Paraguay announced the Phase III clinical data of its high-end COVID-19 vaccine, and both high-end and AZ vaccines have reached the “superiority” benchmark. (file photo)
[Reporter Chen Yongji/Taipei Report]The third phase of the clinical trial of a high-end COVID-19 vaccine in Paraguay was completed on February 14 this year following the interim analysis was completed, and the subject tracking period has expired. Yesterday (8/1), the executive team of the University of Asuncion in Paraguay shared the results of the laboratory analysis in the country. Whether it is a seropositive subject who has been infected with the COVID-19 virus or a seronegative subject who has not been infected, The high-end comparison AZ vaccines all met the “superiority” benchmark.
High-end said that this clinical trial included a total of 1,128 subjects in Paraguay, and a total of 925 valid samples were analyzed. (central lab) conducted antibody comparison analysis, and the mid-term unblinding data also showed that the data trends of the three independent laboratories were consistent.
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According to the analysis data of the local laboratory shared by the University of Asuncion in Pakistan on 8/1 as follows:
1. Among seropositive subjects, the seroconversion rate (SCR) of the high-end group was 98.6%, the SCR of the control group AZ was 90.0%, and the neutralizing antibody ratio of the high-end group was 1.7 times that of the AZ group.
2. Among seronegative subjects, the seroconversion rate of the high-end group was 100%, and the SCR of the control group AZ was 94.9%; the neutralizing antibody ratio of the high-end group was 4.8 times that of the AZ group.
In addition, in terms of safety tracking, the adverse reaction return of the high-end group was much lower than that of the AZ group, showing the excellent tolerance and safety of the subunit protein vaccine; in the serological index, no matter whether the patient was infected with the COVID-19 virus In seropositive subjects or uninfected seronegative subjects, high-end comparisons with the AZ vaccine achieved “superiority” results. Subsequent high-end companies will use domestic laboratory data as the main body to complete the writing of the Paraguay Phase III Clinical Trial Report (CSR).
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