Bharat Biotech's COVID-19 vaccine Covaxin's phase 3 trials results have been peer reviewed and published in the medical journal the Lancet.
The vaccine was found to have an efficacy of 77.8 percent against symptomatic infections, as well as provide 65.2 percent protection against the Delta variant.
"Covaxin is the only COVID-19 Vaccine to have demonstrated efficacy data a from phase III clinical trials against the delta variant at 65.2%," reads a statement released by the company.
The findings are in line with the efficacy and safety data announced by the company back in June.
“The peer-review of COVAXIN® phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world leading medical journals."Dr. Krishna Ella, CMD, Bharat Biotech in a press statement
Key Points About the Data
The phase 3 trial was a double-blind placebo test, which means neither the researchers, not the participants knew beforehand who was receiving the placebo and who got the vaccine.
The trial was conducted on 24 419 participants over the age of 18.
It was conducted in 25 hospitals or medical clinics across India.
A total of 130 COVID cases were confirmed, of which 24 patients belonged to the vaccine group and 106 belonged to the placebo leg.
Less than 0.5 percent of the participants experienced adverse side effects after vaccination. No cases of anaphylaxis or deaths were reported.
Other findings of the trials which were shared earlier on, and confirmed in peer review are,
Covaxin was found to be 93.4 percent effective against severe symptomatic COVID-19.
Only 12 percent of the participants experienced common side effects and less than 0.5 percent developed serious adverse events.
It was also found to provide 63.6 percent protection against asymptomatic COVID-19 and 70.8 percent protection against all variants of SARS-CoV-2 virus.
What to Know About Covaxin
Covaxin is a whole inactivate virus type COVID-19 vaccine. This means that the vaccine uses weakened or killed pathogens to trigger an immune response by the body against the real thing.
The vaccine was developed by Bharat Biotech under a partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology.
In January this year, it became the country's first home grown vaccine to receive an EUA (emergency use authorisation) by the Indian drugs regulatory body DCGI (Drugs Control General of India).
Covaxin was, earlier this month, included by the WHO in its list of recognised vaccines, paving the way for easing travel to other countries for recipients of the vaccine, and its supply to other low income countries through COVAX—a global vaccine distribution initiative by the UN and GAVI.
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