Hyderabad, Dec 5 Hours after Haryana Health Minister Anil Vij, who was administered a dose of Covaxin last month, tested positive for Covid-19, the city-based Bharat Biotech said that the efficacy of its Covid-19 vaccine could be determined only fourteen days after a second dose.
"Covaxin has been designed to be efficacious. Covaxin clinical trials are based on a two-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the second dose," said the company in a statement.
"Covaxin is a fully indigenously developed Covid vaccine, with the largest phase three clinical trial conducted in India in 26,000 subjects across 25 sites.
"The goal is to evaluate the efficacy of Covaxin across India," said the statement.
Bharat Biotech said that the phase three trials are double blinded and randomized, where 50 per cent subjects receive vaccine and the balance placebo.
"The phase three trials of Covaxin is the only efficacy trial being conducted in India for Covid vaccines to determine its suitability to the diverse Indian population," the company added.
Bharat Biotech stated it is an innovator, vaccine developer and manufacturer and safety of vaccines is its primary objective, followed by efficacy.
According to the company, it has conducted more than 80 clinical trials in its two-decade history across 18 countries on almost 6 lakh subjects.
"The same reporting procedure is followed for all clinical trials. All clinical trials are conducted in compliance with good clinical practices," the statement highlighted.
It added that the vero cell manufacturing platform used for Covaxin has delivered more than 300 million doses till date with a good safety track record.
( With inputs from IANS )
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