Policy & Regulation
Tigermed Supported and Delivered Clinical Study of CanSino COVID-19 Vaccine as Clinical Contract Research Organization
26 February 2021 - - China National Medical Products Administration has granted conditional marketing authorization of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) (the "Ad5-nCoV," trade name: Convidecia), China-based clinical contract research organization Tigermed said.

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 clinical contract research organization, 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.

Tigermed currently represents a worldwide network of more than 60 subsidiaries and 150 offices and sites, with over 6,400 employees across 38 countries in Asia Pacific, Europe, North and South America and Africa.