Calling Bharat Biotech as a company that understands vaccines having produced 16 vaccines and spread across 123 countries, he responded to a wide range of questions from the media. Of these, one was to seek his response to the tweet by Congress MP Shashi Tharoor questioning the manner in which the approval was granted with an apparent “unseemly haste.” Arguing that it was wrong to say the company got a premature approval, he said, “we are eligible and it is not a premature approval.” Quoting the CDSCO (Central Drugs Standard Control Organisation) guidelines and the gazette notification of 2019, he said, “I am eligible after phase II based on five parameters.” The 2019 rules are for emergency situations wherein authorisations could be given to molecules on the basis of phase II data, he said.
But then, to Financial Express Online question on the whether it was right to think that the approval was granted based on phase II data alone, he said, “the approval is not based on phase II data alone . It is based on our extremely good and proven technology platform. Second, it is based on extremely good efficacy data on animals – non human primates (monkeys) and hamsters, third it is based on good data from phase I then on good immunogenicity data (the amount of antibodies the vaccine can produce within the body) from phase II trials. And then, apart from these, based on extremely good neutralization (ability of the antibodies produced by the vaccine in the body to contain the virus) and T-cell response (also the key players in the immune response to a viral infection) in both human and animals. All these parameters mattered and it was based on all these and not just on the phase 2 clinical trials data, he said.
To other question on the amount of stock of vaccines already made and ready, he said, the company has a stockpile of 20 million doses and has plans to ramp up production to 700 million doses from four plants so supply should not be a problem. On whether the government had placed an order for the vaccine doses and if so, how many, he just confined himself to saying “the government is talking to us.”
He also denied as wrong any assumption that the vaccine was being considered as a back up vaccine. To him, this was one more vaccine that was given an emergency use authorisation and that there was no such thing as a back up vaccine.
On the crucial question of what percentage protection the Bharat Biotech vaccine provides and the plans for this in the phase III studies (Pfizer for instance, says its vaccine provides 95 per cent protection to those vaccinated) and when the phase 3 trials will be concluded, Dr Ella said, “in the next two to three days, the first dose injections to the volunteers will be completed.” However, the second dosing of the vaccine had also started, he said. “To almost 6,000 people the second dose has also been administered and this process will be completed in the first week of February. After this, the efficacy (or the protection) of the vaccine will be monitored. As of now, we do not know the efficacy percentage,” he said. However, as per norms, he pointed out, regulators require protection of not less than 50 per cent (that is 50 per cent of the people not getting infected when exposed to the virus after vaccination).” But then, was quick to add: “Please do not quote that I am talking of 50 per cent efficacy but we are confident of much higher levels.”