Bharat Biotech may release Covaxin efficacy data in two weeks

Covid-19 vaccine maker Bharat Biotech will be releasing the first set of efficacy data for its vaccine from the ongoing phase-3 trials in two weeks, the company's CMD Krishna Ella said.

"We moved so fast, unfortunately, we missed the efficacy timepoint. Had we done the (phase) 2/3 combined, we would have captured efficacy faster. But anyhow, we should be coming out with efficacy in two weeks with the efficacy point data." Ella said according to a report by Mint. She was speaking during a panel discussion at BioAsia 2021.

Ella also said that Bharat Biotech can modify Covaxin to work on the South African variant of the virus within 15 days of getting it from the ICMR. “We are not going to change our manufacturing process. Everything is exactly the same... Just switch in the strain," she said.

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India's drugs regulator on January 3 granted emergency use approval to Oxford-AstraZeneca's Covishield and to indigenously-developed Covaxin even though enough data on the latter's efficacy and safety were not available.

A CDCSO panel had on January 1 pressed Bharat Biotech to try and expedite the process for interim efficacy analysis of the vaccine for further consideration of restricted emergency use approval. However, just a day later, the panel reversed in its stance, saying the data generated from the vaccine so far demonstrates a strong immune response and in-vitro viral neutralization and that it is safe and effective.

Meanwhile, the vaccine distribution data showed the use of Covaxin was sparse in 17 states and UTs across India, with as many as six provinces not using a single dose of the homegrown vaccine.