Today's Information |
Provided by: Medigen Vaccine Biologics Corporation | |||||
SEQ_NO | 1 | Date of announcement | 2022/08/03 | Time of announcement | 14:33:07 |
Subject | Clarification on media reports | ||||
Date of events | 2022/08/03 | To which item it meets | paragraph 53 | ||
Statement | 1.Date of occurrence of the event:2022/08/03 2.Company name: Medigen Vaccine Biologics Corp. 3.Relationship to the Company (please enter "head office" or "subsidiaries"):head office 4.Reciprocal shareholding ratios:N/A 5.Name of the reporting media:Economic Daily News 2022/08/03 C05 6.Content of the report: MVC (6547) announced the phase 3 study data of MVC COVID-19 vaccine in Paraguay yesterday (August, 2). MVC said, the National University of Asuncion(UNA) shared the analysis results from the local laboratory on August 1.In seropositive participants, the MVC group is 98.6% (versus 90.0% in AZD1222), and the MVC's neutralizing antibody GMT is equivalent to 1.7 times more than AZD1222. 7.Cause of occurrence: The company's response to the media reports is explained as follows: In the phase 3 clinical trial of MVC COVID-19 vaccine in Paraguay, it was separately analyzed for the antibody titer comparison by the local lab in Paraguay, and the labs in Taiwan, including Taiwan Academia Sinica's P3 lab and central lab. The research team from the National University of Asuncion (UNA) shared the analysis results from the local laboratory on August 1. MVC will use domestic laboratory data as the main body to complete the Paraguay Phase III Clinical Study Report (CSR) writing subsequently. The data shared by the National University of Asuncion (UNA) team on August 1 separated the subjects to the seropositive group who infected with SARS-CoV-2 and uninfected seronegative groups. The data as follows: (1)Seropositive subjects neutralizing antibodies: the seroconversion rate (SCR, the proportion of subjects who converted antibodies after vaccination) of the MVC group is 98.6% (versus 90.0% in AZD1222). The MVC's neutralizing antibody GMT (GMT ratio, the ratio of the generation of antibodies that can neutralize virus toxicity) is equivalent to 1.7 times more than AZD1222. (2)Seronegative subjects neutralizing antibodies: the seroconversion rate of the MVC group is 100% (versus 94.9% in AZD1222), and the MVC's neutralizing antibody GMT equivalent to 4.8 times more than AZD1222. (3)In terms of safey follow-up, the adverse reaction of the MVC group were much fewer than the AZD1222 group. In safety follow-up, it showed the excellent tolerance and safety. On the serological analysis, no matter whether seropositive subjects had been infected with SARS-CoV-2 or uninfected seronegative subjects, MVC COVID-19 Vaccine is superior to AZD1222. 8.Countermeasures:None 9.Any other matters that need to be specified:None |
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Medigen Vaccine Biologics Corporation published this content on 03 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 August 2022 06:51:05 UTC.