Convidecia™ Phase III Results Published in The Lancet

Global Multi-center Study Shows Phase III Efficacy and Safety Profile Global Multi-center Study Shows Phase III Efficacy and Safety Profile CanSinoBIO's Phase III clinical trial is a global multicenter, randomized, double-blind and placebo-controlled study inArgentina,Chile,Mexico,PakistanandRussiaand enrolled 45,000 volunteers globally, representing the same sample size as that of other leading global vaccine manufacturers. The Phase III trial results met all of the...

Global Multi-center Study Shows Phase III Efficacy and Safety Profile

CanSinoBIO's Phase III clinical trial is a global multicenter, randomized, double-blind and placebo-controlled study in Argentina, Chile, Mexico, Pakistan and Russia and enrolled 45,000 volunteers globally, representing the same sample size as that of other leading global vaccine manufacturers.

The Phase III trial results met all of the study's primary efficacy endpoints and indicated an overall efficacy rate of 63.7% (95% CI 52.9-72.1) and an efficacy rate of 96.0% (95% CI 70.5-99.5) against severe disease 14 days after receiving a single dose of Convidecia. The overall efficacy rate 28 days post-vaccination was 57.5% (95% CI 39.7-70.0), with an efficacy rate of 91.7% (95% CI 36.1- 99.0) against severe disease. The results met the efficacy rate requirement of the World Health Organization for COVID-19 vaccines. Additionally, the trial proved the safety of Convidecia for a broad range of age groups above 18, including those over the age of 60.

Recent Booster and Inhaled Vaccine Studies Updates

In addition to significantly shortening the vaccination cycle, Convidecia™ can be stably transported and stored between 2°C and 8°C, making it more accessible to regions with insufficient storage facilities and medical resources, reducing the burden placed on healthcare systems and medical workers, and contributing to building broad immune protection globally by leveraging the advantages of its single-dose regimen.

CanSinoBIO has also seen encouraging data in the trial of a booster dose of Convidecia™ for people inoculated with two doses of inactivated vaccines. Data showed that administering a booster dose of Convidecia™ could result in an approximately 78-fold increase in neutralizing antibody level 14 days post-vaccination[2]. Additionally, administering a homologous booster dose of Convidecia™ six months after the prime immunization could result in a 7-fold increase in neutralizing antibody level.

In addition, CanSinoBIO has made notable progress in the development of its Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for inhalation. Studies showed that a combination of intramuscular and inhaled regimen of Convidecia™ provides stronger protection than a single intramuscular dose. The neutralizing antibody level 28 days after the mixed regimen was four times higher than that of a single intramuscular injection, which could remain at a high level after 6 months.

CanSinoBIO's inhaled version of its COVID-19 vaccine Convidecia™ can be inhaled through the respiratory tract and lungs, thereby stimulating mucosal, humoral and cellular immunity with added layer of protection. CanSinoBIO is committed to continuing to explore the optimal COVID-19 vaccination strategy for the world, making continuous contributions in the global fight against the pandemic.

About CanSinoBIO

Incorporated in 2009, CanSinoBIO (SSE: 688185, HKEX: 06185) commits to research, production and commercialization of innovative vaccines for China and global public health security. It possesses five integrated platform technologies including adenovirus-based vectors, conjugation, protein design and recombination,formulation and mRNA. As of today, it has established a robust pipeline of 17 vaccines preventing 12 diseases, including the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) conditionally approved in 2021 ，and the Group A and Group C Meningococcal Conjugate Vaccine (CRM197) approved in the same year.