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Bharat Biotech releases Phase-3 trials data of Covaxin

Bharat Biotech revealed the safety and efficacy analysis data from Phase-3 clinical trials of Covaxin, an indigenous vaccine intended to combat the deadly Covid-19 pandemic, on Saturday.

Bharat Biotech stated that the Indian-made Covaxin achieved overall effectiveness of 77.8% against symptomatic Covid-19 patients, citing pre-print results from the country’s largest efficacy trial.

According to the Hyderabad-based biotech company’s findings from the efficacy analysis, Covaxin also showed 93.4 percent effectiveness against severe symptomatic Covid-19 cases. Furthermore, Covaxin offers 65.2 percent protection against the B.1.617.2 or Delta strain, which was responsible for the country’s second wave of Covid-19.

Bharat Biotech claimed Covaxin demonstrated 63.6 percent safety and effectiveness against asymptomatic Covid-19 patients after the completion of its Phase-3 efficacy trial. Phase 2 vaccination studies are used to determine the vaccine’s safety, whereas Phase 3 trials are used to determine the vaccine’s efficacy and effectiveness.

The pre-print study of the total effectiveness rates of Covaxin after Phase-3 studies are as follows:

Asymptomatic cases: 63% efficacy
Mild, moderate, and severe cases: 78% efficacy
Severe Covid-19 cases: 93% efficacy
Delta variant: 65% efficacy

The Covaxin Phase-3 analysis, published on the medRxiv pre-print server, was carried out across 25 hospitals in India as trial sites.

In the final trials, volunteers received two intramuscular injections of either the Covid-19 vaccine or a placebo over the course of four weeks, utilizing a sponsor-supplied randomization system. According to the report, there were 25,800 participants ranging in age from 18 to 98 years old.

Along with Serum Institute’s Covishield and Russian-made Sputnik V, Bharat Biotech’s Covaxin is one of three vaccines presently being injected to the Indian populace. In January, Covaxin received clearance for emergency usage in the Indian population.


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