Covaxin efficacy on two-dose schedule: India's Bharat Biotech

Hours after Haryana state's s Health Minister Anil Vij, who was administered a dose of Covaxin last month, tested positive for COVID-19, Indian vaccine manufacturer Bharat Biotech said the efficacy of its COVID-19 vaccine could be determined only 14 days after a second dose

Dec 05, 2020
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Hours after Haryana state's s Health Minister Anil Vij, who was administered a dose of Covaxin last month, tested positive for COVID-19, Indian vaccine manufacturer Bharat Biotech said the efficacy of its COVID-19 vaccine could be determined only 14 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 percent subjects receive the 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 the 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 600,000 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 to date with a good safety track record.

(IANS)

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