TAIPEI (Taiwan News) — Medigen Vaccine Biologics Corp. (MVC), makers of the Medigen COVID vaccine (MVC-COV1901), announced on Thursday (May 13) that Phase 3 clinical trials have entered the data analysis stage.
MVC announced nearly all participants in clinical trials for Medigen, a candidate included in the WHO's Solidarity Trial Vaccines (STV), have completed their two-dose regimen of either placebo or vaccine. The individually randomized, controlled Phase 3 clinical trials include 18,000 subjects in Colombia, Mali, and the Philippines.
The next stage is for independent statisticians to analyze the data and present their findings to a panel of experts in the STV steering committee. Once the analysis of interim data has been completed, the results will be released to the scientific community and the public for review.
Charles Chen, vice chairman & CEO of MVC SAID “It has been an honor to have our vaccine evaluated in the Solidarity Trial Vaccines." Chen thanked participants for providing data on the efficacy of vaccines "during Delta, Omicron and other variants that may arise during the trial."
Provided the results of the trial are good and comply with regulations, Chen pledged the firm will make Medigen available to the public "at the earliest possible opportunity in an equitable and fair manner." Medigen is currently widely available in Taiwan for first, second, and booster shots.
When asked whether the trial includes new variants of the virus such as Delta and Omicron, a representative from MVC told Taiwan News that the study looks into any current variants in circulation during the trial. Therefore, any positive case found in the vaccine or placebo groups will be "recorded and likely sequenced."