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1,000 Volunteers Enroll at Stanford for COVID Vaccine Trial

At least one coronavirus vaccine is expected to receive FDA emergency use authorization and be made available early next year to some high-risk individuals like health-care workers and nursing home residents, employees.

by Catherine Ho, San Francisco Chronicle / November 4, 2020

 Nov. 3—Stanford Medicine has begun enrolling volunteers to participate in a clinical trial for a coronavirus vaccine developed by Johnson & Johnson — one of a handful of efforts considered front-runners in the global race for a vaccine.

Enrollment for Phase 3 of the trial began Friday, marking the final stage before potential authorization in which tens of thousands of people receive the vaccine to see if it is effective. Stanford plans to enroll 1,000 volunteers as part of the global trial that will include 60,000 people at 180 sites around the world.
At least one coronavirus vaccine is expected to receive FDA emergency use authorization by the end of the year and be made available early next year to a small number of high-risk individuals like health care workers and nursing home residents and employees. But vaccines will probably not be widely available for most of the U.S. population until summer or fall 2021, according to estimates from scientists, including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
Participants will receive the vaccine or a placebo and be followed for two years. Stanford is particularly interested in volunteers who are at higher risk for contracting the virus, including teachers, grocery store workers, people who live in multi-generational households, health care workers and students.
The Johnson & Johnson trial was paused and restarted in the United States in October because of an unexplained illness in one trial participant.
It is one of several large coronavirus vaccine trials under way in the Bay Area. Kaiser Permanente is participating in clinical trials for the Pfizer vaccine in Santa Clara and Sacramento counties. Bridge HIV, a research unit at the San Francisco Department of Public Health, is enrolling volunteers for the AstraZeneca vaccine trial. All are part of global Phase 3 vaccine trials, and the Bay Area sites are among the dozens of U.S. sites enrolling volunteers to receive the vaccines.
The Johnson & Johnson vaccine consists of one dose and does not have to be kept at ultra-cold temperatures like the Pfizer vaccine, which requires two doses and must be stored at minus-70 degrees Celsius.
So far, three people have participated in the Johnson & Johnson vaccine trial at Stanford, and the hope is to eventually enroll 15 to 20 people a week, said Dr. Philip Grant, an assistant professor of infectious disease at Stanford and the site principal investigator. The trial is a randomized, double-blinded, placebo-controlled study — so neither the participants nor the researchers know who got the vaccine and who got the placebo.
Walter Sobba, the first participant in the trial at Stanford, said he volunteered to help advance scientific understanding of the coronavirus.
"If I can go and volunteer and allow my experience to contribute to science and the progression of knowledge about this disease, I'm happy to do that," said Sobba, 23, a research assistant who lives in San Francisco. "In our current environment, there's a lot of rhetoric about the current scientific process, and I just wanted to see if there's a way to build trust between the scientific community and the greater population through my experience."
Those interested in participating in the Johnson & Johnson trial can visit
Catherine Ho is a San Francisco Chronicle staff writer. Email: Twitter: @Cat_Ho
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