Moderna, the first company to launch large-scale clinical trials for a coronavirus vaccine, has enrolled minorities at levels more than three times lower than those requested by Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.
The trials could be delayed if Moderna doesn’t recruit sufficient numbers of minorities to join them.
Moderna is aiming to recruit 30,000 volunteers into its Phase 3 trial, and in a tweet Friday evening revealed that 18% of the 13,194 volunteers enlisted so far have been minorities, which the company said included “Black or African American, Latinx, American Indian and Alaskan Native.”
Fauci told CNN earlier this week that he wanted to see minorities enrolled in coronavirus vaccine trials at levels that are at least double their percentages in the population. That means at least 66.4% of the volunteers would come from those four groups.
According to census data, 18.5% of the US population is Latino, 13.4% is Black, and 1.3% is American Indian and Alaskan Native.
Fauci said he wants minorities to be enrolled at more than double their percentages in the population because minorities have been disproportionately hit by the pandemic. He made clear that this number was a goal, and not a requirement.
He said participation of minorities in the trials should “aim to match the burden of disease. We’d like to do that – whether or not we get there I don’t know.”
Minority representation is also important because safety and efficacy of the vaccine might be different for minority groups than for White people, and so a substantial percentage of the participants need to come from those groups.
The company said it was trying.
“Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study,” the company said in a statement released Friday.
“The clinical research sites, with the support of the company, are working within their local communities to reach a diverse population. Working together with collaborators, the company hopes to achieve a shared coal that the participants in the [vaccine trial] are representative of the communities at highest risk for COVID-19 and of our diverse society.”
In its Friday night tweet, Moderna also announced that the company had so far recruited 13,194 participants. At that pace, the company will easily enroll 30,000 participants in early to mid-September.
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However, Fauci has said that if the right percentages of minorities are not met by the time Moderna reaches 30,000 study subjects, the trials should keep recruiting.
“We’re going to keep going until we get there. We may just need to accrue more volunteers than [30,000],” he said.