Heavy! The world's first phase III clinical data of the new crown inactivated vaccine is officially released
The Global Times reporter learned from Sinopharm Sino Biotech on May 26 that on May 26, the international medical journal "Journal of the American Medical Association" (JAMA) published the "Two Novel Coronavirus Inactivated Vaccines" published by Sinopharm Sino Biotech. Evaluation of the effectiveness of protection against COVID-19 infection in adults. The report summarizes and analyzes the effectiveness and safety of the Beijing Institute of Biological Products (BIBP), Wuhan Institute of Biological Products (WIBP), etc. Phase III of the new crown inactivated vaccines, based on the results of the Phase III clinical trial of the China Biologics New Coronary Inactivated Vaccine Clinical trial results.
This is the world's first officially published Phase III clinical trial results of the new crown vaccine, and this is the first time the results of the Phase III clinical trial of China's new crown vaccine have been published.
The two vaccines WIV04 and HB02 in this clinical study were developed and produced by Wuhan Institute of Biological Products and Beijing Institute of Biological Products. The strains used (WIV04 and HB02) were isolated from two patients in Wuhan Jinyintan Hospital. The virus strain was cultured and propagated in a qualified Vero cell line from WHO, followed by inactivation and purification. All vaccines and placebos are verified by the China Institute for Food and Drug Control. After the blinding, each vaccine is used in a single-dose vial with a unique code and the same appearance.
The results of the study showed that the two new inactivated vaccines of China Biologics can produce high-titer antibodies and form effective protection 14 days after two injections, and the positive conversion rate of neutralizing antibodies in the whole population has reached more than 99%. The protective efficacy of the WIV04 vaccine group was 72.8%, and that of the HB02 vaccine group was 78.1%. The safety is good, and the adverse reactions are mostly pain at the injection site, which is mild, transient and self-limiting.
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