The chairman and managing director Krishna Ella addressed the criticism that the vaccine faced since the trial report was awaited, as Bharat Biotech published their interim efficacy report of phase 3 clinical trial on indigenous Covaxin, and found that they have 81 per cent efficacy.
In a video message issued by the company, he said, “Remembering people criticising us saying our data is not transparent, not in the public domain, I am today proud to say that our data are in the public domain in six publications. If people have got patience, they should read those articles.”
In May the Bharat Biotech got the strain and since then the work has been going on. While phase 1 and phase 2 clinical trails have been conducted in 755 participants who demonstrated a high safety profile of the candidate vaccine with seroconversion rates of 98.3% and 81.1% on day 56 and 104, respectively.
However, in March 2020, the National Institute of Virology successfully isolated the SARS-CoV-2 virus and the Indian Council of Medical Research (ICMR) that entered into a partnership with Bharat Biotech to develop the virus isolate into an effective vaccine candidate.
In the middle of November the phase 3 trail was started and was conducted on a total of 25,800 individuals across 21 sites.
However, the interim result was based on 43 cases, out of which 36 cases were observed in the placebo group and the other seven were observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 per cent.
Several ministers, doctors raised questions over administering Covaxin to healthcare workers and frontline workers and the emergency use approval of the vaccine got restricted in January in the absence of the phase 3 data.
There were questions that were raised on how people can be charged for a shot that is still under trial in the second phase of vaccination.
After the approval from the Drug Controller General of India, Bharat Biotech and Serum Institute of India issued a joint statement clearing the buzz that there is no competition over vaccines between the two vaccine-makers.
However, Prime Minister Narendra Modi, Union health minister Dr Harsh Vardhan took Covaxin shots to dispel misconceptions about the vaccine and over 1 crore vaccines have been already administered till last week, only 11 per cent was Covaxin.
