Faced with criticism of getting a “premature” approval for its Covid-19 vaccine, Bharat Biotech founder Krishna Ella defended the company’s vaccine and had strong words for those questioning its safety and efficacy.

The emergency authorisation to use Covaxin (Bharat Biotech’s vaccine) was in line with the prevailing drug regulatory framework, an emotional and combative Ella, Bharat Biotech’s Chairman and Managing Director, told the media after a controversy erupted following the Drugs Controller General of India’s “restricted emergency use” approval given to the company and Serum Institute of India on Sunday.

Public health voices and politicians have raised concerns on approvals being given, even as the company is yet to complete phase-III trials.

“The 2019 Gazette notifications allows us to get an emergency licence,” Ella said, on proven phase-II trials. The company used a proven safety platform, he said, adding that phase-II data should be out next month, while phase-III trials were expected to be completed in a week on about 26,000 people. While no efficacy data has been submitted so far, Ella said Covaxin had less than 10 per cent side-effects, which was much lesser than other vaccines. And, the adverse events were duly reported in Covaxin’s case, he said, alleging that in the case of the AstraZeneca vaccine, for instance, people were given paracetamol with the vaccine to suppress reactions. “We are 200 per cent safe vaccine,’’ he claimed. (Serum Institute has a production and distribution alliance on the AstraZeneca-OxfordUniversity vaccine, in India and other countries).

Not a ‘back-up’

Ella did not agree with expert explanations that theirs was a “back-up” vaccine, while Serum’s would be deployed first. On the controversial DCGI statement that the vaccine would be rolled out in a “clinical trial mode”, he said, it meant that there would be no placebo (or inert vaccine given to people to help compare with the real vaccine). Covaxin would be given to all and people would be followed up, he said.

“We are 200 per cent honest and transparent,” he said, unhappy with what he called the “bashing” of Indian scientists. “Why (is the) UK vaccine not being questioned,” Ella asked, irked with the “safe as water” comment from the other vaccine camp and referring to AZ-Oxford vaccine’s varying levels on efficacy on different dosages. Was the efficacy 60, 70 or 90 per cent, he asked, pointing to the “serendipity” controversy around the AZ vaccine on dosages oscillating between two, one and a half doses and now two doses including a delayed second dose.

Data to be out soon

Bharat Biotech’s phase-II data will be published shortly, he said, adding that they had as many publications as American company Pfizer, for instance.

On “at risk” production undertaken by Serum and other international companies, Ella said, Bharat Biotech had invested its own funds into the vaccine development and production and not received grants from anyone else. Further, he pointed out that they were the only ones to have a BSL-3 or bio-safety level-3 production facility.

As of now 14 countries, including the US have shown interest in Covaxin and the company is set to take up trials in Bangladesh soon, he said. “We are not just an Indian company, we are truly a global company," he added.

The company plans to start clinical trials on children , he said. The nasal vaccine candidate for Covid-19 being developed by the company will also enter clinical trials soon.

The company aims to make 700 million doses in 2021 in four facilities — three in Hyderabad and one in Bengaluru. They have over 20 million doses already manufactured and another 150 million doses will be ready by July/August.

On Covaxin’s roll out, Ella said: “I would like to roll out right now.'” But a formal purchase agreement with the government is expected. “The government is talking to us,” he said.

No details were given on how the vaccine would be priced, although the expectation is that it would much lower than others in the market.

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