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Kaiser Permanente announced Wednesday that it will be part of one of the first large-scale human trials of a potential Coronavirus vaccine. Sites in Oregon and California, including Santa Clara and Sacramento, will be part of the Phase 3 trials of a vaccine series produced by Pfizer Inc. and BioNTech.
Trials started Monday and are set to initially test 1,400 people with an unproven mRNA vaccine. The study, after determining proper dosages in patients, will expand its trial to nearly 30,000 worldwide to test the efficacy of the vaccine. 120 facilities are expected to participate.
Healthy Kaiser Permanente members ages 18 to 85 can volunteer for the trial. However, the trial will not take persons who are immunocompromised, those who are pregnant, or those who are planning on becoming pregnant.
“Kaiser Permanente is extremely well-positioned to address this public health emergency,” said Nicola Klein, MD, Ph.D., director of the Kaiser Permanente Vaccine Study Center and principal investigator for the trial in Northern California. “We have been a leader in vaccine research for more than 30 years and have participated in clinical trials for almost every vaccine that has been licensed in the United States. We know we can meaningfully contribute to helping determine whether this vaccine is effective in preventing COVID-19 disease.”
The clinical trial is being conducted by investigators at the Kaiser Permanente Center for Health Research in Portland, Oregon; the Department of Research & Evaluation in Pasadena, California; and the Division of Research in Oakland, California.
The clinical trials will be randomized and involve a placebo meaning neither the patient nor the clinician will know which volunteer will receive the vaccine. Also known as a double-blind study, this will allow for the removal of bias in the study as clinicians start to analyze the data.
Kaiser facilities in Seattle, Washington participated in another set of vaccine trials co-developed by the National Institute of Allergy and Infectious Diseases and Moderna, Inc. which began it’s phase 3 trials in late July.
The U.S. has already allocated billions of dollars to both Moderna, $955 million, and Pfizer, $1.95 billion, in a race to produce the world’s first viable vaccine. Three others, Johnson & Johnson, Merck, and a medical team from Oxford University, are all also working on potentially viable vaccines. Earlier this week Russia claims to have cracked the code, but this information has not yet been verified and has drawn speculation from the international medical community.