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On December 24th, CanSino Bio announced that it has published a global multi-center phase 3 clinical trial of the recombinant new coronavirus vaccine (type 5 adenovirus vector) in the international authoritative medical journal "The Lancet" recently.
And mid-term safety analysis results
.
The data shows that it is safe and effective to inoculate a dose of Kvisa in healthy people aged 18 and above
Public information shows that this recombinant new coronavirus (SARS-CoV-2) vaccine was developed by the joint team of CanSino Bio and the Institute of Bioengineering, Academy of Military Medicine, Chinese Academy of Military Sciences.
The vaccine uses replication-deficient adenovirus 5 (Ad5).
) As a vector, it is a recombinant new coronavirus vaccine expressing the new coronavirus spike protein
.
In February 2021, the vaccine has received conditional approval for marketing in China
According to the press release, CanSino Bio has carried out a randomized, double-blind, placebo-controlled global multi-center Phase 3 clinical trial in five major research centers in Argentina, Chile, Mexico, Pakistan, and Russia.
A total of 45,000 people were enrolled in China.
One of the largest clinical trials of the new crown vaccine is currently being carried out, and the proportion of elderly people included is greater than 10%
.
The main efficacy endpoint of the test is to evaluate the protective efficacy of preventing laboratory-confirmed (PCR positive) symptomatic new coronary pneumonia disease at least 28 days after vaccination of 1 dose of Kevisa.
The data shows that 28 days after vaccination with 1 dose of Kevisa (dose 0.
5ml, 5x1010 VP/mL), the overall protection rate was 57.
5%, and the critical protection rate was 91.
7%; 14 days later, the overall protection rate was 63.
7%, and the critical protection rate was 63.
7%.
96.
0%
.
The final analysis results of the global multi-center phase 3 clinical trial reached the protection rate standard recommended by the World Health Organization
The press release also stated that Keweisha adopts a one-dose vaccination program, which can greatly shorten the vaccination cycle, and the vaccine can be stored and transported stably between 2°C and 8°C for a long time, which can greatly reduce the cost of vaccination management
.
The effectiveness and convenience of Keweisha provide convenience for areas with scarce medical resources and greatly reduce the workload of the medical and health system
Previously, the results of a clinical study on the sequential vaccination of the new crown vaccine carried out by the Jiangsu Provincial Center for Disease Control and Prevention showed that after two doses of inactivated vaccine, another dose of Kevisa was used as a booster, and the antibody level increased by about 78 times after 14 days.
.
It is worth mentioning that CanSino Bio's clinical trials of aerosolized inhalation of the new crown vaccine have achieved phased results
.
Clinical data shows that the combined immunization effect of intramuscular injection and inhalation of the adenovirus vector new crown vaccine is better than that of simple intramuscular injection.
Reference materials:
Reference materials:[1] Heavyweight | Global multi-center phase 3 clinical data released for the first domestic adenovirus vector new crown vaccine.
[1] Heavyweight | Global multi-center phase 3 clinical data released for the first domestic adenovirus vector new crown vaccine.
Retrieved Dec 24, 2021, from https://mp.
weixin.
qq.
com/s/0C8zVm2yrPAsQA-QPl3gSw
