Bharat Biotech concludes final analysis of Phase 3 clinical trials of COVAXIN, claims 77.8% efficacy
Bharat Biotech's COVAXIN, through an efficacy analysis, demonstrated to be 77.8% effective against the symptomatic COVID-19, through an evaluation of 130 confirmed cases, with 24 being observed in a vaccine group versus 106 in the placebo group.
Bharat Biotech on July 3, 2021, concluded a final analysis for its COVID-19 vaccine COVAXIN from the phase 3 clinical trial and claimed the vaccine to be 77.8 percent effective against the COVID-19.
The Hyderabad-based firm also added that COVAXIN gives 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.
As per the company, the efficacy analysis demonstrates COVAXIN to be 77.8% effective against the symptomatic COVID-19, through an evaluation of 130 confirmed cases, with 24 being observed in a vaccine group versus 106 in the placebo group.
|According to Bharat Biotech, COVAXIN has been evaluated through neutralizing antibody responses against the several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma).|
Efficacy analysis demonstrates COVID-19 Vaccine COVAXIN to be 93.4% effective against the severe symptomatic Coronavirus infection.
COVAXIN Phase 3 clinical trials: Key results
• Safety analysis demonstrates adverse events reported were similar to the placebo, with 12% percent of the subjects experiencing the commonly known side effects and less than 0.5% of subjects feeling serious adverse events.
• Efficacy data of phase 3 trials of COVAXIN has demonstrated 63.6% protection against asymptomatic COVID-19 and 65.2% protection against SARS-CoV-2, B.1.617.2 Delta variant.
• COVAXIN was well tolerated and the Data Safety Monitoring Board did not report any safety concerns related to the vaccine.
• The Company has claimed that the overall rate of adverse events observed in COVAXIN was lower than that seen in other COVID-19 vaccines. Bharat Biotech has also so far not sought indemnity for COVAXIN from the governments.
Efficacy analysis demonstrates Covaxin to be 93.4% effective against severe symptomatic COVID19. Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant: Bharat Biotech— ANI (@ANI) July 3, 2021
Continuous improvement of COVAXIN:
Bharat Biotech also assured that its commitment to the continuous improvement of COVAXIN is underway with additional clinical trials to establish the safety and efficacy in children between 2-18 years of age.
The company added that the 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 the Variants of Concern and to assess their suitability to follow up the booster doses.
Innovation from India to protect global population: Bharat Biotech
The Chairman and the Managing Director of Bharat Biotech, Dr. Krishna Ella while commenting on the recent development stated that the successful safety and efficacy readouts of COVAXIN as a result of conducting the largest ever COVID vaccine trials in India establishes the ability of India and the developing countries to focus towards the innovation and novel product development.
With the latest success, India will now be able to protect the global population.
COVAXIN is a COVID-19 Vaccine which is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
COVAXIN is among the four COVID-19 vaccines that have been given emergency use authorization by the drug regulatory body. The other three vaccines are Covishield, Sputnik V, and Moderna.