The interim analysis results of MVC COVID-19
Vaccine phase 3 clinical trial in Paraguay meet the
criteria of superiority
Date of events
2022/02/14
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event:2022/02/14
2.New drug name or code:MVC COVID-19 Vaccine
3.Indication:Prevent COVID-19 infection
4.Planned development stages:
apply Emergency Use Authorization (EUA) in various countries; pursue
relative clinical studies and post-marketing surveillance
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical
trials(include interim analysis):
The interim analysis report of MVC COVID-19 Vaccine phase 3 clinical trial
in Paraguay has been generated. The results shows good safety profile and
immunogenicity. The neutralizing antibody titer is 3.7 times higher than
AZ COVID-19 vaccine which meet the criteria of superiority. The interim
analysis results will be submitted to the regulatory authority in the
target markets.
The phase 3 clinical trial in Paraguay (NCT05011526) was cooperated with
University of Asuncion. The aim of the trial is to demonstrate the
immunogenic superiority of MVC COVID-19 Vaccine to AZ COVID-19 vaccine.
This trial has enrolled 1,128 subjects and 934 subjects have completed two
doses regimen. The interim analysis results are as following:
1. In safety evaluation, the vaccine is safe with high tolerance, and no
vaccine-related serious adverse event notification. In systemic adverse
reactions, the subjects with fever is less than 1% which is comparable
with the phase 2 clinical trial conducted in Taiwan.
2. In immunogenicity evaluation, the results included the IgG ELISA
analysis performed by University of Asuncion, the wild type neutralization
(WTNT) performed by the P3 laboratory of Academia Sinica in Taiwan and IgG
ELISA analysis performed by the central lab in Taiwan. The results show
the data from the three independent laboratories have consistent results.
MVC will summarize those phase 3 interim analysis reports and provide to
the regulatory authority for review.
(2)Once disapproved by competent authority or each of clinical trials
(include interim analysis) results less than statistically
significant sense, the risks & the associated measures the Company
may occur: N/A
(3)After obtaining official approval or the results of statistically
significant sense, the future strategy:
submit the study results to the regulatory authority in the target
markets.
(4)Accumulated investment expenditure incurred:
Based on business strategy considerations, it will not be disclosed for
the time being.
6.Upcoming development plan:
(1)Estimated date of completion:
Continue to conduct the relevant clinical studies to support EUA and drug
permit license.
(2)Estimated responsibilities:
All relevant costs for the registration of new drug application.
7.Market situation:
According to Our World in Data, 62.3% of the world's population has
received at least one dose of COVID-19 vaccine, 54.4% are fully vaccinated
and 15.1% has received the 3rd booster dose. The total number of vaccine
doses administered has exceeded 10.4 billion. Based on the demand for primary
series and 3rd booster dose, WHO estimated that there is still a global
demand of more than 10 billion doses of COVID-19 vaccines. The situation of
global shortage and inequality of COVID-19 vaccines may not be relieved in
the short term.
8.Any other matters that need to be specified:
It is not yet possible to specifically assess whether the results of the
interim analysis report of MVC COVID-19 Vaccine phase 3 clinical trial have
a significant impact on the company's finance and business side . If there
is clearer development, we will announce in accordance with relevant
regulations.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:
