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

Medigen Vaccine Biologics Corporation

2021/10/17 10:41

PR92354

 

TAIPEI,Oct.15,2021/PRNewswire=KYODO JBN/--

 

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

 

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