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

TAIPEI,Oct. 15,2021 -- 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 thatgives 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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