With one injection, Dusta Eisenman and other Bay Area volunteers join the unusual search for a COVID-19 vaccine, envied to help end the worst pandemic in a century.
“I wanted to do my part and become a team player, to get people back to work, healthy people and kids back to school,” said Eisenman, 44, a mother of three in San Jose and granddaughter of Kaiser.
Kaiser’s study of a Pfizer vaccine, launched Monday at its Santa Clara and Sacramento facilities, represents the start of several trials in the San Francisco Bay Area – part of a large network of more than 100 test sites around the world in the most consistent race for disease prevention in recent medical history.
Clinical studies are critical indicators of whether a vaccine is safe and effective. Globally, more than 30 vaccine candidates in more than a dozen countries have reached this stage. Experts warn that it is too early to determine which, if any, will be successful. The Chinese military approved one of these for limited use. And this week, Russia announced that a fast-track vaccine was ready for widespread use, but its accelerated evaluation raised concerns about security in the West.
Next week, UCSF and San Francisco’s Department of Public Health will announce the launch of their study of an AstraZeneca vaccine.
Stanford Healthcare expects to participate in two fax tests, not yet named. The first will begin in September, followed by the second in October.
It’s a gigantic enterprise. To obtain the data needed to prove whether a coronavirus vaccine is safe and effective enough to feed tens of thousands of Americans, each trial must recruit tens of thousands of volunteers. Half to two-thirds of participants receive the vaccine; the other half, in a ‘control group’, receive an inactive placebo.
The trial should continue until a percentage of individuals in the control group are infected. Because most people take steps to protect themselves, it is impossible to predict exactly how long that will take.
Faster recruitment means faster results – and faster federal approval, manufacturing and distribution. And less dead.
If all goes well, the earliest are likely to see significant data until mid to late fall, said Dr. Peter Marks, who oversees the team of U.S. Food and Drug Administration experts tasked with evaluating candidates for coronavirus vaccine.
The latter may be the first part of 2021, he said.
The FDA can grant temporary approval based on interim data, via emergency authorization, instead of 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. Scientists will also evaluate whether it reduced the severity of the disease in the test group.
Prior to approval, faxes go through a phased system of trials. The initial tests, which assess safety and dosage, involve only a few hundred people.
The more conclusive and final phase of study – which is now beginning in the Bay Area – each involves up to 30,000 people.
That phase will cost 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 faxinology at the University of Pennsylvania School of Medicine.
“That shortens the timeline,” said Offit, a pioneer in the field of virology and immunology. “There was never more money or more interest or more ideas on how to make a fax.”
In the Kaiser trial, volunteers are asked to keep a diary of symptoms and are followed up by phone calls and telemedicine, according to Dr. Nicola Klein, director of the Kaiser Permanent Vaccine Study Center and lead researcher for the trial in Northern California. Only Kaiser members are eligible to participate.
Five times in the next two years, scientists will study blood from Eisenman and other volunteers for each sign that the vaccine triggered an immune response – and, if so, the potency of that response and whether it is protective.
That would provide the first evidence that the vaccine could provide immunity against a disease that has claimed more than 750,000 lives worldwide.
Volunteers may experience minor and transient side effects such as nausea, 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 health care workers, she said. They are also looking for people with underlying medical conditions or who belong to racial or ethnic groups that suffer disproportionately from disease, such as Latinx, Blacks or Indians.
Volunteers are not infected with the virus.
The Pfizer vaccine, developed with the German company BioNTech, uses a synthetic version of genetic material, called messenger RNA or mRNA, of a 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 another virus to carry part of the virus, a spike protein, into the body. When the body detects this protein, it triggers an immune response.
Do you want to volunteer? More information about the Kaiser trial can be found at http://kpstudysearch.kaiser.org.To find it, go to the search bar and type COVID fax. Click “Northern California.” The study is entitled: “Study to describe the safety, tolerability, immunogenicity and efficacy of RNA vaccine candidates against COVID-19 in healthy adults.”
The Covid-19 Prevention Network website, created by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, helps volunteers connect with vaccine studies. To register as a potential volunteer, you will be asked to complete a 10-minute online survey that asks some personal questions.
The CenterWatch website, with one of the largest clinical trial databases on the Internet, also lists COVID-19 research projects. Go to: https://www.centerwatch.com/ClinicalTrials.gov. Under ‘Find medical condition’, type COVID-19 vaccine.
There is no guarantee that you will actually be protected against the virus at every stage of a vaccine trial. It has been negatively affected by an experimental vaccine, the developers have promised to reimburse your health insurance company.
‘This is new and scary. It can work and maybe not work, ”said Eisenman.
“But I have seen the power of faxes,” she said. As a nurse and vaccine lawyer, “I should be the one to put my actions where my mouth is.”
