underway, we also see serious drawbacks. Apart from the increasing numbers of cases in the United States, there has been a strong perception that the process has been politicized which in turn has brought on an increasing skepticism or crisis in confidence on the part of the public to embrace the outcome. And now, three agencies that have seen an erosion in public confidence – FDA, CDC and NIH, will participate in an FDA Advisory Committee meeting that will discuss vaccine development.

The agenda has been posted for the October 22 meeting, and the discussion will be available to view on YouTube, according to FDA Commissioner Hahn. One had to wonder what the meeting would actually be discussing since there was no candidate vaccine to consider for approval and given the fact that FDA has already issued guidance to provide a framework of understanding for how the agency will approach approval.

The order of the day includes presentations from all three stakeholder agencies – CDC, FDA and NIH and appears to be designed to add a little more meat to the bones on how each will play a role and to lay out some of the mechanics of the process. in the day they will establish a level playing field for understanding COVID-19, followed by the various key agencies explaining their part in the process, beginning with NIH, followed by BARDA with CDC discussing that agency’s role in monitoring use after either early use authorizations (EUA) or final licensure and CBER will follow up describing post-marketing surveillance systems. Another CDC presentation will discuss vaccine distribution and tracking, which is an important topic about which there are many questions, followed by a discussion on “vaccine confidence” presented by the Reagan-Udall Foundation. There will be a specific discussion of the manufacturing and control as well as the clinical considerations for EUAs and licensure. In short, broadly all the categories in which there are questions seem to represented in the agenda.

Apparently as well, they are expecting a higher degree of public participation in the Open Public Comment period, usually reserved as a 60-minute window, but which is cast for 90 minutes for Thursday. Presumably if that is the case, participation will be limited to a set number of minutes. The number of comments added to the docket that had been set up for the meeting numbered 34 as of yesterday and included two stakeholder companies engaged in clinical trials.

Hopefully what will come out of the discussion is not only the broad understanding of the background and mechanics of approval and distribution, but answers to a good number of the questions regarding the nuances of actual approval, distribution and uptake. Whatever is going to be offered up during the presentation from the Reagan-Udall Foundation about confidence, this meeting will actually be an important factor related to the confidence levels of people, particularly health care workers, in taking a vaccine once there is one to take. This meeting cannot settle for perfunctory presentations and must take the questions that were raised in the docket comments, and those that will be raised during the Open Public Comment period and respond to them in some way subsequent to the meeting. We are in unprecedented times that require unprecedented transparency, planning and sound communications that has so far been largely lacking. Meetings are often perceived as an event – but this one is the beginning of a process.

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