'People criticised us': Bharat Biotech head on Covaxin's journey from March 2020
As Bharat Biotech published the interim efficacy report of the phase 3 clinical trial on indigenous Covaxin, which was found to have 81 per cent efficacy, chairman and managing director Krishna Ella addressed the criticism that the vaccine faced since the trial report was awaited.
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 March 2020, the National Institute of Virology successfully isolated the SARS-CoV-2 virus and the Indian Council of Medical Research (ICMR) entered into a partnership with Bharat Biotech to develop the virus isolate into an effective vaccine candidate.
Bharat Biotech got the strain in May and since then work has been going on. The phase 1 and phase 2 clinical trials conducted in 755 participants demonstrated a high safety profile of the candidate vaccine with seroconversion rates of 98.3 per cent and 81.1 per cent on day 56 and 104, respectively.
The phase 3 trial was started in the middle of November and was conducted on a total of 25,800 individuals across 21 sites. However, the interim result was based on 43 cases, 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.
The vaccine got restricted emergency use approval in January in absence of the phase 3 data. Several ministers, doctors raised questions over administering Covaxin to healthcare workers and frontline workers. Questions were also raised on how in the second phase of vaccination people can be charged for a shot that is still under trial.
Soon after the nod from the Drug Controller General of India, Bharat Biotech and Serum Institute of India issued a joint statement clearing the air that there is no competition over vaccines between the two vaccine-makers.
Out of over 1 crore vaccines administered till last week, only 11 per cent was Covaxin. However, Prime Minister Narendra Modi, Union health minister Dr Harsh Vardhan took Covaxin shots to dispel misconceptions about the vaccine.