Will 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 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 obtained via a lawsuit by The New York Times. 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 ages 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.
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 first COVID 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 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, research shows. 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 respond differently to drugs or therapies, research shows.