Ensuring racial and ethnic diversity
in clinical trials for development of
COVID-19 vaccines is particularly
important since COVID-19 has
taken a heavy disproportionate toll on
people of color, and people of color,
particularly Black adults, historically
have had lower vaccination1 rates and
express more concerns2 about getting
a COVID-19 vaccine compared to their
14 DALLAS MEDICAL JOURNAL • June 2021
White counterparts. Diversity within
clinical trials for a COVID-19 vaccine helps
ensure safety and effectiveness across
populations and may increase confidence
in getting the vaccine among people of
color. Historically, people of color have
been underrepresented3 in clinical trials.
There have been recent efforts to increase
racial diversity within clinical trials, and
specific efforts to increase diversity within
the trials associated with development of
COVID-19 vaccines. With two COVID-19
vaccines now authorized in the U.S. (the
Pfizer-BioNTech and Moderna vaccines), we
review why racial diversity within COVID-19
vaccine clinical trials is important, discuss
the barriers to participation in clinical trials
among people of color, and examine the
racial/ethnic composition of clinical trial
participants for the Pfizer-BioNTech and
Moderna vaccines.
Why is it important to
have diversity within the
COVID-19 vaccine trials?
Diverse racial/ethnic representation
in COVID-19 vaccine trials is important
because drugs and vaccines can differentially
affect groups reflecting variation in
underlying experiences and environmental
exposure. Clinical trials3 are research studies
that determine whether medical products
like medicines, vaccines, or devices
are safe and effective. It is important for
participants in clinical trials to represent
the patients that will be using the medical
products since responses may vary across
patient groups.
In general, to be representative, vaccine
trials should enroll people of color in
percentages similar to their representation
in the population. However, since people
of color have been disproportionately affected
by COVID-19 pandemic, scientists4,
including Dr. Anthony Fauci5, have indicated
that the COVID-19 vaccine trials should
overrepresent people of color compared to
their population share.
Why are people of color
underrepresented in clinical
trials?
Access barriers, lack of information, and
historic and ongoing racism and discrimination
contribute to underrepresentation of
people of color in clinical trials. People of
color face an array of structural access-related
barriers to participating in trials. For
example, fewer clinical trials6 are available
through under-resourced hospital systems
where people of color are more likely to
receive care, and people of color may be
less likely to be eligible to participate in
trials if being uninsured or having co-morbidities
excludes individuals from participation.
Other access challenges, such as
prohibitive distance to trial sites for people
with limited transportation options, limited
flexibility in work and caregiving schedules,
and lack of access to technology for monitoring
that may be required as part of the
trial also may increase barriers to participation
among people of color.
Beyond these challenges, lack of
ADVOCACY
Racial Diversity
Within COVID-19
Vaccine Clinical
Trials: Key Questions
and Answers
By Samantha Artiga; Jennifer
Kates, PhD; Josh Michaud, PhD,
MHS; and Latoya Hill