September 30, 2020
With multiple COVID vaccine candidates in late-stage trials, the growing politicization of the process, and, especially the growing concerns and mistrust, now is a particularly important time to engage in the regulatory process. Detailed guidance for COVID vaccine developers, issued by US FDA in June, provides a roadmap for advocates to monitor and evaluate the vaccine approval process, and AVAC recently put out this primer on the process, highlighting the upcoming VRBPAC meeting on October 22.
Please join AVAC and TAG on Wednesday, Sept 30th at 5pm ET for a strategy call to prepare for the October 22 FDA Vaccine Advisory Committee meeting. Access the call here.
We’ll be joined by Josh Sharfstein – now at Johns Hopkins and a former Principal Deputy Commissioner of the FDA – who will walk is through the FDA process, engage in discussion about how best to engage with the VRBPAC process, and provide thoughts on what we all might prioritize and highlight. Written submissions to the FDA are due on Oct 15 and requests to present at the meeting are due on Oct 7.