It was Ashton Kutcher’s idea, originally. The tech company actor and investor recently spoke with David Agus, MD, CEO of the Lawrence J. Ellison Institute for Transformative Medicine at USC, about a formidable challenge in the battle against COVID-19: recruiting enough volunteers for the many studies. . . . . necessary to test vaccines and experimental therapies. Kutcher suggested an awareness campaign in which Americans who had already volunteered for a study record a video explaining why they had done so. “Their unfiltered voices will offer a powerful testimony,” Agus recalls Kutcher saying, and that’s what we need to get the message across.
This simple notion has now morphed into a surprising public service announcement that is spreading across the country. The 90-second public service announcement, narrated by Harrison Ford and produced by David Ellison’s Skydance Media in association with the National Institutes of Health’s COVID-19 Prevention Network, launched Friday on CBS and is scheduled to air. There are also shareable versions of the ad, which features a series of personal statements from clinical trial volunteers, designed for Facebook, YouTube, and Instagram.
Hearing President John F. Kennedy’s poignant call to action: “Don’t ask what your country can do for you, ask what you can do for your country,” the new campaign urges Americans to volunteer in a trial. . . . . through the prevention of COVID-19.
About 500,000 Americans have already signed up to potentially be included in COVID clinical trials to date, but we will likely need a million more to sign up, says Agus, For context, ongoing phase 3 trials for only the top five candidate vaccines – those being developed by Pfizer (with German company BioNTech), AstraZeneca (with Oxford University), Moderna, Johnson & Johnson. according to their protocols. But in reality, they require many more volunteers than that simply to get the necessary compositions of race, age, health, and location – distributions that are necessary to ensure that the test populations fairly represent the composition of the wider society.
Bio.org, a trade group for the biopharmaceutical industry, is currently tracking 188 vaccine candidates, 198 antiviral therapies, and 351 potential treatments in various stages of development. Before any of them can be shown to be safe and effective, and, in the United States at least, the FDA approves their use, they would generally have to be tested in human volunteers in two well-controlled studies. To defeat COVID, we will probably need several viable vaccines and therapies: first, to prevent the SARS-CoV-2 virus from causing the disease; the second, to treat the most serious infections that arise. And that means we will need a lot of volunteers to test them.
Why so many? For one reason, COVID vaccines will eventually be administered not just to a limited group of seriously ill patients, but to billions of people around the world. In the US, most of the country’s 330 million people will need to be vaccinated to reduce the spread. That sets the bar for safety and efficacy incredibly high, says Agus.
While extremely safe in general, vaccines, like any medicine, can affect different people in different ways. For any potential COVID vaccine or therapy to truly demonstrate that it is appropriate for global use, it will have to be tested in very young and very old people, as well as people with any number of pre-existing medical conditions. That’s not a small number: According to the Centers for Medicare & Medicaid Services (CMS), between 50 million and 129 million non-elderly Americans have a pre-existing health condition in some form.
It is equally important that vaccines and other medications are tested in people of different races and nationalities. A study that examined 167 new FDA-approved drugs between 2008 and 2013 found that about one in five acted differently in some racial or ethnic groups compared to others. In some cases, the difference lies in the way the drug is absorbed, metabolized, or eliminated, ultimately leaving the drug more or less exposed in the body, depending on who is taking it; in others, it produced a different response; in others, it did both.
And in the case of COVID, such differences in drug or vaccine interactions could possibly have a much greater impact, given the huge disparity in disease outcomes seen so far. According to data released by the CDC in August, African Americans with COVID have a 4.7 times higher hospitalization rate than non-Hispanic whites and a 2.1 times higher death rate. Hispanic Americans and American Indians are also much more likely to become seriously ill from COVID, or die from it, than their white counterparts. Although much of this increased risk may be due to other underlying conditions more prevalent in these groups, other biological factors may still be at play. That is all the more reason to ensure that clinical trials include significant numbers of Black and Latino volunteers so that potential complications can be discovered before any vaccine or drug is administered to many millions of people.
In the case of “blind” vaccine trials, of course, participants will not know in advance whether they will receive the experimental vaccine or a placebo. However, what they will know is that they are helping to end this pandemic.
