Coronavirus Vaccine Trial Results May Be Delayed Because It Has Failed to Recruit Enough Black, Hispanic and Native American Volunteers
Mary Kekatos, Daily Mail, October 6, 2020
Private contractors hired by Moderna Inc for its coronavirus vaccine trial failed to enroll enough minorities, causing a slowdown.
The contractors were unable to recruit enough black, Latino and Native American participants to determine how well a jab works in these populations, company executives and 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 communities of color.
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 black Americans 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.
What’s more, 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.
Black Americans made up only about seven percent of the trial as of September 17, but that figure should be closer to 13 percent to reflect the actual US population.
Moderna is one of the furthest along in the US race for a vaccine seen as essential to ending a pandemic that has claimed more 210,00 American lives.
It received more than $1 billion in government funding to develop and produce its candidate, and another $1.5 billion to supply it to the general public.
On Moderna’s website, as many as 17 of the 100 participating trial sites are listed as active but not recruiting, without listing a reason.
Bancel said the enrollment slowdown, announced in early September, will not keep the company from seeking emergency use authorization (EUA) for its vaccine in the United States, provided initial results show it to be safe and effective.
Even with that approval, there are likely to be hurdles to convincing black Americans to take the vaccine.
According to a Pew Research Center survey released in September, only 32 percent of black adults said they would definitely or probably get a COVID-19 vaccine, compared with 52 percent of white adults, 56 percent of Hispanics and 72 percent of Asian Americans.
Some trial investigators attributed the minority recruitment shortfall in part to the demands of testing a coronavirus vaccine at unprecedented speed.