On June 16, the blind review of phase I/II clinical trials of the novel coronavirus inactivated vaccine developed by Sinopharm Group's China National Biotec Group (CNBG) Wuhan Institute and the meetings to release the results were held simultaneously in Beijing and Henan.
Relevant experts from the State Council's prevention and control mechanism group and the National Ministry of Science and Technology's biotechnology development center attended.
The results of the blind review show:
1. Good safety after vaccination
2. No serious adverse reaction
3. After different procedures and different doses of vaccination, all vaccinators in the vaccine groups produced high-titer antibodies
4. After 28 days of inoculation with two doses, the positive conversion rate of neutralizing antibody reached 100%
On April 12, the world's first inactivated vaccine for coronavirus was approved for clinical trials, and phase I/II clinical trials were launched simultaneously in Wuzhi County, Henan Province and Beijing City.
After 66 days, the team has obtained the world's first safety and effectiveness data after the inoculation of the coronavirus inactivated vaccine. The research results of different ages, different procedures, different doses, and different injection times are all presented in a relatively complete manner.
They are the most comprehensive data with the longest time, and the most effective clinical research results of the new coronavirus vaccine to date, which provides scientific and evaluable data for the prevention and emergency use in China's epidemic situation.
Up to now, a total of 1,120 subjects in phase I/II clinical studies have completed 2 injections.
The subjects in the vaccinated group all produced high-titer antibodies. The 18-to-59-year-old group received a dose of 97.6% antibody after the two doses were vaccinated in both the 14-day and 21-day procedures. The neutralization antibody positive conversion rate reached 100% in 28-day procedure.
At the same time, CNBG actively promotes overseas cooperation in Phase III clinical trials, and has determined cooperation intentions with companies and institutions in multiple countries.
CNBG has taken the lead in building a high biosafety level production workshop, which is currently the only new crown vaccine production workshop in the world that meets biosafety and GMP standards and can meet the needs of emergency vaccination in number.