Bharat Biotech on Saturday announced that Covaxin has been found to be 77.8 per cent effective against symptomatic Covid-19. (Photo: File)
Bharat Biotech concluded the final analysis of its Covid-19 vaccine Covaxin and announced the safety and efficacy analysis data from Phase 3 clinical trials on Saturday. As per this, Covaxin has been found to be 77.8 per cent effective against symptomatic Covid-19.
The indigenously developed vaccine demonstrated 93.4 per cent efficacy against severe symptomatic Covid-19 and 63.6 per cent efficacy against SARS-CoV-2 B.1.617.2, known as the Delta variant.
Covaxin demonstrated 63.6 per cent efficacy against the Delta variant in Phase 3 clinical trials
Against asymptomatic Covid-19, Covaxin was found to offer 63.6 per cent protection, as per the efficacy data.
The safety analysis demonstrated that adverse events reported post vaccination were similar for Covaxin and the placebo. Twelve per cent of subjects experienced commonly known side effects and less than 0.5 per cent subjects felt serious adverse events.
PHASE 3 CLINICAL TRIALS
Phase 3 clinical trials of Covaxin were 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.
According to Bharat Biotech, Covaxin is the first licensed Covid-19 vaccine to report promising efficacy against asymptomatic infections based on qPCR testing. This will help in reducing disease transmission, the company said.
GLOBAL ARENA
In response to the fresh efficacy data, Director General of the Indian Council of Medical Research Dr Balram Bhargava said that Covaxin will "immensely contribute to protect the global community against the deadly SARS-CoV-2 virus" apart from benefiting Indian citizens.
“I am delighted to note that Covaxin, developed by ICMR and Bharat Biotech under an effective public-private partnership, has demonstrated an overall efficacy of 77.8 per cent in India’s largest Covid Phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of the highest international standards. The successful development of Covaxin has consolidated the position of Indian academia and industry in the global arena," Dr Bhargava said.
WHAT NEXT
Bharat Biotech is conducting clinical trials to establish the safety and efficacy of Covaxin in children between the age of 2 and 18 years. A clinical trial to determine the safety and immunogenicity of a booster dose is also underway.
Several research activities are being carried out to study variants of concern and to assess their suitability for follow-up booster doses, the company said.
In terms of production, Covaxin is being manufactured by Bharat Biotech at four facilities in India. The company aims to reach an annualised capacity of 1 billion doses by the end of this year.
Globally, Covaxin has already received emergency use authorisation in 16 countries including Brazil, India, Philippines, Iran and Mexico. The company is in talks with the World Health Organisation to obtain emergency use listing for its vaccine.
Source : https://www.indiatoday.in/coronavirus-outbreak/vaccine-updates/story/bharat-biotech-phase-3-clinical-trial-results-covaxin-efficacy-1823301-2021-07-03
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