Policy & Regulation
Medigen's Phase II MVC-COV1901 vaccine data published in The Lancet Respiratory Medicine
15 October 2021 -

Biopharmaceutical company Medigen Vaccine Biologics Corporation on Friday published data from its MVC-COV1901 vaccine phase 2 clinical trial demonstrating promising immunogenicity and safety profiles at The Lancet Respiratory Medicine, a peer-reviewed medical journal.

Under the study conducted between 30 December 2020 and 2 April 2021, the company screened 3854 individuals 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.

Based on the wild-type SARS-CoV-2 GMT, the seroconversion rate in the company's MVC-COV1901 group on day 57 was 99·8%. Almost all participants had seroconversion in younger adults and 99·5% in older adults.

The interim analysis showed that the company's MVC-COV1901 vaccine has a good safety profile and elicits promising neutralising antibody titres. The vaccine is safe, well tolerated and rarely causes febrile reactions in both young and older adults. It 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, concluded the company.

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