Statement
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1.Date of occurrence of the event:2022/05/13
2.Company name:MEDIGEN VACCINE BIOLOGICS CORPORATION
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):head office
4.Reciprocal shareholding ratios:non applicable
5.Cause of occurrence:
MVC COVID-19 Vaccine is a vaccine candidates included in WHO's Solidarity
Trial Vaccines (STV), a multi center, multi vaccine, adaptive, shared
placebo, event driven, individually randomized controlled Phase 3 clinical
trial. Recruitment for STV for the purposes of MVC COVID-19 Vaccine has
been completed across three countries, Colombia, Mali and the Philippines.
To date, approximately 18,000 participants have been enrolled for the
evaluation of MVC COVID-19 Vaccine. Nearly all participants have completed
their two dose regimen of either placebo or vaccine.
Once participants have completed their two dose regimen, the data will be
analyzed by two independent statisticians. Once the statisticians have
provided their analysis, this clinical data will be further evaluated by a
panel of experts in the STV steering committee. Upon completion of analysis
of the interim data, the results will be published for the review by the
scientific community and public at large. The announcement of the
publication will be provided by WHO.
6.Countermeasures:None
7.Any other matters that need to be specified:
The update of the solidarity trial is due to the WHO mentioned the progress
of the trial in the meeting when the company participated in the meeting.
After the meeting, with the consent of the WHO, the company announced it by
a press release. If there is any update in the future, except to the
announcement in MOPS, others will be made on the company's official website.
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