Krishna Ella, Chairman of Bharat Biotech, the company that has made Covaxin and got approval to market the vaccine in ‘clinical trial mode,’ said 10 million doses of the vaccine were ready and efficacy data, showing the vaccine’s ability to protect against COVID-19, would be available by March.
In his online media conference, a fulminating Ella took exception to his vaccine being considered a “back-up vaccine,” meaning that — as several scientists of the Indian Council of Medical Research (ICMR) said — would be useful against mutant strains of the virus if the other vaccines didn’t work. “I don’t know what is backup vaccine. People should be responsible in giving statements such as these. A vaccine’s job is to protect people and there is no question of a so-called backup.”
The efficacy data, Mr. Ella said, couldn’t be immediately provided as the trial was ongoing in over 20,000 volunteers and the nature of clinical trials didn’t allow such “unblinding.” However what made Covaxin a suitable candidate, Mr. Ella underlined, was “excellent” animal challenge (when vaccinated animals are injected with live virus to check protection) and that it produced a “strong” neutralising antibody response. “Immunogenicity is correlated with efficacy. Yes, I agree, we still have to continue testing it. But for the vaccines against Japanese Encephalitis, rabies or even the seasonal flu the practice always has been to examine immunogenicity data.”
He underlined that the 2019 Clinical Trials rules explicitly mentions that in case of an emergency and the existence of an untested drug or vaccine, Phase-2 data that established the safety of a formulation and its immune response were acceptable. “I’m only reading the law as it exists, so why can’t I benefit out of it? We are in an emergency and lives are at stake.”
Though the Drug Controller General of India has approved Covaxin in a clinical trial mode, meaning that the ongoing phase 3 trial would continue (where some get the vaccine and some don’t) and it would also be simultaneously given to those outside the trial, Mr. Ella said he hadn’t got clarity from the authorities on how this was to proceed.
Mr. Ella also questioned the approval accorded to SII’s Covishield vaccine, which is based on the Oxford AstraZeneca vaccine and almost wholly relied on efficacy data generated in the U.K., though without actually naming the company. “The trials in the U.K. have shown widely varying efficacy. There is no data on its performance in Indians and it’s well known that during the phase-3 trial some batches got only half the dose. Had that happened to me in India, I would have been shut down. An innovative Indian product must be encouraged but I see that some of our own scientists have been bashing me. This isn’t right.”