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.

Created On: Jul 3, 2021 12:07 IST
Phase 3 trial results
Phase 3 trial results

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.

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.

Background:

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.

Take Weekly Tests on app for exam prep and compete with others. Download Current Affairs and GK app

एग्जाम की तैयारी के लिए ऐप पर वीकली टेस्ट लें और दूसरों के साथ प्रतिस्पर्धा करें। डाउनलोड करें करेंट अफेयर्स ऐप

AndroidIOS

Related Stories

Comment (0)

Post Comment

4 + 8 =
Post
Disclaimer: Comments will be moderated by Jagranjosh editorial team. Comments that are abusive, personal, incendiary or irrelevant will not be published. Please use a genuine email ID and provide your name, to avoid rejection.

    Monthly Current Affairs PDF

    • Current Affairs PDF November 2021
    • Current Affairs PDF October 2021
    • Current Affairs PDF September 2021
    • Current Affairs PDF August 2021
    • Current Affairs PDF July 2021
    • Current Affairs PDF June 2021
    View all

    Monthly Current Affairs Quiz PDF

    • Current Affairs Quiz PDF November 2021
    • Current Affairs Quiz PDF October 2021
    • Current Affairs Quiz PDF September 2021
    • Current Affairs Quiz PDF August 2021
    • Current Affairs Quiz PDF July 2021
    • Current Affairs Quiz PDF June 2021
    View all