FDA23 Jun 2020 16:52
In a letter dated June 18, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairman of the committee’s Subcommittee on Economic and Consumer Policy, along with Rep. James Clyburn (D-SC), chairman of the Select Subcommittee on the Coronavirus Crisis, offered suggestions as to how Hahn could improve public confidence in any Covid-19 vaccines his agency might authorize. They also invited the commissioner to brief their staff on the topic on July 2.
Francis Collins NIH
Specifically, the lawmakers advocated for basing any approval on Phase 3 trials with at least 30,000 participants, a threshold the lawmakers expressed confidence in as it was proffered as of sufficient statistical power by Francis Collins, director of the National Institutes of Health, in an interview with CNN. Further, vaccine approval trials should include a demographically varied population, the lawmakers wrote.
To improve transparency, the lawmakers also asked Hahn to commit to including the FDA Vaccine and Related Biological Products Advisory Committee in reviewing any potential vaccine candidates and the National Vaccine Advisory Committee (an agency of the Health and Human Services department) as a resource to help advise on “difficult and sensitive questions of how to prioritize limited quantities of an approved vaccine—who is first in line.”