By Jared S. Hopkins
Researchers and companies developing Covid-19 vaccines are
taking new steps to tackle a longtime challenge: People who need
the vaccines most urgently, including Blacks and Latinos, are least
likely to participate in clinical trials to determine whether they
work safely.
Racial and ethnic minority groups are more likely to be
hospitalized and die from the new coronavirus, partly due to
socioeconomic factors and underlying health conditions, data show.
But clinical trials to evaluate drugs and vaccines historically
underrepresent minorities, and researchers are concerned enrollment
now under way to test Covid-19 vaccines will be no different.
While thousands of Americans have shown interest in testing
vaccines, they are mostly young, white and healthy, according to
researchers. Public-health officials say vaccines, to be effective,
have to be proved to work safely across all age groups, races and
ethnicities--and especially among those at high risk of contracting
the virus.
Recruiters have to overcome several hurdles in high-risk
populations: misinformation, decades of mistrust of health-care and
government institutions, and fresh tensions around discrimination
in the U.S.
To do so, researchers are joining with community leaders,
churches and advocacy organizations to educate about the benefits
of vaccination. They are trying to reach potential subjects through
social media and minority physicians. And they are hoping that
simply testing the vaccines in locations with high proportions of
minority populations will draw interest.
"You have to be able to get into some of these communities where
there may not be as much experience or trust for science, and just
be very convincing in helping people understand why this is
important for their health," said Dr. Angela Branche of the
University of Rochester Medical Center, in New York, which began
testing a Covid-19 vaccine from Pfizer Inc. and BioNTech SE last
week.
With Covid-19 vaccine testing moving quickly, some scientists
are skeptical that drugmakers will sign off on wide-ranging
recruitment strategies. "Everybody's against the gun in terms of
enrolling as quickly as possible," 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.
"Nobody's really going to want to wait around for those efforts to
mature."
Vaccines are considered crucial to stopping the spread of the
coronavirus, and pivotal studies seeking 30,000 participants,
including one led by Pfizer, are under way. Food and Drug
Administration guidelines for Covid-19 vaccines say the agency
"encourages" enrollment of racial and ethnic minorities, but
doesn't require it for approval.
Francis Collins, director of the National Institutes of Health,
said recent social upheaval sparked by the death of George Floyd
has likely added to feelings of mistrust between minority groups
and government or pharmaceutical companies. "Yet we need their
participation if this is going to have a meaningful outcome," he
said. "We've got work to do."
Covid-19 hospitalization rates for Blacks and Latinos are nearly
five times that of whites, according to the Centers for Disease
Control and Prevention. Blacks suffer almost one-quarter of
Covid-19-related deaths in the U.S., though they make up only about
13% of the population.
The drug industry has a poor record of minority participation in
clinical trials, according to research and industry officials. Last
year, Blacks made up about 9% of participants in trials for novel
drugs while nearly three out of every four subjects were white,
according to the FDA.
Some experts say efforts to diversify enrollment add to the cost
of running a trial, and challenges including lack of access to
basic health care and transportation in some communities make
recruitment difficult. But the bigger problem, they say, is
deep-rooted mistrust of health-care authorities after a tainted
history of unethical medical experimentation on Blacks and other
minorities.
A well-known example is the Tuskegee syphilis study, which began
in the 1930s and went on for 40 years. Black men who participated
weren't informed of the true nature of the research and were even
deprived of penicillin when it was found to be an effective
treatment.
Scientists are working on helping people understand the benefits
of vaccines. A recent survey by the Pew Research Center found that
just over half of Black adults would be willing to get a safe and
effective Covid-19 vaccine, compared with about three-quarters of
white adults.
"The biggest thing is trust-building," said Dr. Kawsar Talaat,
assistant professor in the department of international health at
the Johns Hopkins Bloomberg School of Public Health. "If you give
people information, recruitment is not so hard."
The government's "lack of leadership and clear messaging around
Covid in general has further eroded whatever trust there was in the
public-health system," said Dr. Toyin Ajayi, Chief Health Officer
of Cityblock Health, a health-care provider focused on underserved
communities. To overcome the mistrust, researchers are strategizing
with community groups and churches.
The National Black Church Initiative, which includes about
150,000 U.S. churches, is working with Moderna Inc. after
contacting the drugmaker about collaborating on enrollment. Pastors
will help educate church members about vaccines and encourage them
to enroll, said Rev. Anthony Evans, president of NBCI, which has
worked with the industry on more than a dozen trials before
Covid-19.
"We want to be included. We don't want to be thought of
afterward," he said. "And since the disease is impacting the
African-American community greater than any other community, we
demand that."
Researchers are trying to reach potential subjects though
minority physicians, radio shows and community media outlets. They
are making sure advertisements feature minorities, and that medical
pamphlets are translated from English faster than usual.
Companies also are recruiting in areas with high minority
populations.
In McAllen, Texas, along the Mexican border, where about 85% of
the population is Hispanic, Headlands Research's Centex Studies is
enrolling study subjects for vaccine trials.
"You need to go where the population is," said Headlands Chief
Executive Mark Blumling, whose company is seeking 9,000 subjects
across several sites to test vaccines.
Sanofi SA, which expects to test its first Covid-19 vaccine in
humans in September, will try to reach minorities by conducting
late-stage testing in Latin America, Europe and Asia, said Sanjay
Gurunathan, who oversees vaccine trials at the French company.
Vaccines tested in partnership with the NIH, such as Moderna's
and AstraZeneca PLC's, will harness research sites that are part of
longstanding networks that were used to test HIV vaccines, and have
years of experience recruiting minorities through community
outreach, said Larry Corey, an infectious-disease specialist at the
Fred Hutchinson Cancer Research Center in Seattle, who is advising
the NIH on its vaccine trials.
On Sunday at New Jerusalem Baptist Church in Cincinnati,
researchers from Cincinnati Children's Hospital Medical Center
explained to the congregation the importance of Black Americans'
enrolling in vaccine trials. Afterward, Pastor Damon Lynch Jr.
asked the congregants to tell others. "When you leave, you go out
and you tell them what you learned today," he said. "We want you,
when this stuff becomes a reality, to fight to get it to our
communities."
Sarah Krouse contributed to this article.
Write to Jared S. Hopkins at jared.hopkins@wsj.com
(END) Dow Jones Newswires
August 05, 2020 05:44 ET (09:44 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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