In an effort to combat the potential harmful effects of COVID-19, the Drug Safety and Research Organization (DSRRO) International (formerly the National Institute of Pharmacological Sciences, or NAPT) sent a unit from Guangdong province, where the virus was first detected, to conduct a study of the successful vaccine candidate produced by Chinese and Hong Kong companies. In its first clinical trial, the investigators found a positive safety effect for COVID-19 in four participants enrolled in the study.
The research was conducted at the Xiangya Hospital in Las Vegas prior to clinical trials and investigators found that cohorts of naive, vaccinated mice developed antibodies to the virus and been more vulnerable to experiencing disease progression caused by SARS-CoV-2 (CoV-2) in vaccinated mice. In addition, results from clinical trials/human subjects showed a drastically shortened viral life cycle in vaccinated mice.
“This positive response shows important advancement in the vaccines field. With this study, we demonstrated that different vaccines produced by multiple vaccine candidates seem to show unique protection from SARS-CoV-2,” said DSHO Director-Medical Officer Diana Yamamoto who conducted the research. She has a long-standing goal of developing China’s first vaccines against the novel coronavirus.
“The complete immune response in unvaccinated mice is highly promising. This is true sub-Saharan Africa, where childhood immunization rates are low and where SARS-CoV-2 is spread,” said DSHO Head of Clinical Research Xin-Sheng Yu, who was part of the Wuqing Ice and Vaccines Program at Xiangya Hospital and was involved in the research. (nVS)Replacing conventional vaccines against COVID-19 will be administered to as many as 15,000 people in Africa. SARS-CoV-2 is believed to be spread most often through contaminated wildlife, with cases in dozens of African nations.
Chinese companies responsible for producing the vaccine candidates say their candidates and their biomarkers are safe and well tolerated in both the healthy and sick population. They said they will make the vaccine candidate available in three to four months, to ensure the time period of the potential efficacy of the vaccine and its effectiveness against infection.
The vaccine candidates all have their share of research in progress and are in various stages of clinical development. The Phase 1 clinical trial will determine safety and immunogenicity of the vaccine candidates in a dose-dense manner. This will be the subject of the second Phase 1 study. These studies will involve testing vaccine candidates in multiple different animal models to optimize the immune response in the animals.
“The more subjects who participate in the Phase 1 trial, the better the safety of the vaccine candidates and it will be a good indicator of the efficacy of the original drugs proven in the Phase 1 study,” said Prof. Ding Ding (Shanghai Medical University)