Drugmaker Moderna is being hailed for its efforts to include participants who are most at risk for COVID-19 — namely, people of color, older people and those with preexisting conditions — in its vaccine trials, which show a 94.5 percent efficacy rate against the virus. But some experts say there’s more work to be done once the vaccine becomes available.
In a call with reporters on Monday, Dr. Barry Bloom, a Harvard University immunologist and infectious disease expert, called it “striking” that Moderna’s phase III clinical trials included large numbers of participants who have been affected the most by the coronavirus pandemic.
“One of the striking things about both of these [Moderna] trials, but in the most recent trial ... is they have included groups of people over the age of 55,” Bloom stated. “They have quite a large number of those — 7,000. They’ve included people known to have comorbidities [such as] heart disease, presumably diabetes, and they have included a significant number of African Americans and Latinx recipients, trying to collect data on the broadest groups that are at high risk. And I give them credit for having stretched from the original designs and phase II to be able to get some data in these phase III studies on exactly the groups that would be most vulnerable.”
According to Moderna, the demographics for its U.S. COVID-19 vaccine trials were 63 percent white, 20 percent Hispanic/Latinx, 10 percent Black, 4 percent Asian and 3 percent other ethnicities. In addition, nearly 40 percent of participants were ages 45 to 64, and 25 percent were 65 and older.
Moderna, which did not respond to Yahoo Lifestyle’s request for comment, states on its website that its goal is to have participants in its trials who are “representative of the communities at highest risk for COVID-19 and of our diverse society.”
Pfizer and BioNTech SE’s COVID-19 vaccine trial demographics in the U.S. also included diverse candidates, but a smaller number of some, with 13 percent Hispanic/Latinx, 10 percent Black, 5.5 percent Asian, and 1 percent Native American. In addition, more than 45 percent of study participants were ages 56 to 85. Pfizer, whose phase III clinical trials showed a 90 percent effectiveness rate against COVID-19, also noted on its website that it purposely chose investigative sites in “diverse communities” that have been “disproportionately affected by COVID-19, to help ensure that individuals in communities that have been most impacted have the opportunity to participate.”
In September, during the last month of Moderna’s vaccine trial, the drugmaker made a “dramatic change,” according to Business Insider, by slowing down volunteer enrollment in an effort to recruit more people of color. Investigators reportedly worked with organizations in Black and other minority communities to “enroll a diverse pool of participants,” according to the National Institutes of Health.
Dr. Philip Grant, an infectious disease physician and assistant professor of medicine at the Stanford University Medical Center, tells Yahoo Life that part of the challenge with the vaccine trials was “the tension between enrolling participants quickly and spending time to do the education and outreach” needed to recruit more diverse participants. But, he says, “unless you actually do the work, you may get a homogeneous population.”
Dr. Uché Blackstock, founder and chief executive officer of Advancing Health Equity and Yahoo News medical contributor, acknowledges the “time pressure” that the vaccine trials are facing in light of the global pandemic. But, she tells Yahoo Life, that it’s “almost irrelevant — if you don’t have all the data you need on a vaccine and if the participant pool is not adequately diverse enough, it doesn’t really matter.”
So focusing on the most vulnerable in the vaccine trials was a “prudent decision” by Moderna, according to Dr. Leon McDougle, chief diversity officer at the Ohio State University Wexner Medical Center and associate dean for diversity and inclusion at the Ohio State University College of Medicine. “Greater participation in clinical trials by communities most impacted by COVID-19 will provide stronger evidence concerning the vaccines’ effectiveness,” he tells Yahoo Life.
McDougle adds: “People of color and older adults suffer disproportionately from infection by COVID-19. We need to know that the vaccine is both safe and effective in these populations. This will allow health care professionals and the community to have greater confidence in this much-needed preventive measure.”
Grant agrees, saying that it will help “when rolling out the vaccine that the vaccine trials are representative.”
Having diverse participants in the vaccine trials is important “not just because you want to see how the vaccine works in the communities that have been impacted the most,” says Blackstock, “but also because there are high rates of vaccine hesitancy in Black communities and other communities of color” stemming from a mistrust of the health care system and the medical racism many have faced.
Blackstock explains that having more diverse clinical trial participants can be “reassuring symbolically to people, especially in the community where people have been hardest hit.”
Once the vaccine is available, Blackstock says, vaccine manufacturers and state departments of public health, as well as schools, churches and community outreach organizations, “need to think of what kind of messages are we going to do in terms of educating people and reassuring people that [the vaccines are] both safe and effective.”
As Blackstock puts it: “Having diverse participants in the trials is one critical point to address. Another even more critical point is that people feel comfortable taking the vaccine.”
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