While Black people and Latinos account for more than 50% of Covid-19 cases nationwide, so far they make up at least 15% of participants in the nation’s first large-scale clinical trial of a coronavirus vaccine tests, according to data obtained by CNN from a government official.
That could potentially delay a vaccine from arriving on the market.
Moderna, the first company in the US to conduct a Phase 3 clinical trial, aims to enroll 30,000 volunteers. In the first three weeks, it already has 8,374 yards, according to an email received by CNN from the company to its researchers.
Choppy Waters
Michael reviewed Moderna’s enrollment data and shared the percentages for minorities with CNN.
“There is now a lot of discussion about how Moderna can change the direction of her ship so that she can optimize the enrollment of key populations,” Michael said.
Moderna is on track to register its 30,000 participants by mid-September. But if they are unable to increase the number of minorities, the panel of experts overseeing the trial could tell Moderna that they should take the time to recruit more participants from minority groups.
“The Data Security Board could delay the trial,” Michael said.
Spokesmen for Moderna did not respond to CNN’s request for comment on this story.
Moderna has contracts with 89 sites in the US to conduct its Phase 3 clinical trial. Researchers at two of those sites tell CNN that the company has asked them to limit the number of participants they enroll to to no more than 20 per day.
Part of the reason is that care can be taken to recruit more minorities, they said.
“We need to take the time to evaluate the people who want to study to make sure they meet inclusion criteria,” said Dr. Richard Novak, who runs the site at the University of Illinois at Chicago.
Dr. Carl Fichtenbaum, the lead researcher at the University of Cincinnati, echoed the sentiment. “We want to have the right people in this trial, and that can take time,” he said.
Recruit the right people
There are two main reasons why vaccine studies should involve more minorities.
Black people account for 22% of coronavirus cases, but only 4.5% of Moderna’s participants. Latinos represent 33% of the cases, but only 10% of Moderna’s participants.
The other reason why it is important to include substantial numbers of minorities is that in order to succeed in the research, a significant number of volunteers have to be at high risk of first becoming infected and becoming ill with Covid-19.
If those who volunteer for a trial with a coronavirus vaccine get their shots and then stay home, then at the end of the study they may test very negatively for the virus, not necessarily because the vaccine worked, but because they never encountered the virus in the first place.
So in every vaccine study, including this one, researchers are looking for research studies that are most likely to come in contact with the virus in their daily lives.
This includes, for example, health care workers, as well as minorities, who are more likely to have essential jobs that require personal work, and are more likely to live in multigenational, multifamily households, among other factors.
Easier said than done
This has led government agencies to reach out to underage groups to encourage participation in these and other coronavirus tears.
“There’s a tremendous amount of pressure right now. I’ve never seen community control get this level of play. Not even close. Never,” Michael said.
In an earlier statement for an earlier story, a Moderna spokesman said the company’s 89 test sites “actively collaborate with its local communities to reach a diverse population of volunteers.”
The spokesman, Ray Jordan, added that “we hope to achieve a shared goal that the participants in the [Covid-19 vaccine] study are representatives of the communities with the highest risk for COVID-19 and of our diverse society. “
He said Moderna had recently taken “important action” to recruit minorities after her studies.
“They are very actively looking for solutions so that they do not end up with a cohort that is too young, too low risk, and honestly too white,” Michael said. “I think this issue is getting the attention it needs and has gotten it very quickly,” Michael said.
But so far the attempt has not been very successful.
“When we ‘black people hear’ clinical threads, ‘we think’ we will not be investigated ‘- and that’s about economic status and educational status, not one sector,” Harris said.
Dana Vigue contributed to this story.
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