Reporter : Qu Jian
Editor : Ma Shuhuai
Publisher : Science & Technology Daily
Translation, editing : Gan Yung Chyan
/ KUCINTA SETIA
The Blind Audit and Phased Blindness Seminar of Phase I/II Clinical Trial of the World's First New Coronavirus Inactivated Vaccine, developed by Sinopharm Wuhan Institute of Biological Products, was held simultaneously in Beijing and Henan on the 16th. The results of the blinding show that the safety after vaccination is good, and there is no serious adverse reaction; after different procedures and different doses of vaccination, the vaccine group vaccinates produced high titers of antibodies. Among them, two doses on the 0/28 day program were neutralized. The antibody positive conversion rate reached 100%.
According to Sinopharm China, the clinical trial of the new inactivated vaccine is a randomized, double-blind, placebo-controlled phase Ⅰ/Ⅱ clinical study. On 12 April, the vaccine obtained the first clinical trial approval in the world, and phase I/II clinical trials were launched simultaneously in Wuzhi County, Henan Province.
Under the leadership of Henan Provincial Center for Disease Control and Prevention, clinical trials were conducted for 66 consecutive days, and the safety and efficacy data of the SARS-Conew crown inactivated vaccine after two injections were obtained. For different ages, different procedures, different doses, and different injection times The research results are presented in a more complete manner. This is also the longest time, the most comprehensive data and the most effective clinical research results of the new crown vaccine to date, which provides scientific and evaluable data for epidemic prevention and emergency use.
Sinopharm China Biotech said that the study was designed to evaluate the new crown inactivated vaccine in healthy subjects aged 18-59 years, according to low, medium and high doses and 0/14 days, 0/21 days and 0/28 days. The safety and immunogenicity of the program after vaccination, focusing on the changes in cellular immunity after vaccination, explored the vaccination vaccination program, immunization dose, safety, immunogenicity and changes in antibody levels in vivo. Up to now, a total of 1120 subjects in Phase I/II clinical studies have completed two injections.
The clinical trial plan has been carefully designed, and the blinding process strictly follows scientific and rigorous results. The results are encouraging. The vaccine was safe and effective. The subjects in the vaccinated group all produced high-titer antibodies. The intermediate dose of the 18-59-year-old group followed the 0/14 day and 0/21 day procedures. %, inoculation with two doses of neutralizing antibody positive conversion rate of 100% according to the 0/28 day program.
In response to recent new cases in Beijing and the discovery of new genotypes of the coronavirus through whole-genome sequencing, some experts worry that they may "will lead to weakened or even ineffective vaccines."
Yang Xiaoming, Chief Scientist of the National 863 Program vaccine project and Chairman of Sinopharm China Biotech, was interviewed by a reporter from Science & Technology Daily. He said that he has noticed this new genotype, but it is "still within the coverage of today's phased blinding vaccine", so it will not affect the effectiveness of the current inactivated vaccine.
Sinopharm also disclosed that it is actively advancing overseas cooperation in Phase III clinical research, and has determined cooperation intentions with companies and institutions in multiple countries. Sinopharm China Biosciences has taken the lead in building a high biosafety grade production workshop, which is currently the only SARS-CoV-2 vaccine production workshop in the world that meets biosafety and GMP standards and can meet the needs of emergency vaccination in number.
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