A hearing today entitled “Guidelines To Ensure a Safe and Effective COVID-19 Vaccine” brought five vaccine policy experts to the House Oversight and Reform Subcommittee on Economic and Consumer Policy. The political football issue was whether Operation Warp Speed, the administration’s vaccine development program, would properly balance speed with safety considerations. This was pumped by several Democrats. Nevertheless, a great deal of useful information was conveyed.
Chairman Rep. Raja Krishnamoorthi (D-IL) stressed the committee’s oversight of the FDA’s review and approval process. His letter of June 18 to FDA head, Dr. Stephen Hahn, called upon the FDA to have at least 30,000 participants in Phase 3 trials, and that the FDA not skip over consultations with the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Presently, such consultation is optional. Chairman Krishnamoorthi said, “We must expedite developing a vaccine, but we cannot cut corners in the process.” The ranking Republican on the subcommittee, Michael Cloud (TX), defended Operation Warp Speed, saying that it ”enables steps in the vaccine process to happen simultaneously. It doesn’t skip steps.”
