A day after Bharat Biotech announced 81 percent efficacy for Covaxin, a news report stated that India’s first indigenously developed covid-19 vaccine has not yet been reviewed by the Centre.
According to a report by Mint, Covaxin is yet to undergo strict evaluation by the Central Drugs Standard Control Organisation (CDSCO) to come out of the “clinical trial mode” in India’s mass vaccination programme against coronavirus.
Bharat Biotech, which developed the drug that has shown an efficacy of 81% in the initial phase 3 trial analysis, would submit the clinical trial data to the government in the coming days for review, said a senior official at CDSCO, which is under the Drugs Controller General of India (DCGA).
“Bharat Biotech is expected to submit the clinical trial data in 2-3 days. After the company submits the data, the subject expert committee (SEC) will review and evaluate the data,” the report quoted an official as saying.
After coming under the radar for providing emergency approval to Bharat Biotech’s Covaxin without vaccinating enough participants in its phase 3 trial, top officials in the government, on conditions of anonymity, had told News18 on Thursday that the decision was backed by a ‘sound scientific process and logic’.
“The 81 per cent efficacy data of Covaxin is a big validation for India’a scientific community and the stringency of our processes. It shows how the decision to grant emergency use authorisation to Covaxin was backed by sound scientific process and logic,” said a source in the government.
On January 3, the Drugs Controller General of India (DCGI) had approved Covaxin for ‘emergency use’ under ‘clinical trial mode’. The approval was criticised for not having enough data.
Data from 25,800 participants received a vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated. The first interim analysis is based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus 7 cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 percent.