CDC Director Robert Redfield provided an important window into the design of the COVID-19 vaccine Phase 3 clinical trials in the U.S. On an interview Aug. 12 on Dr. John Whyte’s “Coronavirus in Context” video series, Redfield said that “clearly there’s a comprehensive trial right now that will accommodate the people that are either most at risk because of comorbidities and age or at risk because of their jobs.” He made the point that the Phase 3 trial design, unlike typical clinical trials, will deliberately include older patients, those with diabetes or heart disease, and those in the frontline jobs, medical workers. Such a new design begins to address the balancing of traditional efficacy issues of Phase 3 trials with the special circumstances of a pandemic. Of some note, the blindness towards just such a Phase 3 design element in Russia’s vaccine rollout — where they are featuring the inclusion of the frontline healthcare workers — has been the basis for a lot of hysterical attacks and cynicism this week against Russia.
Redfield’s “war-mobilization” no-nonsense approach in the interview was a notable and welcome element. He stressed the imminent danger of the pairing of the unresolved COVID situation with an forthcoming flu season, including the commingling and confusion of symptoms in the population and the greater strain upon medical facilities. The good news is that, according to a recent WHO update on influenza, the flu is at lower levels presently than anticipated. (It is thought that the increased hand hygiene and social distancing has helped here.) However, Redfield warned that only 47% of Americans made use of the flu vaccine last year and those levels have to be driven up massively, at least above 65%, to avert the population from being overwhelmed. He called for the flu vaccine to be added to the list with masks and social distancing. He appealed: “This is a year that I’m asking people to really think deep down about getting the flu vaccine.” His CDC has already purchased 20 times their normal amount of flu vaccine doses (10 million instead of the normal 500,000), for uninsured Americans.
