No Efficacy Data Yet; Preparing Proposal to Inoculate Children Between 2 & 16 Years: Bharat Biotech Chairman

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As the country readies itself for the long-awaited COVID-19 vaccination drive beginning Saturday, Bharat Biotech Chairman Dr Krishna Ella said India can expect interim efficacy data on its vaccine once the trials are over. He also added that Bharat Biotech is preparing a proposal to start trials in children aged between 2 and 16.

In an interview to CNN-News18's Sneha Mordani, Bharat Biotech Managing Director Dr Krishna Ella and co-founder and Joint Managing Director Suchitra Ella talked of the efficacy data, Covaxin's availability in the market and its effectiveness against the new coronavirus variant.

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On the question of efficacy data, Dr Krishna said, "There is no data on efficacy as yet. I have good Phase I and Phase II data. For efficacy, data on neutralising anti-bodies is important and for that I have enough data and which is soon going to be published."

Further Dr Suchitra said, "The efficacy data and trials are live and they cannot be fast tracked. There is a time-frame and protocols to follow before giving efficacy data. I cannot put a date to it."

On being asked when can children be included in the vaccination drive, the Bharat Biotech chairman said, "Our phase three trial included people aged 12 and above. We are soon going to submit a proposal for those between 2 and 16 years.

Commenting on the short time span in which the company has been able to manufacture vaccines, Krishna said, "This is historical. It was a learning curve for all of us, including the regulatory (body), government, missionaries, everybody. Including NGOs, all the people it was a learning curve. That it can be done. I think the pandemic is just the starting point, there are going to be more pandemics in the future too and I think it is helping us to shape up a lot of things. Build a lot of technological ideas, positioning strategies, manufacturing capabilities and the regulatory system."

"I think this is a learning curve not only for our country but globally. Global health has transformed You look at mRNA vaccine, nobody expected mRNA vaccine to make it in 8-9 months with new technology. It has all happened because of the pandemic," he goes on to say.

Speaking about relief on indemnity front, Dr Suchitra said, "It's not playing a major role in our work. That is for the government agencies to take a call and is beyond our purview."

The Centre has ordered 55 lakh doses of Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The first tranche of 2.4 lakh doses has been dispatched to 12 states, including Ganavaram, Guwahati, Patna, Delhi, Kurukshetra, Bengaluru, Pune, Bhubaneswar, Jaipur, Chennai, Lucknow and Hyderabad.