The study, which was carried out between Dec 30, 2020, and April 2, 2021, saw 3854 individuals screened and randomly assigned (6:1) to the MVC-COV1901 group, or the placebo group. Eligible participants were healthy adults aged 20 years or older. Participants were administered intramuscularly two doses of either MVC-COV1901 or placebo 28 days apart.
The featured results stated that the seroconversion rate, based on the wild-type SARS-CoV-2 GMT, in the MVC-COV1901 group on day 57 was 99-8%. In both younger and older adults who received the MVC-COV1901 vaccine, almost all participants had seroconversion in younger adults and 99-5% in older adults.
The design of the SARS-CoV-2 antigen used in the MVC-COV1901 vaccine was licensed from the U.S. NIH, which involves a range of molecular modifications to the S-2P pre-fusion spike protein. The combination of CpG 1018 and aluminium hydroxide with this S-2P pre-fusion spike protein shows promising elicitation of both T-cell and B-cell immunity. One of the most distinct findings in the safety profile is the extremely low incidence of fever.
In conclusion, the interim analysis showed that the MVC-COV1901 vaccine has a good safety profile and elicits promising neutralising antibody titres. Compared with other vaccines that have received emergency use authorisation, MVC-COV1901 is safe, well tolerated, and rarely causes febrile reactions in both young and older adults. MVC-COV1901 induces high neutralising antibody and anti-spike IgG titres, and it has a seroconversion rate of almost 100% by day 57. Using WHO IU and BAU conversion models, both methods utilized in the paper provide a predictive efficacy ranging between 80% to 90%.
The results from the study served as the basis for immunobriding that gives the MVC-COV1901 vaccine's Emergency Use Authorization in Taiwan and can support the advancement in subsequent developments.
About Medigen Vaccine Biologics Corp. (MVC)
MVC is a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars. With a goal of national self-sufficiency, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC's pipeline includes enterovirus A71 vaccine, dengue vaccine, influenza quadrivalent vaccine which all have entered late clinical stage. MVC's large-scale production facility is state-of-the-art and adherent to international PIC/s GMP requirements. For more information, visit www.medigenvac.com.
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