It was Ashton Kutcher’s idea, originally. The actor and technology company investor was talking recently with David Agus, M.D., 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 clinical studies needed to test experimental vaccines and therapies. Kutcher suggested an awareness campaign in which Americans who had already volunteered for a study record a video explaining why they’d done it. “Their unfiltered voices will offer a powerful testimony,” Agus recalls Kutcher saying, and that’s what we need to get the message out. “The vaccine effort isn’t about politics,” says Agus. “It’s simply about good science and civic duty and saving the lives of your loved ones and neighbors. Those who have volunteered for trials understand that—and can communicate that better than anyone.”
This straightforward notion has now been transformed into a striking public service announcement that’s being rolled out nationally. The 90-second PSA, narrated by Harrison Ford and produced by David Ellison’s Skydance Media in partnership with the National Institutes of Health’s COVID-19 Prevention Network, launched Friday on CBS, and is slated to air on other major television and cable networks as well. There are also shareable versions of the ad—which features a number of personal statements from clinical trials volunteers, designed for Facebook, YouTube, and Instagram.
Hearkening back to President John F. Kennedy’s stirring call to action—“Ask not what your country can do for you, ask what you can do for your country”—the new campaign urges Americans to volunteer for a clinical trial through COVID-19 Prevention Network’s registration platform, which is helping to find participants for all the major ongoing studies.
About 500,000 Americans have already registered to be potentially included in COVID clinical trials to date, but we’ll likely need a million more to sign up, says Agus, who is working closely with many of the international vaccine efforts. For context, the ongoing Phase 3 trials for just the five leading vaccine candidates—those being developed by Pfizer (with the German firm BioNTech), AstraZeneca (with Oxford University), Moderna, Johnson & Johnson, and Novavax—require 174,000 study participants, according to their protocols. But in truth, they require many more volunteers than that merely to get the needed compositions of race, age, health status, and location—distributions that are necessary to ensure that the trial populations fairly represent the makeup of society at large.
Bio.org, a trade group for the biopharma industry, is currently tracking 188 vaccine candidates, 198 antiviral therapies, and 351 would-be treatments in various stages of development. Before any one of them can be proven safe and effective—and, in the United States at least, approved for use by the FDA—they would generally need to be vetted in human volunteers in two well-controlled studies. To defeat COVID, it’s likely that we’ll need several viable vaccines and therapies—the first, to prevent the SARS-CoV-2 virus from causing illness; the second, to treat the more serious infections that do occur. And that means we’ll need lots of volunteers to test them.
Why so many? For one reason, COVID vaccines will eventually be given not just to a confined group of patients with serious disease, but rather to billions of people around the world. In the U.S., most of the country’s 330 million people will need to be vaccinated in order to curtail the spread. That puts the bar for both safety and effectiveness incredibly high, says Agus.
While extremely safe overall, vaccines—as with any medicine—can affect different people in different ways. For any candidate COVID vaccine or therapy to truly demonstrate that it’s appropriate for global use, it will have to be tested in the very young and the very old, as well as in people with any number of pre-existing medical conditions. That’s no 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 of some form.
It’s equally important that vaccines and other drugs be tested on people of different races and national origin. One study that examined 167 new drugs approved by the FDA between 2008 and 2013 found that roughly one in five acted differently in some racial or ethnic groups versus others. In some of the cases, the difference lay in the way the drug was absorbed, metabolized, or eliminated, which ultimately left more or less drug exposed in the body, depending on who took it; in others, it produced a different response; in still others, it did both.
And in the case of COVID, such differences in vaccine or drug interactions could conceivably have far more impact, given the huge disparity in disease outcomes witnessed so far. According to data posted by the CDC in August, Black Americans with COVID have a rate of hospitalization that’s 4.7 times higher than that for non-Hispanic whites, and a rate of death 2.1 times higher. Hispanic Americans and American Indians are also far more likely to get extremely ill from COVID, or die from it, than their white counterparts. Though much of this increased risk may be due to other underlying conditions more prevalent in those groups, there may as yet be other biological factors at work. That is all the more reason to make sure clinical trials include substantial numbers of Black and Latino volunteers—so that potential complications can be unearthed before any vaccine or drug is given to many millions of people.
But reports suggest that the opposite is happening in the COVID-related clinical trials already underway. As of late August, just one-fifth of those enrolled in the Pfizer and Moderna vaccine studies, for instance, were Black or Hispanic, according to reporting by the Washington Post. And among those signing up for the COVID-19 Prevention Network’s Volunteer Screening Registry, the share of both groups combined was closer to 10%. (In the U.S. as a whole, for comparison, Blacks make up 13.4% of the population; Latinos, 18.%.) While the under-representation of minority groups in clinical trials is a longstanding problem, the scale of the challenge in the COVID era is at a whole new level.
Which is why the creators of the new PSA hope to bring their message to television networks with large numbers of Black viewers (including BET and the Oprah Winfrey Network) and to Spanish-speaking audiences (Telemundo, and Univision).
In addition to racial and ethnic diversity, says Agus, it’s important that the volunteer registry have people from all over the country (particularly in areas where the disease is spreading) and include those with a wide range of health conditions. Clinical trials are currently in progress at some 100 medical centers around the U.S., with studies typically asking volunteers to visit the research site 10 or times over one to two years. (The COVID-19 Prevention Network has a comprehensive and transparent FAQ here.)
In the case of the “blinded” vaccine trials, of course, participants will not know ahead of time whether they’ll get the experimental vaccine or a placebo. What they will know, however, is that they’re helping to bring this pandemic to an end.