The Recombinant Adenovirus Type-5 Vectored COVID-19 was developed by Beijing Institute of Biotechnology (Beijing, China) and CanSino Biologics (Tianjin, China). The CanSino Biologics Ad5- nCoV vaccine candidate is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.
Name of the vaccine product is Convidecia™. The route of administration would be in IM injection. The dosage regime is for single dose only (0.5mL per dose). The vaccine consists of target 5 ×1010 viral particles in each dose. Besides, the vaccine does not contain preservatives or adjuvant.
The primary target population of this vaccine is the adults aged 18 and above. The vaccine can be stored and transported at temperatures of 2-8 °C,and production does not require biosafety level three laboratories, which is the case with inactivated vaccines, hence it is more accessible for developing countries with limited facilities. The shelf life of Convidecia™ is 24 months at 2-8 °C. The vaccine remains stable for 60 days at normal room temperature.
Solution Group Berhad through its subsidiary, Solution Biologics Sdn. Bhd. and CanSinoBIO have mutual interest in Collaboration on the potential COVID-19 vaccine co-developed by CanSinoBIO ("Projects") and the Beijing Institute of Biotechnology, Academy of Military Medical Sciences (BIB).
Further the relationship by discussing projects of mutual interest, a larger agreement for development, manufacturing and commercialization was signed between both parties on the 23rd September 2020. Each party would contribute to these projects through scientific and product manufacturing, and that bulk manufacturing would be undertaken by CanSinoBIO and the Fill and Finish Manufacturing by Solution Biologics Sdn. Bhd.
It uses a weakened common cold virus, adenovirus to deliver genetic material (non-replicative) that codes for the SARS-CoV-2 spike protein to the cells. These cells then produce the spike protein and travel to the lymph nodes where the immune system creates antibodies that will recognize that spike protein and fight off the coronavirus.
Unlike inactivated vaccines, CanSino's vaccine is effective with a single dose and can bring dual protection, activating both humoral and cellular immunity simultaneously.
CanSino's global multi-centre clinical trials in countries like Russia, Mexico, Pakistan, Argentina and Chile used uniform standards and organisational plans which involves 40,000 participants in total. Each centre had a principal investigator and a contract research organization as partners. CanSino's vaccine showed 90.98% efficacy rate in preventing severe disease and is effective to prevent 65.7% of symptomatic diseases. Nonetheless, the interim analysis in Pakistan alone showed 100% efficacy at preventing severe disease and 74.8% for symptomatic diseases.
Moreover, CanSino's vaccine has the perfect safety profile as there were no severe adverse events reported in trials across the world. Ad5-nCoV's Phase II and III trials involved aged participants and saw no serious adverse reactions, demonstrating that it is safe for the elderly.
Experts said the efficacy rate is "good" as a single dose vaccine. "Normally speaking, it is difficult for a dose to achieve high antibody levels without the second dose to enhance the immunology," a Beijing-based immunological professor who asked not to be named told the Global Times.
"A 70 percent effective single-dose vaccine may be more valuable than a two-dose regimen with 90 percent efficacy," the WHO Ad-hoc Expert Group previously said in the New England Journal of Medicine. Under the same efficacy rate and capacity conditions, the single-shot vaccine doubles the amount of people being immunized.
"The single dose can vaccinate as many people as possible in the short term compared to traditional two-dose inactivated vaccines. Moreover, it relieves the pressure on production capacity and reduces the cost of administration and transportation.
CanSinoBIO obtained the Emergency Use Approval in Mexico, Indonesia, Pakistan, Chile, Argentina, Ecuador & Hungary and Conditional Marketing Authorization in China & Malaysia of Convidecia™