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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

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

Covid-19 Cases Jump in Canada, Prompting New Restrictions

OTTAWA—Canada is seeing a sharp rise in cases of Covid-19, alarming health officials and triggering a second round of lockdowns and strict distancing recommendations.

Average daily case counts have nearly reached the peak levels set in April, according to the country’s chief public-health officer. Confirmed cases for the past seven days—9,636 ended Sept. 28—rose 29% from the previous seven-day period, according to data from Johns Hopkins University, and are roughly triple the tally from the last seven days in August.

“This is worrisome,” Dr. Theresa Tam, Canada’s chief public-health officer, said Tuesday. “Things have escalated quickly and can escalate further.”

Nearly all of the growth in confirmed infections is in the two biggest provinces, Ontario and Quebec, which account for nearly two-thirds of the population but 80% of cases. Overall, though, Canada’s case count has been much lower than those of the U.S. and Europe.

The pickup can be partly attributed to transmission at private social gatherings, such as parties hosted by young adults, dinner parties and weddings, health officials say. Infectious-disease experts said other factors include children returning to school, workplaces reopening and cooler weather that is driving people indoors.

Some officials—including Prime Minister Justin Trudeau—warn a second wave of infections could produce more cases than witnessed in the spring.

Canada, with a population of 38 million, has recorded around 155,000 Covid-19 cases to date. So far, the country has avoided the wave in infections seen in the U.S. U.K., and Europe, and its health care system hasn’t been overburdened. Nearly all regions in Canada began lifting restrictions starting in May after some initial success containing the spread.

Canada is starting to see “exponential growth that is starting to mimic what we have seen in the U.K. and what was seen a month and a half earlier in France and Spain,” said Dr. Andrew Morris, a professor at the University of Toronto’s medicine department and an infectious-disease specialist.

Last week, the U.K. introduced fresh restrictions to quell its second wave, whereas France and Spain have adopted more targeted measures such as earlier closing times for restaurants and taverns, and limits on when residents can leave their neighborhoods.

Quebec moved on Monday to re-impose restrictions. It decided to ban bars and restaurants from offering outdoor and indoor service for a 28-day period in Montreal—Canada’s second-largest city—and the provincial capital, Quebec City, starting Oct. 1. It has also ordered libraries, museums and movie theaters to shut down for that period, and prohibited gatherings at homes with few exceptions.

Ontario, Canada’s most populous province, has resisted imposing widespread restrictions, instead relying on people’s voluntary cooperation with distancing and staying home when ill. Now, the City of Toronto is considering further reducing seating capacity in restaurants and other measures targeting social interaction.

“Our collective actions will decide whether we have a wave or a tsunami,” warned Ontario’s head of government, Doug Ford.

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