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Phase II Data Of Medigen COVID-19 Vaccine, Reviewed And Published In The Lancet Respiratory Medicine


Monday, October 18, 2021 4:16:00 PM

The Lancet Respiratory Medicine, one of the world's best-known peer-reviewed medical journals has published Medigen Vaccine Biologics (MVC) data from its MVC-COV1901 vaccine phase 2 clinical trial which demonstrates promising immunogenicity and safety profiles. The internationally trusted source of clinical, public and global health knowledge has made available the results from a large-scale, double-blind, randomised, placebo-controlled phase 2 trial done at eleven sites in Taiwan, making MVC visible to a global network of researchers, clinicians, industry leaders and other professionals in the field.

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.

SOURCE: Medigen Vaccine Biologics Corporation