As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon.
The company announced that it commenced the Phase III clinical trial to evaluate the investigational COVID-19 vaccine this week. The 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.
Kaiser Permanente has been providing not-for-profit healthcare plans for Americans across the US for 75 years now. It is also dedicated to fostering innovations in care, clinical research, health education and the support of community health.
The Phase III trial will test the vaccine in 1,400 adults and is part of Pfizer and BioNTech’s large-scale global study that is aiming to enroll up to 30,000 participants across 120 sites around the world.
The candidate vaccine, BNT162b2, was fast-tracked to Phase III trials after showing positive interim safety data in early-stage studies.
Kaiser Permanente’s clinical trial will involve healthy individuals between the ages of 18 and 55, and who are members of its health plans.
The Phase III study is a randomized, double-blind trial in which half of the participants will receive the vaccine and half will receive a placebo. In a press statement, Kaiser Permanente outlined that in this phase of the trial, data will be collected about the safety, immune response and efficacy of the vaccine candidate as required for regulatory review.
“Kaiser Permanente is extremely well-positioned to address this public health emergency,” said Nicola Klein, MD, PhD, director of the Kaiser Permanente Vaccine Study Center and principal investigator for the trial in Northern California in the press release.
Speaking about Kaiser Permanente, Klein said, “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.”
Kaiser Permanente is also involved in the testing of Moderna’s investigational COVID-19 vaccine, which is being co-developed by the National Institute of Allergy and Infectious Diseases (NIAID). The Kaiser Permanente Washington Health Research Institute in Seattle was in fact the first site to enroll participants in the Phase I trial for the vaccine. Kaiser began Phase III trials of the vaccine at the end of July.
Although the anticipation for a COVID-19 vaccine is high, many worry that rushing through clinical trials may compromise the robust clinical testing that is required for any vaccine. Nevertheless, the vaccine push continues, hopefully with due diligence and high vigilance.