The company is expected to obtain interim data of its Phase-III clinical trials from across the world this week, the Global Times learned.
The Phase-III clinical trials of Ad5-nCoV saw more than 40,000 volunteers administered with the vaccine in 78 clinical trial sites across five countries in three continents, according to a notice CanSino Biologics sent to the Global Times on Monday.
Distinct from inactivated vaccines, CanSino's vaccine is effective in only one single dose and can bring dual protection.
Ad5-nCoV's Phase-II and Phase-III trials have involved elderly participants, with no serious adverse reactions reported, the Global Times learned on Monday from a source close to CanSino.
The vaccine can be stored and transported at temperatures ranging from 2 to 8 C, and the vaccine production does not need the bio-safety level 3 laboratory as required by the manufacturing of inactivated vaccine, which experts said makes them more accessible to developing countries with limited facilities.
The upcoming interim results were collected from data at multiple centers of Phase-III trials across the world, including Russia, Mexico, Pakistan, Argentina, and Chile. It is a global multi-center clinical trial using uniform standards and organizational plans. Each center has a Principal Investigator (PI) and Contract Research Organization (CRO) partner.
CanSino said it has completed case accrual for the interim analysis of the Phase-III clinical trial of Ad5-nCoV, and data from these cases have been submitted to the Independent Data Monitoring Committee (IDMC) for analysis and recommendation.
The Ad5-nCoV vaccine is a recombinant adenovirus vector vaccine jointly developed by CanSino Biologics and researchers from the Institute of Military Medicine under the PLA Academy of Military Sciences led by Chen Wei.
The COVID-19 vaccines developed by Russia's Sputnik V, British-Swedish pharmaceutical AstraZeneca and Johnson & Johnson use a similar approach
https://www.globaltimes.cn/page/202102/1215023.shtml
