By Rolfe Winkler and Jared S. Hopkins
Dr. Victoria Smith had lost three patients to Covid-19, while
another patient had lost her husband and brother to the virus. So
when the New Orleans-area family physician learned in July that her
health system would participate in a vaccine trial, she was in the
lab to get her first dose the next day.
The trial that Dr. Smith entered, for Pfizer Inc.'s experimental
Covid-19 vaccine, seems a lot like any other medical study. There
is paperwork, blood work and a pair of shots three weeks apart. She
keeps a diary of how she is feeling to share with researchers. She
has been paid about $400 so far. And yet the stakes make the
Covid-19 vaccine trials unique.
"Being part of a trial to develop a vaccine is what's going to
help us get back to any sense of normalcy," said Dr. Smith, who is
52 years old. "Because a vaccine is how you really end this
Tens of thousands of Americans are already participating in
Phase 3 Covid vaccine trials, while thousands more will be
recruited for additional trials beginning soon. They are the tip of
the spear in the global fight against the virus, and many of them
say they are eager to help people return to their normal lives and
disabuse vaccine skeptics.
"The sheer number of Covid-19 vaccine trials in such a
concentrated amount of time is unlike anything that I have seen
before," said Mark Blumling, chief executive of Headlands Research.
"This is also reflected in the unparalleled enthusiasm" among
potential trial enrollees, he added.
Headlands is conducting Covid-19 vaccine trials for Pfizer and
Moderna Inc. and is planning trials for vaccine candidates from
AstraZeneca PLC and Novavax Inc.
The vaccines are being developed quickly thanks in part to the
rapid mapping of the coronavirus genome and new vaccine-making
In interviews, vaccine-trial participants described a typical
trial-enrollment process: a screening phone call, and if they are
approved, a three-to-four-hour appointment at a trial research site
where participants give detailed medical histories. They give
blood, get tests -- including a pregnancy test for women -- and
then receive their first shots. They are observed for 30 minutes to
make sure they don't have a bad reaction. Many trial participants,
including those in the Pfizer and Moderna studies, use a smartphone
app to keep a diary of any symptoms.
As with many clinical trials in the U.S., participants in the
Covid vaccine trials are paid a modest amount, depending on the
number of doctor appointments, follow-up calls and other
requirements of the studies.
Americans are the primary guinea pigs in part because the U.S.
has had a hard time controlling infections, said Mr. Blumling. It
is easier to gather data on a vaccine's efficacy if trial
participants are regularly exposed to the virus, and researchers
including Headlands are recruiting subjects who venture out of
their homes to work as well as those who live in Covid hot spots.
Volunteers tend to be healthy and white, so Headlands is also
looking for people with pre-existing conditions as well as those
from diverse racial and age groups who have been hit harder by the
One such group was Louisiana's Black population, as Dr. Smith
knows all too well.
"Covid is disproportionately impacting African-Americans," said
Dr. Smith, who is Black. "I wanted to be a model to the
African-American and Latino community that this is safe and
something for you to think about."
Many of Dr. Smith's minority patients are skeptical of clinical
research, especially those familiar with the infamous Tuskegee
experiments, in which Black men with syphilis were studied and
tracked for 40 years without their knowledge and not given adequate
"My participation and dialogue [with patients] is to explain the
difference between this kind of trial and what happened with
Tuskegee," she said.
Brad Hoylman, a 54-year-old Pfizer-trial participant, has dealt
with intense vaccine skepticism. A state senator from New York, Mr.
Hoylman sponsored legislation that removed a religious exemption
for vaccinating schoolchildren, following New York's 2019 measles
Vaccine opponents had hounded his staff and his family before
Covid, and when he posted photos of himself receiving Covid vaccine
shots in August, the internet trolls were waiting. "May your family
suffer for eternity," tweeted one person over a manipulated photo
of Mr. Hoylman with a knife held to his neck.
Covid vaccine trials are standard, double-blind studies. For
most trials, half of participants receive the vaccine candidate and
the rest get a placebo. Participants don't know which they receive
because researchers want both halves of the study to continue their
normal routines and expose themselves to Covid. If more people with
the placebo are infected, that demonstrates the vaccine provides
It takes time for data to prove that the vaccine provides at
least some immunity and then more time to determine duration of
immunity, which is why study participants will be monitored for two
President Trump has said a vaccine could be ready as early as
this month. "The vaccines are coming momentarily," he said this
week. Such predictions contradict experts in his administration,
including the director of the Centers for Disease Control and
Prevention, who said in September that even if a vaccine is
available, it will take six to nine months to get all Americans
Nine pharmaceutical companies working on vaccines signed a
pledge in September to "uphold the integrity of the scientific
process" as they work toward regulatory approval for Covid-19
vaccines. Pfizer executives have said they expect to see trial
results and file for an emergency authorization this month.
To receive emergency authorization, the Food and Drug
Administration said Tuesday, a vaccine must be 50% effective,
roughly the same as the annual flu shot, meaning that trial
recipients who received the experimental vaccine develop no more
than half as many Covid cases as those that received a placebo.
Mr. Hoylman said he doesn't want a vaccine rushed. While he
can't be sure he received the vaccine instead of a placebo, he said
he experienced side effects, including a fever, severe body aches,
chills and a migraine headache the day after his second shot. Such
symptoms are normal for vaccines, and Mr. Hoylman recovered
When asked about its vaccine, Pfizer referred to its September
R&D day presentation, in which it said that in an early-stage
study the vaccine was well-tolerated "with only mild-to-moderate
events and low incidence of fever and chills in older adults."
"There's vaccine hesitancy in this country," said Dr. Judith
Aberg, who is running the trial for Pfizer at New York's Mount
Sinai Hospital. "If we roll out a vaccine and it doesn't work, and
people get Covid, that's not helping anyone. We need to assure
people that it's going to be safe and it's going to work."
A key difference with Covid vaccines is that some leading
candidates use unproven technology. Vaccines are simulated
infections that induce an immune response. Most vaccines use an
inactive or weakened virus. The Pfizer and Moderna "mRNA" vaccines
are designed to deliver genetic material to human cells to make
proteins that, in turn, trigger the immune system to defend against
the coronavirus. The vaccines from AstraZeneca and from Johnson
& Johnson use a common-cold virus to deliver genetic
instructions teaching the human immune system to mount a
AstraZeneca halted new-patient enrollment for its trial in early
September after a woman in the U.K. experienced an unexplained
illness, which a U.S. official described as a spinal-cord problem.
An AstraZeneca spokesman said the company's trial has resumed in
the U.K., Brazil and South Africa, but not yet in the U.S. He
declined to discuss details of the illness in the patient that
precipitated the pause.
William Relton, a 63-year-old opera director from London, got
his first dose of AstraZeneca's experimental vaccine or a placebo
in late August, just days before the trial was suspended. He said
he hasn't experienced side effects, but he said the trial's halt
didn't give him a moment's pause about getting his second dose
later in September.
"I think it's the right thing to continue the trial," he said.
"I already had one shot, so a second wouldn't do a lot of
Like other trial participants, Mr. Relton will dedicate
significant time to the trial. He has committed to giving himself
throat and nasal swabs weekly for a year to determine whether he
has caught Covid. A vaccine, he said, is the only way everyone will
be able to return to normal lives. "I want to do whatever I can to
help," he said.
Write to Rolfe Winkler at email@example.com and Jared S.
Hopkins at firstname.lastname@example.org
(END) Dow Jones Newswires
October 08, 2020 09:14 ET (13:14 GMT)
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