According to a meeting held simultaneously in Beijing and Henan the province on Tuesday, the results of the clinical trial showed that the vaccine was safe without any serious adverse reaction, and after the different procedures, and different doses of the vaccine were adopted, participants in the vaccine group all produced high titers of antibodies.
People who have received two doses of vaccine at an interval of 28 days, have seen their neutralizing antibody positive rate conversion to achieve 100%.
According to CLUB’s, the Phase I/II clinical trial randomized, double-blind, placebo-controlled clinical studies. On April 12,the vaccine has obtained the world’s first clinical trial approval, and Phase I/II clinical trials were then launched in Wuzhi county Henan of the province.
Under the direction and guidance of the Henan Centre for Disease Control and Prevention, the clinical trials have been conducted for 66 consecutive days and received data on the safety and efficacy of the COVID-19 inactivated vaccine after administration of two injections. The data presented in the results of research on the different ages, different procedures, at different doses and different injection time in a relatively comprehensive manner. It is also the clinical COVID-19 the search for a vaccine that has the longest duration of time, produces the most comprehensive data and obtains the best research results, and thus to provide scientific and evaluable data for epidemic prevention and control as well as emergency use.
GBSC said that the study was designed to evaluate the safety and immunogenicity of the COVID-19 inactivated vaccine in healthy subjects aged 18 to 59 years for low, medium and high doses, and the injections at intervals of 14, 21 and 28 days.
The study focused on changes of cellular immunity after vaccination and explored the immunization procedures immunization, dosing, safety, immunogenicity, and changes in the levels of antibodies in vivo. Up to now, all the 1,120 subjects who took part in the Phase I/II clinical trials have completed two injections.
For those aged 18 to 59 years of age who received two dose average, injections in 14 days and 21 days of interval procedures, they had a neutralizing antibody positive rate of conversion of 97.6%.
For those who have received two mid-dose injections with an interval of 28 days, the neutralizing antibody positive rate of conversion reaches 100%.
In response to the recent new cases in Beijing and the discovery of a new genotype of the virus by sequencing the entire genome, some experts are concerned that the new genotype, ” the vaccine may weaken or even not work. ”
However, Yang Xiaominchief scientist of the national Program ” 863 “vaccine project and president of the CLUB, told Science and Technology Daily he had noticed the new genotype, but it is” still within the coverage of the vaccine, including the Phase I/II unveiling took place today, ” so that it will not affect the efficacy of the inactivated vaccine.
GBSC also said that it is now actively developing overseas cooperation in the Phase III clinical research and confirmed cooperative intentions with businesses and institutions of different countries. He has completed the construction of a high-biosafety-grade production workshop, which is currently the only COVID-19 vaccine production facility in the world to meet the requirements of the biosafety and GMP standards and is capable of responding to the needs of the widespread use of emergency vaccination.
SOURCE of the Science and Technology Daily
For more information: Yu, Haoyuan, +86-13621282870, [email protected]; Fang Linlin, +86-13911995172, [email protected]