Kaiser Permanente in California and Oregon, including locations in Santa Clara and Sacramento counties, participated in a worldwide trial of one of the first coronavirus vaccines to begin large-scale testing in humans, the health care provider announced Wednesday.
The Phase 3 trial, the final step before federal approval, is the first major study to seek out Bay Area volunteers in the dramatic, international race for a coronavirus vaccine. Kaiser on Monday gave the vaccine to her first volunteers in Northern California.
About 1,400 participants at four Kaiser locations will receive the vaccine developed by Pfizer Inc. and the German technology company BioNTech, which sponsors the trial. The developers plan to enroll 30,000 people on more than 120 sites around the world.
The vaccine uses synthetic genetic material, called messenger RNA or mRNA, to prime the body’s immune system to develop cells and antibodies to attack the virus. It is a new approach to immunization that has not yet been used in approved vaccines.
“In some ways (the trial) it is very similar to the type of vaccine tests we do all the time. What is really not typical is the speed at which all this took place, ”said Dr. Nicola Klein, director of the Kaiser Permanent Vaccine Study Center and lead researcher for the trial in Northern California. “Typically, we will be involved with the manufacturers for years.”
The Kaiser arm of the study will be conducted by the Kaiser Permanent Department of Research in Oakland, the Department of Research & Evaluation in Pasadena and the Center for Health Research in Portland, Ore.
Participants must be adults 18 to 85 who are Kaiser members. They may not be pregnant or planning to become pregnant. Kaiser is primarily looking for volunteers who are more likely to develop COVID-19, including people who are older, have underlying health problems, or work in jobs where they are at greater risk for exposure to the virus.
The trial is a double-blind, placebo-controlled study, which means that half of the participants receive the vaccine and half receive a placebo. Neither participants nor researchers will know who received the vaccine.
The worldwide trial was launched in late July, about the same time as another major trial with a vaccine developed by Moderna. The Moderna vaccine also uses mRNA technology.
Both Pfizer and Moderna have won significant funding from the U.S. Health and Human Services Agency as part of President Trump’s Operation Warp Speed to quickly deliver a safe and effective vaccine. Pfizer was offered up to $ 1.95 billion for manufacturing and distributing about 100 million doses of its vaccine. Modern has raised about $ 955 million.
Three other vaccines, made by Johnson & Johnson, Merck and a team from Oxford University and AstraZeneca, are also on the US shortlist of most viable vaccine candidates and have received significant funding.
Erin Allday is a staff writer for the San Francisco Chronicle. Email: [email protected]
