The Lancet Respiratory
2-1/fulltext), one of the world's best-known peer-reviewed medical journals has
published Medigen Vaccine Biologics(https://www.medigenvac.com/public/en)(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
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.
-1/fulltext) 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
Director, International Business Development
SOURCE Medigen Vaccine Biologics Corporation