Seeking a fair shot
Will COVID-19 vaccine trials reflect America’s diversity?
WHEN U.S. scientists launch the first large-scale clinical trials for COVID-19 vaccines this summer, Antonio Cisneros wants to make sure people like him are included.
Cisneros, who is 34 and Hispanic, is part of the first wave of an expected 1.5 million volunteers willing togettheshotstohelpdetermine whether leading vaccine candidates can thwart the virus that sparked a deadly pandemic.
“If I am asked to participate, I will,” said Cisneros, a Los Angeles cinematographer who has signed up for two large vaccine trial registries. “It seems part of our duty.”
It will take more than duty, however,toensurethatclinicaltrialsto establish vaccine safety and effectiveness actually include representative numbers of African Americans, Latinos and other racial minorities, as well as older people and those with underlying medical conditions, such as kidney disease.
Black and Latino people have been three times as likely as white people to become infected with COVID-19 and twice as likely to die, according to federal data obtained viaalawsuitbythenewyorktimes. Asian Americans appear to account for fewer cases but have higher rates of death. Eight out of 10 COVID-19 deaths reported in the U.S. have been of people 65 and older. And the Centers for Disease Control and Prevention warns that chronic kidney disease is among the top risk factors for serious infection.
Historically, however, those groups have been less likely to be included in clinical trials for disease treatment, despite federal rules requiring minority and elder participation and the ongoing efforts of patient advocates to diversify these crucial medical studies.
Diversity matters
In a summer dominated by COVID-19 and protests against racial injustice, there are growing demands that drugmakers and investigators ensure that vaccine trials reflect the entire community.
“If Black people have been the ‘If
I am asked to participate, I will. It seems duty.’ part of our victims of COVID-19, we’re going to be the key to unlocking the mystery of COVID-19,” said the
Rev. Anthony Evans, president of the National Black Church Initiative, a coalition of 150,000 African American churches.
Evans and his team met in mid-july with officials from Moderna, the Massachusetts biotechfirmthatlaunchedthefirst COVID-19 vaccine trial in the U.S., to discuss a collaboration in which NBCI would supply African American participants. But that was less than two weeks before the start of a Phase Three trial expected to enroll 30,000 people, and Evans said the meeting was his idea.
“It’s not that the industry came to me,”hesaid.“iwenttotheindustry.”
Blacksmakeupabout13percent of the U.S. population but on average 5 percent of clinical trial participants, research shows. For Hispanics, trial participation is about 1percentonaverage,thoughthey account for about 18 percent of the population.
When it comes to trials for drug treatmentsandvaccines,diversity matters. For reasons not always fully understood, people of different races and ethnicities can respond differently to drugs or therapies, research shows. Immune response wanes with age, so there’s a highdose flu shot for people 65 and older.
Still, the pressure to produce an effective vaccine quickly during a pandemic could sideline efforts to ensure diversity, said Dr. Kathryn Stephenson, director of the clinical trials unit in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.
“One of the questions that has comeupis,‘whatdoyoudoifyou’re a site investigator and you have 250 people banging on your door — and they’re all white?’ ” she said.
Do you enroll those people, reasoningthatthefasterthetrial progresses, the faster a vaccine will be available for everyone? Or do you turn away people and slow down the study?
“You’re accelerating development of a vaccine, and if you hit a milestone, what is the meaning of that milestone if you don’t know if it’s very safe or effective in (a given) population? Is that really hitting the milestone for everyone?” she said.
Including people who are elderly or have underlying medical conditions is vital to the science of vaccines and other treatments, even if it’s more difficult to recruit patients otherwise healthy enough to participate, advocates said.
‘Business as usual’
New guidance from the federal Food and Drug Administration, which regulates vaccines, “strongly encourages” the inclusion of diverse populations in clinical vaccine development. That includes racial and ethnic minorities, elderly people and those with underlying medical problems, as well as pregnant women.
But the FDA does not require drugmakers and researchers to meet those goals and will not
refuse trial data that doesn’t comply. And while the federal government is rushing billions of dollars to fasttrack more than a half-dozen leading candidates for COVID-19 vaccines, the pharmaceutical firms producing them are not required to publicly disclose their demographic goals.
“This is business as usual,” said Marjorie Speers, executive director of Clinical Research Pathways, a nonprofit in Atlanta that works to increase diversity in research. “It’s very likely these (COVID-19) trials will not include minorities because there’s not a strong statement to do that.”
The vaccine trials are being coordinated through the COVID-19 Prevention Network, or COVPN, based at the Fred Hutchinson Cancer Research Center in Seattle. It draws on four long-standing federally funded clinical trial networks, including three that target HIV and AIDS.
Those trial networks were chosen in large part because they have rich relationships in Black, Latino and other minority communities, said Stephaun Wallace, director of external relations for COVPN. The hope is to leverage existing connections
based on trust and collaboration.
“Our clinical trial sites are prepped and ready to engage diverse people,” Wallace said.
Wallace acknowledged, however, that attracting a diverse population requires investigators to be flexible and innovative.
There can be practical problems. Clinic hours may be limited or transportation may be an issue. Older people may have problems with sight or hearing and require extra help to follow protocols. Distrust of the medical establishment also can be a barrier.
“Part of the consideration for many groups is not wanting to feel like a guinea pig or feel like they’re being experimented on,” Wallace said.