34 | OCTOBER 29 • 2020 

type of VIP list. We made 
sure we were prioritizing 
minorities who came from 
our community.”
Black enrollment, especially, 
has been low in the COVID 
vaccine trials, because of the 
community’
s mistrust in the 
American health system after 
such racist medical incidents as 
the Tuskegee experiment.
When the president of Dillard 
University, a historically Black 
college in New Orleans, sent out 
a letter urging the campus com-
munity to consider enrolling 
in a COVID-19 vaccine trial, it 
was met with hundreds of posts 
of fierce backlash over their 
social media platforms.
“Our children are not lab rats 
for drug companies,
” said one 
post. “I can’
t believe a HBCU 
[Historically Black Colleges 
and Universities] would do this 
to our people,
” said another 
response. 
Zenlea couldn’
t give any spe-
cific statistics about Black enroll-
ment in her trial, but said her 
trial was featured on a Moderna 
webinar focused on diversity 
and inclusion, given their status 
as a leader in the area. 
Most clinical trials of a study 
vaccine, especially Phase III 
clinical trials, take about 12-18 
months to set up. The Zenlea-
led Moderna trial was set up in 
less than two months because of 
how active the virus became.
“I think it was about seven 
weeks, start to finish, from our 
enrollment date to when we 
started setting this up,
” she said.

GETTING RESULTS
The Moderna trial runs 24 
months and requires multiple 
in-person visits, COVID swabs, 
blood draws, the injections of 
the study vaccine, and many 
follow-up visits and safety calls 
throughout.
According to Zenlea, an anal-
ysis will be done once Moderna 
has enough people enrolled 
and data gathered where they 

can statistically say whether the 
study vaccine is effective. If they 
determine the study vaccine is 
effective, the study would be 
“called” or “ended,
” those who 
received the placebo would 
receive the vaccine, and the vac-
cine would go to market.
“It is possible that the sponsor 
(Moderna) will have enough 
enrolled participants and 
enough data to determine if 
the study vaccine is effective or 
not before the end of the study 
timeline, which is initially set 
for 24 months,
” Zenlea said.
Zenlea and her team have not 
received any official word that 
the study will be “called” before 
the end of the trial period.
Zenlea will also be the man-
aging director of the Johnson 
& Johnson COVID-19 Phase 
III vaccine trial in Detroit, 
which she initially hoped would 
begin in the next few weeks, 
before news came out on Oct. 
13 that Johnson & Johnson is 
pausing its trial while the com-
pany investigates a participant’
s 
“unexplained illness.
”
Zenlea and her team are 
aware of that issue, and she says 
J&J is investigating the “unex-
plained illness” and has halted 

all study activities, internation-
ally, until they know more. 
“We still have plans to launch 
this trial at our site once the 
safety hold has been lifted, and 
we continue to work closely 
with the sponsor. Of course, we 
will not start any study activities 
until it is completely safe to do 
so,
” Zenlea said.
Adverse events are expected 
in all clinical trials and the J&J 
study is no different, according 
to Zenlea.
“There are several clinical 
indicators that could trigger 
a ‘
study pause,
’
 planned or 
unplanned, and they are always 
investigated in an abundance of 
caution,
” she said.
There are more than 100 
national sites for the J&J trial, 
and their enrollment target col-
lectively is 60,000, about double 
that of Moderna’
s.
Dr. Marc Zervos, head of the 
infectious disease division for 
HFHS and the principal investi-
gator on the Moderna Phase III 
COVID vaccine trial in Detroit, 
knows how important Zenlea 
has been to the trial.
“Kate has remarkably built 
Henry Ford Health System’
s 
COVID vaccine trial from the 

ground up … the work she 
is doing is truly admirable,
” 
Zervos said. “[The vaccine trial] 
is one of the most incredible 
achievements I’
ve ever seen in 
my lifetime, and it is largely due 
to Kate’
s leadership. There are 
very few people in the country 
who could’
ve accomplished 
what she’
s done.
”
The other principal investiga-
tor is Dr. Paul Kilgore, a senior 
scientist with the GHI and fac-
ulty of Wayne State University.

JEWISH VALUES
Zenlea grew up going to 
Temple Beth El in Bloomfield 
Hills and now belongs to 
Congregation Etz Chayim in 
Huntington Woods.
 Zenlea is proud to represent 
her community, along with her 
husband, David, and 1-year old 
daughter, Shoshana.
“It’
s a huge part of our 
identity,” Zenlea said. “To be 
Jewish and to be leading this, 
it just makes me proud that I 
can showcase this as a young 
Jewish professional of what 
our capabilities are and what 
I’
m able to do, and I hope it’
s 
making the community proud 
as well.”
Zenlea also suspects that even 
when the vaccine comes out, 
we’
re still going to be practicing 
social distancing, mask-wearing 
and hand-washing measures for 
some time, due to it taking time 
for everyone to get vaccinated.
She believes caring for one’
s 
community with those precau-
tions runs true to her Jewish 
values as well.
“It’
s not just me; it’
s the 
community,” Zenlea said. 
“We’
re a part of something 
larger. That’
s true if you’
re 
referring to being Jewish or 
if you’
re referring to helping 
to end a global pandemic. 
We’
re all part of a larger 
story, and the story here is 
we have to make sure we’
re 
protecting ourselves and our 
community.” 

continued from page 33

Kate Zenlea’s 

vaccine study 

focuses on 

inclusion of 

the minority 

population.

