Following the release of Phase III clinical data of two inactivated vaccines of Sinopharm Group, Sinopharm and Coxing Zhongwei, another technical route for the deployment of China’s new crown vaccine is an adenovirus vector jointly developed by the team of Academician Chen Wei of the Academy of Military Sciences and CanSino Bio There is new news from the vaccine. On the 1st, CanSino Bio, which is listed in Hong Kong, issued an announcement saying that its recombinant new coronavirus vaccine (Adenovirus Type 5 vector) (“Ad5-nCoV”) has completed the inoculation of more than 40,000 subjects. Interim analysis showed success The pre-set main safety and effectiveness standards have been met, and no serious adverse events related to the vaccine have occurred, so the Phase III clinical trials can be continued.
Kansino said that the accumulated cases of the interim analysis of the Phase III clinical trial of Ad5-nCoV have been completed, and the relevant data has been submitted to the Independent Data Monitoring Committee (IDMC) for analysis and recommendations. According to the company, it is still blind whether participants in the trial are receiving a vaccine or a placebo. A person familiar with the matter disclosed to the Global Times reporter on the 1st that the mid-term results of this vaccine’s Phase III clinical trial are likely to be announced within this week.
CanSino Bio’s adenovirus vector COVID-19 vaccine launched phase I and phase II clinical trials in Wuhan on March 16 and April 12 last year, respectively. It is the world’s first COVID-19 vaccine to enter the clinical research phase. The clinical trial results initially proved the safety of the vaccine, and the data from the two-phase clinical trials were published in the internationally renowned medical journal “The Lancet”. It is reported that the adenovirus vector vaccine transports the non-reproductive surface protein of the new coronavirus to human cells from a harmless virus and stimulates an immune response. Compared with inactivated vaccines and mRNA vaccines, this vaccine only requires one dose. The above-mentioned insider also stated that the adenovirus vector vaccine can induce significant humoral and cellular immunity, give the vaccinators double protection, and only need to be stored at 2 to 8 degrees Celsius, suitable for distribution and transportation.
The announcement stated that the Phase III clinical trial of Ad5-nCoV has completed vaccination of more than 40,000 subjects in 78 clinical research centers in 5 countries on 3 continents. According to previous reports, the countries where Ad5-nCoV is undergoing Phase III clinical trials include Mexico, Russia, Pakistan, Argentina and Chile.
The Phase III clinical trial of Ad5-nCoV is a global multi-center, randomized, double-blind, placebo-controlled, adaptive trial designed to evaluate the effectiveness, safety and immunogenicity of the vaccine in healthy adults 18 years and older . All subjects received a dose of Ad5-nCoV or placebo on day 0, and followed up to monitor the effectiveness of the candidate vaccine and serious adverse events within 52 weeks. According to the “Global Times” reporter, the volunteers included in the Phase III clinical trial of the vaccine include people over 60 years old, and the vaccine has shown good safety in this population.
At present, the global new crown vaccines developed by the same technological route as CanSino Bio’s new crown vaccine also include AstraZeneca/Oxford new crown vaccine and Johnson & Johnson’s new crown vaccine. On January 29 this year, Johnson & Johnson announced that its Janssen company’s new crown vaccine Ad26.COV2.S Phase III clinical trial research results showed that 28 days after a single dose of the new crown vaccine, the total effective rate against moderate and severe new coronary pneumonia reached 66% , The effective rate of preventing serious diseases in all study areas is 85%. On November 23, 2020, AstraZeneca announced its cooperation with Oxford University for the average effective rate of the new crown vaccine AZD1222 to reach 70%. At present, many countries have begun to vaccinate this vaccine.