June 2021 • DALLAS MEDICAL JOURNAL 15
awareness and information may limit
participation. For example, some research6
suggests that physicians are less likely to
discuss clinical trials with patients of color.
Further, enrollment efforts may not effectively
reach people of color if they are not
culturally appropriate and do not address
differences in language and health literacy.
Moreover, the medical system’s historic
abuse and mistreatment7 of people of
color, including but not limited to the
infamous Tuskegee syphilis experiment, as
well as ongoing racism and discrimination8
in health care today, may contribute to
less willingness among people of color to
participate in clinical trials.
What steps are being taken
to increase racial diversity
within clinical trials?
There have been ongoing efforts9 to
increase diversity in clinical trials broadly
and specifi c to development of COVID-19
vaccines. The Federal Drug Administration3
(FDA) is engaged in a range of efforts
to encourage greater diversity in clinical
trials, including creating a public-facing
education and outreach campaign, and
working with varied stakeholders. It also
developed recommendations10 to industry
and agency staff on how to collect race
and ethnicity data in clinical trials. The
National Institutes of Health (NIH) has
longstanding guidelines11 on the inclusion
of women and minorities as subjects
in clinical research. In addition to these
general guidelines, there have been specifi
c efforts focused on COVID-19 vaccine
trials. For example, in June 2020, the FDA
offered nonbinding recommendations12 to
the industry on development and licensure
of COVID-19 vaccines that strongly encouraged
the “enrollment of populations most
affected by COVID-19, specifi cally racial
and ethnic minorities.” Both Pfi zer13 and
Moderna have said they worked to ensure
that people of color were included in their
trials, with Moderna even slowing down
enrollment14 to try to enroll more racial and
ethnic minorities. There have also been efforts
on the community side. For example,
historically Black colleges and universities15
are participating in COVID-19 vaccine
trials and encouraging participation among
their communities.
How diverse are
participants in COVID-19
vaccine trials?
Pfi zer-BioNTech and Moderna have
reported the racial/ethnic composition
of the participants in the late-stage
clinical trials for their COVID-19 vaccines.
Pfi zer-BioNTech and Moderna provided
demographic data for participants in
their late-stage clinical trials, including
racial/ethnic composition, as part of
their emergency use authorization (EUAs)
applications to the FDA. These data
show that, overall, people of color are
underrepresented in these trials relative
to their share of the total U.S. population
(Table 1), with the largest disparity among
the Black population. While the trials have
not included the overrepresentation of
people of color that some had suggested,
as noted above, these trials have achieved
greater diversity than many previous trials
for other drugs. In both COVID-19 trials,
the demographics of the placebo and
vaccine groups are similar, as are the
characteristics between all participants
and the safety populations (the group
of individuals receiving the vaccine and
followed for safety). In addition, similar
vaccine effi cacy results were observed
across racial and ethnic groups in both the
Pfi zer16 and Moderna17 trials.
What are implications
of diversity in COVID-19
vaccine trials for
vaccination efforts?
These data show that although people of
color are underrepresented in the clinical
trials for the two initial COVID-19 vaccines
compared to their share of the population,
the trials include people from diverse
racial/ethnic backgrounds and are more
diverse than some trials have historically
been. The fi ndings showing that vaccine
safety and effi cacy were similar for people
of color and White participants could help
increase confi dence in willingness to get
the vaccine, particularly among Black
adults who are more likely than White
adults to point to concerns about safety
and side effects as major reasons2 for
why they probably or defi nitely would not
get the vaccine. As such, information on
the diversity of participants in the clinical
trials and the trials’ fi ndings on safety
and effi cacy for people of color could be
an important component of outreach and
education campaigns and vaccination
efforts that could help prevent disparities
in vaccination. DMJ
US
Population
Age 16+
Pfi zer-
BioNTech* Moderna
Race/Ethnicity of Participants in
COVID-19 Vaccine Clinical Trials
TOTAL 258 million 40,277 27,817
White
Black
Asian
American Indian/Alaska Native
Native Hawaiian or Other Pacifi c Islander
Hispanic
Non-Hispanic
73.6% 81.9% 79.4%
12.3% 9.8% 9.7%
5.9% 4.4% 4.7%
0.8% 0.6% 0.8%
0.2% 0.2% 0.2%
17.6% 26.2% 20.0%
82.4% 73.2% 79.1%
NOTES: *Pfi zer-BioNTech data are for all participants globally; of which 76.7% are in the United States. Pfi zer results provided for
Phase 2/3 trial, Moderna results for Phase 3 trial. The Pfi zer trial included those ages 16 and older. The Moderna trial included those
ages 18 and older.
SOURCES: Racial/ethnic distribution of total population age 16 or older based on KFF analysis of 2019 American Community Survey
data; FDA, Briefi ng Document: Pfi zer-BioNTech COVID-19 Vaccine (https://www.fda.gov/media/144245/download), December 10,
2020; FDA, Briefi ng Document: Moderna COVID-19 Vaccine (https://www.fda.gov/media/144434/download), December 17, 2020
Authors:
Samantha Artiga (@SArtiga2); Jennifer Kates, PhD (@jenkatesdc);
Josh Michaud, PhD, MHS (@joshmich); and Latoya Hill
(@hill_latoya), Racial Diversity within COVID-19 Vaccine Clinical
Trials: Key Questions and Answers, (KFF, January 26, 2021)
https://www.kff.org/racial-equity-and-health-policy/issue-brief/
racial-diversity-within-covid-19-vaccine-clinical-trials-key-questionsand
answers/ (accessed May 3, 2021).
References:
1. https://www.kff.org/policy-watch/racial-disparities-fl u-vaccination
implications-covid-19-vaccination-efforts/
2. https://www.kff.org/coronavirus-covid-19/report/kff-covid-
19-vaccine-monitor-december-2020/
3. https://www.fda.gov/consumers/minority-health-and-healthequity/
racial-and-ethnic-minorities-clinical-trials
4. https://www.nejm.org/doi/full/10.1056/NEJMp2021971
5. https://www.cnn.com/2020/08/29/health/moderna-coronavirus
vaccine-minorities-goal/index.html
6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5131730/
7. https://books.google.com/books?hl=en&lr=&id=q0bMejttqgE
C&oi=fnd&pg=PA1&ots=wb0EUbhrp7&sig=C16I6wxngKSDNcMs
okJa6Dx6gsw#v=onepage&q&f=false
8. https://www.kff.org/report-section/kff-the-undefeated-surveyon
race-and-health-main-fi ndings/#HealthCareSystem
9. https://www.fda.gov/consumers/consumer-updates/fdaencourages
more-participation-diversity-clinical-trials
10. https://www.regulations.gov/document/FDA-
2016-D-3561-0001
11. https://grants.nih.gov/policy/inclusion/women-and-minorities/
guidelines.htm
12. https://www.fda.gov/media/139638/download
13. https://www.marketplace.org/2020/11/09/why-pfi zer-saysit
pushed-for- transparency-and-diversity-in-vaccine-developmentprocess/
14. https://www.cnbc.com/2020/09/04/moderna-slowscoronavirus
vaccine-trial-t-to-ensure-minority-representation-ceosays.
html
15. https://theundefeated.com/features/president-of- morehouse
school-of-medicine-has-life-or-death-message-for-blackpeople
about-the-coronavirus- vaccine/
16. https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
17. https://www.nejm.org/doi/full/10.1056/NEJMoa2035389