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Exclusive: Moderna Vaccine Trial Contractors Fail to Enroll Enough Minorities, Prompting Slowdown | Top News

CHICAGO (Reuters) – Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest along in the U.S. race for a vaccine seen as essential to ending a pandemic that has claimed over a million lives worldwide. It received more than $1 billion in government funding to develop and produce its candidate, and another $1.5

Moderna vaccine trial contractors fail to enroll enough minorities: sources

Tony Potts, a 69-year-old retiree living in Ormond Beach, receives his first injection as a participant in a Phase 3 COVID-19 vaccine clinical trial sponsored by Moderna at Accel Research Sites on August 4, 2020 in DeLand, Florida.

Paul Hennessy | NurPhoto | Getty Images

Private contractors hired by Moderna to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But Covid-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of Covid-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) Covid-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest

Exclusive: Moderna vaccine trial contractors fail to enroll enough minorities, prompting slowdown

CHICAGO (Reuters) – Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyder/File Photo

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest along in the U.S. race for a vaccine seen as essential

Ethnic Minorities Affected Most in Rise of Early Onset T2 Diabetes

Adult early onset type 2 diabetes disproportionately affects South Asian and African-Caribbean individuals, who have an earlier age of onset and, in the case of South Asian people, an accelerated development of the disease compared with White people, indicates a UK primary care data analysis.

The research was presented at the European Association for the Study of Diabetes (EASD) Virtual Meeting 2020 on September 24, which was held online due to the COVID-19 pandemic.

BMI ‘Dose Effect’

A team from Imperial College London examined data on more than 1.4 million primary care patients, finding that, compared with White people, the prevalence of early onset type 2 diabetes (defined as at age 18-44) was more than twice as high in African-Caribbean individuals, and over three times higher in South Asian people.

The results also showed that there was a “dose effect” of body mass index (BMI), with younger onset associated with an increased rate of overweight and obesity, and that the incidence of early onset type 2 diabetes rose much faster in South Asian individuals than their White counterparts.



Janthula Ranchagoda

Study author Janthula Ranchagoda, a fifth year medical student in the Department of Medicine, Imperial College London, said that, with the increasing incidence of early onset type 2 diabetes: “The burden this group is going to pose in the coming years is only going to rise.

“The other key point is that data from cardiovascular outcome trials in this group is severely lacking, because people with type 2 diabetes under the age of 40 are severely underrepresented in large clinical outcomes studies.”

Mr Ranchagoda added that, consequently, “our knowledge base to provide targeted treatments to this group is inhibited”.

The results also have “relevance to the current pandemic”, he said. “We know from studies that people with obesity and those from ethnic minority groups are particularly at risk from COVID-19 and there is some reflection to be had whether or not this early onset type 2 diabetes group in adults has an additional risk from the SARS-CoV-2 pandemic.”

‘Rising Problem’

Dr Shivani Misra, Department of Medicine, Imperial College London, who led the study, said that the “elephant in the room for any researcher working on early onset type 2 diabetes” is how to tackle the increasing incidence.

She told Medscape Medical News: “I think no single approach is going to be sufficient to deal with this huge, rising problem.

“Obviously there are some great public heath initiatives coming out of NHS England at the moment, both the diabetes prevention programme and also the type 2 diabetes remission programme.”

However, Dr Misra said that the “evidence base that those programmes work in people with early onset type 2 diabetes is lacking, and there’s some emerging evidence that those programmes will need to be tweaked for specific ethnic minority groups”.

Another issue is that many of the individuals with early onset type 2 diabetes have been hard to reach in terms of prevention and management campaigns.

“There’s often very strong family