On the 3rd of July, the Hyderabad based Bharat Biotech International Private Limited pharmacy company, concluded the phase 3 clinical trials of COVAXIN. ,
Manufactured by Bharat Biotech, COVAXIN is one of the vaccines being used in India against the deadly Wuhan virus, also known as the Novel Coronavirus (COVID-19.) The final study or clinical treatment was conducted at 25 sites across India. It was an event driven analysis of 130 symptomatic Covid-19 cases, reported at least two weeks after the second dose.
While 24 subjects were observed in the vaccine group, another 106 were administered placebo doses
Though COVAXIN was in use, the final phase (Phase 3) clinical trials of the vaccine was being held, which was completed on the 3rd of July. As per the analysis, the India made COVAXIN is said to be 77.80 % effective against COVID-19. The Bharat Biotech pharma company said, COVAXIN gives 65.2 % protection against the SARS-CoV-2, B.1.617.2 variant also termed as the Delta variant.
The company said, “Efficacy analysis demonstrates COVAXIN to be 77.8 % effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. Efficacy analysis demonstrates COVAXIN to be 93.4 % effective against severe symptomatic COVID-19.
As per the safety analysis, the drug has 12 % side effects and less than 0.5 % serious adverse effects.
Meanwhile, Bharat Biotech also said that it is commitment to continuous improvement of COVAXIN is well underway with additional clinical trials to establish safety and efficacy in children between 2-18 years of age.
“A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow up booster doses.”
