Name: Bay Area volunteers can now sign up for large coronavirus vaccine trials
Brand: eastbaytimes.com
SKU: eastbaytimes-com-61
Availability: OnlineOnly

critic

Bay Area volunteers can now sign up for large coronavirus vaccine trials

preview

By | | Bay Area News GroupWith 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.Clinical trials 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’s 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 a fast-tracked vaccine was ready for widespread use, but its accelerated evaluation raised safety concerns 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 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.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 temporary approval based on interim data, through emergency authorization, rather than waiting for the end of the two-year-long 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 also will 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.That phase 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.”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.&nbsp; Only Kaiser members are eligible to participate..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 such as 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 health care 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 can be found at To find it, go to the search bar and type in COVID Vaccine. Click on ‘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 website, created by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, helps connect volunteers to vaccine studies. To register as a potential volunteer, you will be asked to complete a 10-minute online survey, which asks some personal questions.The website , with one of the largest clinical trial databases on the internet, also lists COVID-19 research projects.Go to: Under “Search Medical Condition,” type COVID-19 vaccine.There’s no guarantee that you’ll actually be protected from the virus at any phase of a vaccine trial.. It you are adversely affected by an experimental vaccine, the developers have committed to reimbursing your health insurance company.“This one is new and scary. It may work and may not work,” said Eisenman.“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.”We invite you to use our commenting platform to engage in insightful conversations about issues in our community. We reserve the right at all times to remove any information or materials that are unlawful, threatening, abusive, libelous, defamatory, obscene, vulgar, pornographic, profane, indecent or otherwise objectionable to us, and to disclose any information necessary to satisfy the law, regulation, or government request. We might permanently block any user who abuses these conditions.Get Morning Report and other email newslettersFollow UsMost PopularClose

By | | Bay Area News GroupWith 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...

public

Lisa M. Krieger

Winner of the 2017 Pulitzer Prize for Breaking News Reporting. See the latest news from throughout the East Bay, including Contra Costa and Alameda counties.

Bay Area volunteers can now sign up for large coronavirus vaccine trials

No article scores yet.

CRITIC REVIEWS

PUBLIC REVIEWS