The first trial of the Covid-19 vaccine is progressing at a good pace, but officials remain “very concerned”

Rough waters

Michael looked at Moderna’s signup data and shared the minority percentages with CNN.

“There is a lot of talk now about how Moderna can change the direction of their ship to optimize the enrollment of key populations,” said Michael.

Moderna is on track to complete the registration of its 30,000 participants by mid to late September. But if they can’t increase the number of minorities, the panel of experts overseeing the trial could tell Moderna they need to take the time to recruit more participants from minority groups.

“The data security oversight committee could slow down the trial,” Michael said.

Moderna spokespersons did not respond to CNN’s request for comment for this story.

Moderna has contracted with 89 sites in the United States to conduct its Phase 3 clinical trial. Researchers at two of those sites tell CNN the company has asked them to limit the number of participants they enroll to no more. from 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 assess people who want to participate in the study to make sure they meet the inclusion criteria,” said Dr Richard Novak, who heads the site at the University of the Illinois to Chicago.

Dr Carl Fichtenbaum, the senior researcher at the University of Cincinnati, echoed this sentiment. “We want the right people in this trial, and it can take time,” he said.

Recruit the right people

There are two main reasons why vaccine trials need to include more minorities.

Blacks make up 22% of coronavirus cases, but only 4.5% of Moderna study participants. Latinos make up 33% of cases, but only 10% of Moderna participants.

The other reason why it is important to include a substantial number of minorities is that for the study to be successful, a significant number of volunteers must be at high risk of becoming infected and sick with Covid-19 in the first place.

If those who volunteer for a coronavirus vaccine trial get vaccinated and then stay home, at the end of the study they may very well be tested negative for the virus, not necessarily because the vaccine worked. , but because they have never encountered the virus in the first place.

So, in any vaccine study, including this one, researchers look for study subjects most likely to come into contact with the virus in their daily lives.

This includes healthcare workers, for example, as well as minorities, who are more likely to hold essential jobs requiring in-person work and more likely to live in multigenerational and multi-family households, among other factors.

Easier said than done

This has led government agencies to reach out to minority groups to encourage participation in this and other coronavirus trials.

“There’s a huge pressure on this now. I’ve never seen the community engagement reach this level of play. Not even close. Never,” said Michael.

In an earlier statement for a previous article, a spokesperson for Moderna said the company’s 89 trial sites “are actively working with their local communities to reach a diverse population of volunteers.”

Spokesman Ray Jordan added that “we hope to achieve a common goal that participants in the [Covid-19 vaccine] are representative of the communities most exposed to COVID-19 and of our diverse society. “

He said recently that Moderna had recently taken “significant steps” to recruit minorities into their study.

“They are very actively looking for solutions so that they don’t end up with a cohort that is too young, too low risk and frankly too white,” said Michael. “I think this problem is getting the attention it needs and got it really quickly,” Michael said.

But so far the effort has not been very successful.

“When we black people hear ‘clinical trials’ we think ‘we’re not going to be researched’ – and that depends on economic circumstances and level of education, not just one. sector, ”Harris said.