December 3, 2021

Bharat Biotech Head Krishna Ella Says Recruited 8,000 Volunteers Already For Phase 3 Trials – India Biotech Chief Says 8,000 Volunteers Recruitment for Phase III Trial


News Desk, Amar Ujala, New Delhi
Updated Sun, 13 Dec 2020 10:15 AM IST

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Hyderabad-based Bharat Biotech has said that the company has recruited 8000 volunteers for the Phase III trial of the vaccine. Bharat Biotech has sought approval from the drug regulator on the basis of data on the first and second phase of testing last week.

Speaking at the FICCI program, Bharat Biotech International (BBIL) President and Managing Director Krishna Alla said, they have already recruited people for the Phase III clinical trials of the vaccine. Out of 22,000 volunteers, we have already recruited around 8000 volunteers. In the last 15 days we have actively recruited. BBIL ​​commenced testing for Phase III on 17 November.

He said, the company applied for marketing approval based on the test data of the first and second phase. Ella believes that since the data obtained after testing on monkeys has demonstrated the efficacy of the vaccine, and the first and second stage data have shown that the vaccine is safe for the human body. Keeping this in mind, the company has applied for marketing approval. Commenting on the development of the vaccine, Alla said, “Everything is being done keeping in mind the international standards.”

The Chairman of BBIL said, the vaccine is completely safe and the company is 200 percent transparent in case of any serious adverse event. Ella insisted, “We are not inhuman people, we are sensitive about our volunteers, but we cannot disclose their names due to confidentiality.” By transparency, I mean that we report incidents to the Regulatory, Data and Security Monitoring Board and Ethics Committee.

The vaccine is safe, Ella said, built on time tested and proven technology. It can be given to people from six months of age to 60 years of age. However, initially the vaccine in India will be approved for adults over 16 years of age.

Hyderabad-based Bharat Biotech has said that the company has recruited 8000 volunteers for the Phase III trial of the vaccine. Bharat Biotech has sought approval from the drug regulator on the basis of data on the first and second phase of testing last week.

Speaking at the FICCI program, Bharat Biotech International (BBIL) President and Managing Director Krishna Alla said, they have already recruited people for the Phase III clinical trials of the vaccine. Out of 22,000 volunteers, we have already recruited around 8000 volunteers. In the last 15 days we have actively recruited. BBIL ​​commenced testing for Phase III on 17 November.

He said, the company applied for marketing approval based on the test data of the first and second phase. Ella believes that since the data obtained after testing on monkeys has demonstrated the efficacy of the vaccine, and the first and second stage data have shown that the vaccine is safe for the human body. Keeping this in mind, the company has applied for marketing approval. Commenting on the development of the vaccine, Alla said, “Everything is being done keeping in mind the international standards.” The Chairman of BBIL said, the vaccine is completely safe and the company is 200 percent transparent in case of any serious adverse event. Ella insisted, “We are not inhuman people, we are sensitive about our volunteers, but we cannot disclose their names due to confidentiality.” By transparency, I mean that we report incidents to the Regulatory, Data and Security Monitoring Board and Ethics Committee.

The vaccine is safe, Ella said, built on time tested and proven technology. It can be given to people from six months of age to 60 years of age. However, initially the vaccine in India will be approved for adults over 16 years of age.


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