Written byShubham Sharma
The shot, the company says, has been able to generate a strong immune response against the novel coronavirus in a live viral challenge model involving primates.
Here's all you need to know about it.
As part of this pre-clinical trial, Bharat Biotech said 20 rhesus macaques were inoculated with COVAXIN on a two-dose regimen.
They were split into four separate groups - one administered with a placebo of phosphate buffer saline, while the other three were given different levels of COVAXIN combined with adjuvants.
The shots were administered at a gap of 14 days.
Two weeks after giving the second dose, the primates were exposed to a live SARS-CoV-2 virus.
Following the challenge, their blood, nasal swab, throat swab, and other samples were collected, along with chest X-rays, to see how the shot had performed against the deadly respiratory virus.
The primates were also monitored for adverse side effects of the vaccine.
The data from all the samples confirmed the protective efficacy of COVAXIN, with increasing SARS-CoV-2 specific IgG and neutralizing antibodies and reducing replication of the novel coronavirus in the nasal cavity, throat, and lung tissues of the animals.
More importantly, there was also no sign of pneumonia in the group of primates that were vaccinated with the Bharat Biotech vaccine.
Along with being effective, the vaccine was also confirmed to be safe, as the researchers did not witness any adverse effects in the primates.
"To summarize, the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus," the company said in a statement.
Bharat Biotech proudly announces the animal study results of COVAXIN™ - These results demonstrate the protective efficacy in a live viral challenge model.— BharatBiotech (@BharatBiotech) September 11, 2020
Read more about the results here - https://t.co/f81JUSfWpD@icmr_niv #BharatBiotech #COVAXIN #Safety #Vaccine #SARSCoV2 pic.twitter.com/fva1SOcLOr
While these results show that the shot can safely generate an immune response against the novel coronavirus, it is just a part of the study.
To determine the full efficacy and safety of COVAXIN, human trial data is needed, and these 3-phase studies are still going on.
As part of the Phase-1/2 clinical trial of COVAXIN, 1,125 volunteers are being vaccinated.
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