With one injection, Dusta Eisenman and other Bay Area volunteers
are joining the unprecedented search for a COVID-19 vaccine, eager
to help end the worst pandemic in a century.
“I wanted to do my part and be a team player, to get people
back to working, people healthy and kids back at school,” said
Eisenman, 44, a San Jose mother of three and Kaiser pediatric
nurse.
Kaiser’s study of a Pfizer vaccine, launched at their Santa
Clara and Sacramento facilities on Monday, represents the beginning
of several trials in the San Francisco Bay Area – part of a vast
network of more 100 test sites around the globe in the most
consequential race for disease prevention in recent medical
history.
Next week, UCSF and San Francisco’s Department of Public
Health will announce the launch of their study of an AstraZeneca
vaccine. That same vaccine will also be tested at Alta Bates Summit
Medical Center in Oakland.
Stanford Healthcare expects to participate in two vaccine
trials, still unnamed. The first will begin in September, followed
by the second in October.
It’s a gargantuan undertaking. To get the data needed to prove
whether a coronavirus vaccine is safe and effective enough to be
given to tens of millions of Americans, each trial must recruit
tens of thousands of volunteers. Half to two-thirds of participants
get the vaccine; the other half, in a “control” group, get an
inactive placebo.
Research
Nurse in Clinical Trials, Jessica Barraza, left, instructs Dusta
Eisenman, one of the vaccine volunteers, to look away when given
the vaccine because the subject is not allowed to see the syringe
which has identifying labels on it. Volunteers cannot know if they
got the vaccine or the placebo in the study. (Courtesy of Kaiser
Permanente)
The trial must continue until a percentage of individuals in the
control group become infected. Because most people are taking steps
to protect themselves, it is impossible to predict precisely how
long that will take.
Faster recruitment means faster results – and faster federal
approval, manufacturing and distribution. And fewer deaths.
If all goes smoothly, the earliest we’ll likely see meaningful
data will be mid to late fall, said Dr. Peter Marks, who oversees
the U.S. Food and Drug Administration’s team of experts charged
with evaluating coronavirus vaccine candidates.
The latest might be the first part of 2021, he said.
The FDA may make its decision based on interim data, rather than
waiting for the end of the two-year studies.
Overall, a total of 150 to 160 coronavirus infections in the
study will be enough to determine whether the vaccine is acceptably
effective — that is, if it protects at least 50 percent of those
who receive it. Scientist will also evaluate whether it lessened
the severity of the disease in the test group.
Before approval, vaccines go through a phased system of trials.
The initial tests, which assess safety and dosage, involve just a
few hundred people.
The more conclusive and ultimate phase of study – now underway
in the Bay Area – involves up to 30,000 people each.
Each trial costs hundreds of millions of dollars. To support the
accelerated effort, the federal government is helping bankroll the
projects, said Dr. Paul A. Offit, professor of vaccinology at the
University of Pennsylvania School of Medicine.
“That’s shortening the timeline,†said Offit, a pioneer in
the field of virology and immunology. “There’s never been more
money or more interest or more ideas on how to make a
vaccine.â€
In the Kaiser trial, volunteers are asked to keep a diary of
symptoms and are followed by phone calls and telemedicine,
according to Dr. Nicola Klein, director of the Kaiser Permanente
Vaccine Study Center and principal investigator for the trial in
Northern California.
Five times over the next two years, scientists will study blood
from Eisenman and other volunteers for any sign that the vaccine
triggered an immune response — and, if so, the vigor of that
response, and whether it is protective.
That would offer the first proof that the vaccine could provide
immunity from a disease that has claimed more than 750,000 lives
worldwide.
Volunteers may experience minor and transient side effects like
sore arms, fatigue, achiness and fever.
Scientists are particularly interested in testing people who are
at high risk for exposure to the COVID-19 virus, such as healthcare
workers, she said. They also are seeking people with underlying
medical conditions or who belong to racial or ethnic groups that
are disproportionately suffering from disease, such as Latinx,
Black or Native Americans.
Volunteers are not injected with the virus.
The Pfizer vaccine, developed with the German company BioNTech,
uses a synthetic version of genetic material, called messenger RNA
or mRNA, from part of the coronavirus. It enters human cells –
and the body’s immune system, recognizing it as foreign, launches
an attack. So if the person is later exposed to the real virus, the
body is primed to defend it.
The AstraZeneca vaccine takes a different approach. It uses a
modified form of a different virus to carry part of the virus,
called a spike protein, into the body. When the body detects this
protein, it triggers an immune response.
Want to volunteer? More information about the Kaiser trial can
be found at http://kpstudysearch.kaiser.org.
The Covid-19 Prevention
Network website, created by the National Institute of Allergy
and Infectious Diseases at the National Institutes of Health, helps
connect volunteers to vaccine studies. ClinicalTrials.gov also lists
COVID-19 research projects.
There’s no guarantee that you’ll actually be protected from
the virus at any phase of a vaccine trial.
“This one is new and scary. It may work and may not work,â€
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“But I have seen the power of vaccines,†she said. As a
nurse and vaccine advocate, “I should be the one putting my
actions where my mouth is.â€
