The color of COVID
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 to get the shots to help determine 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, to ensure that clinical trials to 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 by The New York Times. Asian Americans appear to but have higher rates of death. reported in the U.S. have been of people ages 65 and older. And the Centers for Disease Control and Prevention warns that 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 and participation and the ongoing efforts of patient advocates to diversify these crucial medical studies.
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 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 biotech firm that launched the 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 3 trial expected to enroll 30,000 people, and Evans said the meeting was his idea.
“It’s not that the industry came to me,” he said. “I went to the industry.”
Blacks make up about 13% of the U.S. population but on average 5% of clinical trial participants, . For Hispanics, trial participation is about 1% on average, though they account for about 18% of the population.
When it comes to trials for drug treatments and vaccines, diversity matters. For reasons not always fully understood, people of different races and ethnicities can to drugs or therapies, research shows. Immune response wanes with age, so there’s a 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 come up is, What do you do if you’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, reasoning that the faster the trial 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.
“We have to admit that older adults are the ones who are likely to develop side effects” to treatments and vaccines, said Dr. Sharon Inouye, director of the Aging Brain Center and a professor of medicine at Harvard Medical School. “On the other hand, that is the population that will be using it.”
People with kidney disease, which affects 1 in 7 U.S. adults, have been left out of clinical research for decades, said Richard Knight, a transplant recipient and president of the American Association of Kidney Patients. Nearly 70% of more than 400 kidney disease patients the organization surveyed in July said they’d never been asked to join a clinical trial.
Excluding from the vaccine trial such a large population vulnerable to COVID doesn’t make sense, Knight contended. “If you’re trying to manage this from a public health standpoint, you want to make sure you’re inoculating your highest-risk populations,” he said.
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 fast-track for COVID 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 group in Atlanta that works to increase diversity in research. “It’s very likely these [COVID] trials will not include minorities because there’s not a strong statement to do that.”
The vaccine trials are being coordinated through the , or CoVPN, based at the Fred Hutchinson Cancer Research Center in Seattle.