China National Medical Products Administration (NMPA) announced on February 25 to grant conditional marketing authorization of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)(the "Ad5-nCoV", trade name: Convidecia™). CanSino Biologics Inc. and Professor Wei Chen, a member of the Chinese Academy of Sciences and research team from the Academy of Military Medical Sciences, co-developed this novel vaccine. It is the first approved COVID-19 vaccine built upon an adenovirus-based viral vector vaccine technology platform in China.
As a leading clinical contract research organization (CRO), Tigermed fully participated and supported multicenter phase III clinical study of Ad5-nCoV vaccine and was responsible for cross-country coordination and operations, including project management, data management, biometrics, pharmacovigilance, third-party audit, etc. This is also the first China-initiated phase III vaccine clinical study covering multiple continents, including Asia, Europe, and Latin America.
The international multicenter phase III clinical study of Ad5-nCoV was conducted in Pakistan, Mexico, Russia, Chile, and Argentina. More than 40,000 subjects were vaccinated and the interim data was analyzed. Data shows that the vaccine candidate has an overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination and 68.83% at preventing all symptomatic COVID-19 disease 14 days after single-dose vaccination. Ad5-nCoV has an efficacy of 90.07% at preventing severe disease 28 days after single-dose vaccination and 95.47% at preventing severe disease 14 days after single-dose vaccination. The data is supportive of the fact that the efficacy of Ad5-nCoV meets the relevant technical standards laid out by the World Health Organization and applicable standards and requirements set out in 'Guiding Principles for Clinical Evaluation of Novel Coronavirus Preventive Vaccines (Trial Implementation)' issued by the NMPA.
To verify the safety and efficacy of this COVID-19 vaccine in clinical trials, Tigermed teamed up with CanSinoBIO since September 2020 to deploy scientists and clinical experts in regions that were gravely affected by the pandemic. Additionally, they worked with local researchers to accelerate the delivery of the international multicenter phase III clinical study of Ad5-nCoV efficiently and compliant with international regulatory standards.
Applying its therapeutic expertise and project experience in vaccine development, Tigermed lead and supported local centers to establish the process to meet the needs of continuous screening and high-volume sample enrollment. One week after landing in Pakistan, the joint team quickly initiated the first site and first enrollment of the trial, completed the start-up of multiple centers within one month, and completed the enrollment of 10,000 subjects ahead of schedule. Meanwhile, Tigermed China teams of Biometrics, Medical Affairs, Pharmacovigilance and many other supporting units collaborated with overseas units night and day to ensure the quality of data and results, laid a solid foundation for completion of this international clinical trial and the launch of the vaccine.
"The results from the international multicenter Phase III clinical trial of Ad5-nCoV demonstrate a profound sense of responsibility and an enduring promise of all the involved vaccine researchers." Said Xiaochun Cao, President of Tigermed. "We pay tribute to all the scientists and volunteers who are participated in the development of the COVID-19 vaccine and congratulate Ad5-nCoV's conditional marketing authorization. We want to express special appreciation to Prof. Wei Chen and CanSinoBIO for giving us the chance to work on this extraordinary project, and more importantly, for their great contribution to human health. Tigermed will continue to dedicate itself to facilitating innovative drug and vaccine development for unmet patient needs and saving lives."
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