On September 30, Skidaway Hamiltons, Inc., hosted a talk via Zoom on vaccine testing by B. “Willow” Chanthavong, the Director of Clinical Operations for the Neurology Division of Meridian Clinical Research in Savannah. Ms. Chanthavong is research coordinator for several clinical trials of vaccines for COVID-19 at Meridian’s Savannah test site, including Phase 3 trials for Moderna. Meridian is a nationwide company based in Omaha, Nebraska, with 23 sites around the country. Since 1999, Meridian has done 26 vaccine trials involving over 25,000 patients examining vaccines for flu, ebola, Zika, and C. diff.
All of Meridian’s studies are funded by the pharmaceutical companies who make the vaccines, so Meridian gets no direct government support for vaccine studies. Independent third-party monitors come onsite to examine how Meridian is managing the tests, and Ms. Chanthavong points out that “the FDA is who we ultimately answer to”.
Ms. Chanthavong described the staffing required for vaccine testing…research coordinators, research assistants who manage patients, lab support who store and process samples, data entry personnel, and patient recruiters. The primary focus is on patient safety and quality of the data.
For the COVID-19 vaccine tests, Meridian does both antibody testing to examine the efficacy of the vaccines as well as blood tests to watch for side effects. They also have all patients keep a testing diary and periodically check on the patients to look for symptoms like fever, cough, and especially for COVID-19, loss of the sense of taste or smell.
Asked about the tradeoff between the speed of the COVID-19 vaccine tests versus the long-term safety of the vaccines, Ms. Chanthavong pointed out that vaccine technology for this class of viruses has been previously investigated in response to previous outbreaks such as SARS. As a result, the current testing is not omitting anything that is usually done in vaccine testing. It is virtually impossible to cut corners, and the speed at which things are moving is reflective only of the availability of funding. In her estimation, it will take until the Spring of 2021 for the testing and data analysis to be completed on the COVID-19 vaccines and the patients in the tests will continue to be monitored for 2 or 3 years beyond that.
She also pointed out that Meridian is following all of the ethical rules for testing to avoid putting an undue burden on any particular group. Due to the prevalence of cases and increased risk of mortality in minority populations, Meridian sites are focusing on enrollment of these groups, while providing assurance that there are measures in place to prevent historical abusive practices. This is especially important in the South.. The substantial diversity among Meridian’s staff has helped, as well as community outreach.. The Moderna Phase III trial here has a goal of 500 patients which is evenly distributed in terms of diversity.
Ms. Chanthavong also pointed out that all COVID-19 vaccine testing is currently limited to patients at least 18 years of age, and that the vaccine will not be available to children under that age until later testing examines the effects of the vaccine on children.
