TAIPEI, 2 August 2022
MVC completed the interim analysis of phase III clinical trial of MVC COVID-19 vaccine in Paraguay on February 14, 2022. After the analysis, the follow-up of subjects has also been completed. Yesterday (8/1), the research team from the National University of Asunción (UNA) shared the analysis results from the local laboratory. For both seropositive subjects infected with SARS-CoV-2 and uninfected seronegative subjects, MVC COVID-19 Vaccine is superior to AZD1222.
A total of 1,128 subjects were enrolled in this clinical trial in Paraguay, and 925 subjects were analyzed. The blood samples are 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 interim analysis data also showed that the data trends of the three independent laboratories were consistent.
On August 1, the UNA shared the analysis data of the local laboratory as follows:
1. Seropositive participants neutralizing antibodies: the seroconversion rate of 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.
2. Seronegative participants 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.
In terms of safety follow-up, the adverse reaction reports of the MVC group were much fewer than that of the AZD1222 group, showing the excellent tolerance and safety of the subunit protein vaccine. On the serological analysis, no matter whether seropositive subjects had been infected with SARS-CoV-2 or uninfected seronegative subjects, MVC is superior to AZD1222. Subsequently, MVC will use domestic laboratory data as the main body to complete the Paraguay Phase III Clinical Study Report (CSR) writing.