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Contributor: PR Newswire Asia (Hong Kong)
Friday, October 15 2021 - 22:22
AsiaNet
Phase II Data Of Medigen COVID-19 Vaccine, Reviewed And Published In The Lancet Respiratory Medicine
TAIPEI,Oct.15,2021/PRNewswire-AsiaNet/--

The Lancet Respiratory 
Medicine(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)0040
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 
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(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00402
-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 
www.medigenvac.com.

Medigen Contact:

Paul Torkehagen
Director, International Business Development
paul@medigenvac.com

Investor Relations:

ir@medigenvac.com

Media Enquiries:

Michelle Bridget 
Continuum PR 
+6012-697-7356/michelle.bridget@continuumpr.com    

SOURCE Medigen Vaccine Biologics Corporation
Translations

Japanese