Do the COVID-19 Vaccine Trials Reflect US Diversity?

When US scientists start their first large-scale clinical trials COVID-19 vaccine This summer, Antonio Cisneros wants to make sure people like him are included.

Latin Cisneros is part of the first wave of volunteers taking shots to see if they can stop the virus that caused the deadly pandemic.

“If I’m asked to join, I’ll be there,” said Cisneros, 34-year-old cinematographer in Los Angeles, who enrolled in two large vaccine trials enrollments. “It seems to be part of our duty.”

It will take longer to ensure that the trial actually includes a representative number of Latin Americans, Black Americans and other racial minorities, as well as the elderly and those with underlying illnesses.

In the United States, blacks and Latins Three times as likely Federal data show that whites are twice as likely to die from COVID-19 infections. Asian Americans Occupy a small number of cases High mortality rate. 8 out of 10 deaths from COVID-19 Reported in the United States are people over the age of 65.

However, historically, these groups were unlikely to be included in clinical trials, albeit as required by federal regulations. a few And Elder Patient advocacy participation and ongoing efforts to diversify these important medical studies.

In the summer when protests against COVID-19 and racial fraud prevail, there is an increasing demand for vaccine trial participants to reflect across the country.

“If a black person was the victim of COVID-19, we are the key to unlocking the mystery of COVID-19,” he said. Rev. Anthony Evans, National Black Church Initiative, President of the Union of 150,000 African American Churches.

In mid-July, Evans and his team joined the biotechnology company Moderna Inc. First COVID-19 vaccine trial In the United States, we will discuss the collaboration NBCI offers to African American participants. But within two weeks of the Phase 3 trial, 30,000 will be enrolled, and Evans said the meeting was his idea.

“The industry hasn’t come to me,” he said. “I went to the industry.”

Study show Blacks make up about 13% of the US population, but the average number of participants in clinical trials is only 5%. Latin Americans make up about 18% of the population, but on average only 1% of study participants.

Diversity is important in vaccine and drug trials. People of different races and ethnicities are Different reaction For drugs and treatment. Because the immune response decreases with age, High dose influenza vaccination For ages 65 and up.

Still, the pressure to rapidly produce effective vaccines during a pandemic could evade efforts to ensure diversity. Dr. Kathryn Stevenson, Director of Clinical Trials Unit Virology and Vaccine Research Center At Beth Israel Deaconess Medical Center in Boston

“If you’re accelerating the development of a vaccine and don’t know if it’s very safe or effective when you reach a milestone, what is the meaning of that milestone? [a given] population? Is it really a breakthrough for everyone? She said.

Inclusion of the elderly is essential to the science of vaccines, even if it is more difficult to recruit those patients and are more likely to develop side effects. Dr. Sharon Inouye, Director of Aging Brain Center and Professor of Medicine at Harvard Medical School.

After all, she said, “it’s the population that will use it.”

New guidance A diverse population from the US Food and Drug Administration that regulates vaccines Clinical vaccine development.. This includes racial and ethnic minorities, the elderly, those with underlying illnesses, and pregnant women.

However, the FDA does not require pharmaceutical companies or researchers to achieve these goals, and it does not reject noncompliant test data. The federal government spends billions of dollars Over half a dozen major COVID-19 vaccine candidates, The pharmaceutical companies that manufacture them do not have to publicly disclose their demographic goals.

“This is always the case,” Marjorie Spears, Executive Director Clinical research pathway, A nonprofit organization in Atlanta working to increase research diversity. “These are very likely [COVID-19] The trial does not include the minority, as there is no strong statement to do so. “

The trial COVID-19 Prevention NetworkIt utilizes four federally funded long-term clinical trial networks, including three targeting HIV and AIDS. They were chosen primarily because of their rich relationships with blacks, Latinos and other diverse communities, he said. Stephen Wallace, Director of External Relations of the organization.

“Our clinical trial site is ready and ready to engage with a diverse group of people,” he said.

Wallace admitted that researchers need to be flexible and innovative to attract a diverse population. Clinic hours may be limited or transportation may be a problem. Older people may have visual or hearing problems and may need additional help to follow the protocol.

Distrust of medical institutions can also be a barrier. Black Americans, for example, have a wary grounded in notorious post-medical experiments Tuskegee study And the exploitation of Henrietta is missing.

“Part of the consideration for many groups is that they don’t want to feel like guinea pigs or feel like they’re being experimented with,” Wallace said.

Moderna is a company whose participants are Phase 3 trial “COVID-19 represents the most risky communities and our diverse societies.”

However, Results of the company’s Phase 1 trial Of the 45 people included in the safety test, six were Latino, two were black, one was Asian, and one was Native American.

Phase 1 and Phase 2 clinical trials Evaluate vaccine safety and optimal doses in a small group. Phase 3 trials test the efficacy of drugs in tens of thousands of people.

Investigators at nearly 90 sites across the United States are preparing to recruit participants for Phasena’s Phase 3 trial. Dr. Carlos Del Rio, Associate Dean, Emory University School of Medicine, is recruiting 750 volunteers at three Atlanta regional sites. Half receive the vaccine. Half are placebo injections.

Del Rio had Marked success We have recruited a minority into the HIV trial and expect similar results to the COVID-19 vaccine trial. “We are doing our best to escape to the most endangered community,” he said.

Vaccine volunteers like Cisneros, meanwhile, want to start a Phase 3 trial. He said it was a way for the US government to take action when it fails to protect ethnic minorities, the elderly and other vulnerable people.

“The government is supposed to help people who can’t protect themselves,” he said. “It seems that the only thing they want to protect is not the one who has the money, the one who has the gun, and the brown guy like me.”

JoNel Aleccia Kaiser Health NewsKaiser Health NewsEditorial independent program of Henry J. Kaiser Family FoundationHenry J. Kaiser Family Foundation.. We are not affiliated with Kaiser Permanente.