TAIPEI, Oct. 15, 2021 /PRNewswire/ -- 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.
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.
MVC's Forward Looking Statements
This press release contains certain forward-looking statements relating to the business of Medigen Vaccine Biologics Corporation (MVC, TPEx: 65470.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's COVID 19 vaccine candidate, MVC-COV1901, and the ability to manufacture, market, commercialize and achieve market acceptance thereof. These forward-looking statements are based largely on the current expectations of MVC as applicable, as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, such could be affected by, among other things, uncertainties involved in the development and manufacture of MVC's COVID19 vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, changes in global financial markets and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that such forward-looking statements will in fact be realized. MVC and is providing the information in this press release as the date hereof, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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