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 Branche and colleagues at the University of Rochester Medical Center
in New York were running a clinical trial for a vaccine against the
coronavirus, which kills Black people at three times the rate it
kills whites - yet it was mostly whites signing up. They needed more
African Americans.
Unbeknownst to Branche, five miles away in Rochester’s poorest zip
code, ordained minister Marsha Allen was planning a door-knocking
campaign to educate residents of the mostly Black neighborhood about
the virus that has killed more than 420,000 Americans.
Both women are Ivy League-educated and Black, but they exist in
different orbits - one in the halls of science, the other in
often-forgotten communities. Mutual connections brought them
together, and in July, the pair formed an alliance: Branche’s team
would help with COVID-19 education, and Allen would recruit Black
participants for the vaccine trial - starting with herself.
“Doctors can't come in here with their white suits and needles - no
one will listen,” said Allen, leader of an organization called the
Global Humanitarian Surround Care Mobile Wellness Initiative, whose
work before the pandemic included outreach in Haiti. In Rochester,
where Allen runs a community garden, she is known as Sister Marsha.
The blueprint Branche and Allen followed for the ongoing AstraZeneca
Plc trial is becoming increasingly common across the United States
for COVID-19 vaccine outreach. Often led by doctors and scientists
of color, the efforts rely heavily on grassroots partners such as
churches and health centers, and aim to topple long-standing
barriers that keep minorities from participating in clinical trials.
The initiatives could change the way vaccine and drug trials are
conducted in the United States, according to Reuters interviews with
more than 40 public health and pharmaceutical-industry officials.
"This mindset about diversity - of not just being an afterthought
but a central part of successful trials - is beginning to sink in,"
Dr. Francis Collins, director of the U.S. National Institutes of
Health (NIH), told Reuters.
Enrollment of Black people in clinical trials is a particular
challenge. Mistrust runs high, in part because of the nation’s
history of unethical practices in medical research on African
Americans.
Melanie Campbell, who runs a Washington, D.C.-based nonprofit
focused on Black civic participation nationwide, nearly died of
COVID-19 last year, spending three weeks in intensive care. Although
she sees the need to set an example, she still has reservations
about the shot.
“I don’t know one (Black) person who isn’t afraid of this frigging
vaccine,” she said.
Before now, Black people have accounted for an estimated 3% to 5% of
enrollees in vaccine trials, although they make up about 13% of the
U.S. population, researchers say. In COVID-19 vaccine trials, their
participation so far is up to 10%, according to vaccine
manufacturers.
Unless vaccines are thoroughly tested among Blacks, many will skip
the shots, medical experts say.
That’s a problem because African Americans are more likely to
contract the coronavirus. They more often live in crowded housing
and work face-to-face with the public, raising the risk of
infection. They also have higher rates of chronic conditions such as
diabetes and less access to good medical care, factors which can
complicate treatment and decrease odds of survival.
Branche said that’s a big reason why the NIH and pharmaceutical
companies have essentially told researchers like her: Increase
African American enrollment - or risk having your vaccination site
shut down.
FROM THE TOP
It was July 4th, U.S. Independence Day. But it was no holiday for
NIH director Collins. Clinical trials by vaccine makers Moderna Inc
and Pfizer Inc were due to start soon, and Collins feared that
minority recruitment would lag.
Collins said he hastily convened a conference call, summoning NIH
officials and advisers involved in Operation Warp Speed, the
government’s $12.4 billion program overseeing COVID-19 vaccine
trials.
He and other call participants recalled his message as blunt. “It’s
not just a nice idea,” Collins told Reuters. “It's not just like,
‘Well, yeah, diversity is important.’ This is critical for the
scientific credibility of these trials."
The result was an NIH diversity initiative led in part by Dr. Gary
Gibbons, a Black physician who heads the U.S. National Heart, Lung
and Blood Institute (NHLBI).
The $12 million initiative finances research teams in 11 states that
hold focus groups in minority communities to formulate vaccine
messaging campaigns and promote trial participation. The effort also
brings together the often-siloed institutes and centers within NIH
that have established ties to communities of color.
[to top of second column] |
 Greg Millett, an AIDS
researcher who sits on an exclusively African
American scientific advisory board for
coronavirus vaccine trials, likened the effort
to early HIV prevention messaging in hard-hit
Black communities. That and other public health
campaigns have relied on community leaders, such
as pastors and barbers. The
COVID-19 outreach efforts have helped to double the historic rate of
participation by Black people in vaccine trials. Some researchers,
however, say Blacks’ participation should exceed their share of the
U.S. population, given the outsized impact of COVID-19 in this
group.
Among the two companies with vaccines already on the U.S. market,
Moderna Inc said 10% of U.S. trial volunteers were Black - a level
reached only after the company slowed trial enrollment in September
to improve African American participation. Pfizer Inc said its Black
enrollment was 9%.
Moderna Chief Executive Officer Stephane Bancel told Reuters the
company had closed some test sites where minority representation
fell short. “If some important subpopulation has worries and
questions about the safety and efficacy of the vaccine … we will not
have succeeded,” Bancel said.
AstraZeneca said on Wednesday it had completed trial enrollment with
9.8% African American participation.
To meet its enrollment targets, Johnson & Johnson enrolled only
minorities and elderly people in the final days of its U.S. trials,
Chief Scientific Officer Paul Stoffels told Reuters. He did not
provide statistics but said the company eventually met “all of our
objectives” for minority enrollment.
“It took longer than we expected to get people comfortable with
joining the study,” Stoffels said.
REASONS FOR SKEPTICISM
Boosting minority enrollment is complicated by historical mistrust,
especially among Black people.
During the infamous Tuskegee Syphilis Study last century, government
researchers left hundreds of Black men untreated for decades to
study the disease’s debilitating and sometimes deadly effects. And
in 1951, tissues taken without consent from a Black cancer patient
in Baltimore were used to create a cell line used for myriad medical
experiments - a well-known ethical breach.
Today, the mistrust extends to vetted COVID-19 vaccines, not to
mention vaccine trials. A Reuters/Ipsos poll in December showed just
49% of Black Americans would be interested in being vaccinated, 14
points below whites’ level of interest.
Rochester resident Edwina Killings, 58, recently spoke to Reuters
from a hospital bed, battling a severe case of COVID-19. Gasping for
air, Killings recalled how, weeks earlier, Sister Marsha Allen had
offered to enroll her in the Rochester trial. She declined.
“I wanted to see how it worked on other people first,” said
Killings, who is back home but still on oxygen.
Focus groups led by the University of Kentucky’s Lovoria Williams
found Black respondents skeptical partly because of the speed of
coronavirus vaccine development. However, the focus groups showed
that ads depicting researchers of color could help mitigate the
mistrust, said Williams, co-director for special populations at the
university’s Center for Clinical and Translational Science.
Williams, whose work is funded by NIH, shares her intel with
community leaders like Michael Minor, a Baptist pastor and health
advocate in DeSoto County, Mississippi. Minor made national
headlines when he was honored by then-First Lady Michelle Obama in
2009 after banning fried chicken, which is high in fat, calories and
salt, at church functions.
More recently, the pastor, whose county has the most COVID-19 cases
in the state, sent his congregation text blasts with links to
articles about the dangers of skipping vaccination.
Recruiting people to help test vaccines is a steeper challenge.
Allen said success depends on including people like her, not just as
messengers but as leaders every bit as important as researchers like
Branche.
“It’s not like dropping food out of an airplane in a poor country,”
Allen said. “You have to work to get people on board. What’s the
point of investing in a vaccine if the people don’t want it?”
(Julie Steenhuysen reported from Chicago, Nick Brown from New York.
Editing by Michele Gershberg and Julie Marquis
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