The first phase III clinical trial of the Coronavirus inactivated vaccine was presented Tuesday. China National Biotec Group (CNBG) Coronavirus inactivated vaccine international clinical trial Phase III was held during a video conference in Beijing and Abu Dhabi.
CNBG and UAE group signed a clinical cooperation agreement.
CNBG is the first company that will conduct clinical trials overseas for the Coronavirus vaccine.
During the conference the UAE Minister of Health & Prevention Abdul Rahman Mohammed Al Owais, presented an approved Phase III Coronavirus inactivated vaccine certificate to Ni Jian, Ni Jian is the Chinese Ambassador in the UAE.
At the same time, Dr. Ali Obaid Al Dhaheri, UAE Ambassador in China, presented an approved Phase III clinical certificate of the Coronavirus inactivated vaccine to the Chair of CNBG Yang Xiaoming.
Experts say that clinical research are usually divided into 3 phases.
Phase I mostly evaluate safety. Phase II it mostly evaluates the safety and immunogenicity of the Vaccine and analyze immunization procedures.
Phase III mostly evaluates the safety and effectiveness of the vaccine on a large population.
The entire clinical research process will be running safety evaluations. When the test are coming back as successful, these vaccines will be safe and effective and can protect vaccinated population from the Coronavirus
Experts said that the domestic epidemic was controlled effectively therefore it did not meet the conditions to proceed to Phase III clinical trials, therefore it was promoted actively overseas cooperation in Phase III clinical trials.
According to the CNBG: This inactivated vaccine has passed Phase I & II clinical trials, it doesn’t show any serious adverse reactions, with all volunteers generating antibodies after 2 doses in 28 days.
According to CNBG a total of 1,120 volunteers were vaccinated during the phase-1 and phase-2 clinical trials, all of whom produced high-tier antibodies. In the age group between 18 and 59, those who got two doses of vaccine based on the 0-and-28-day procedure demonstrated 100 percent antibody positive conversion rate, while those who got two doses based on the 0-and-14-day and 0-and-21-day procedures showed 97.6 percent antibody positive conversion rates
The study is the world’s first clinical trial to acquire safety and effectiveness data of a 2 dose inactivated coronavirus vaccine. CNBG added that the clinical trial has lasted the longest period of time (66days) and got the most comprehensive data, as well as the most satisfying results among all Coronavirus vaccines to this date
CNBG has worked the past 2 months to build the world’s largest, highly-efficient Coronavirus inactivated vaccine production facility, with construction standards and quality levels that will meet the international requirements. According to experts the vaccine could enter the market by end of 2020 or early 2021. The facility is able to produce over 200 million doses of inactivated coronavirus vaccines yearly.