AIIMS to begin Phase 2/3 trials of Bharat Biotech’s nasal Covid-19 vaccine within couple of weeks: Reports

The vaccine, BBV154, is the first intranasal jab in the country to reach late-stage trials.
A health worker collects a nasal sample from a passenger for COVID-19 test, at the Chhatrapati Shivaji Maharaj terminus in Mumbai. (PTI Photo)
A health worker collects a nasal sample from a passenger for COVID-19 test, at the Chhatrapati Shivaji Maharaj terminus in Mumbai. (PTI Photo)
Published on Sep 09, 2021 07:47 AM IST
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By hindustantimes.com, New Delhi

Phase 2/3 trials of Bharat Biotech International Limited’s nasal vaccine against the coronavirus disease (Covid-19) are likely to begin “within a couple of weeks” at the All India Institute of Medical Sciences (AIIMS) in Delhi, according to news agency ANI. The Hyderabad-based company received regulatory approvals to conduct the second and third phase trials of the intranasal vaccine, BBV154, in August.

Also Read | First nasal vaccine developed by Bharat Biotech gets nod for Phase 2/3 trial

For these two stages, mandatory permission from AIIMS Ethics Committee will be required for which an application has already been submitted. Upon receiving the panel’s nod, the exercise will be conducted by administering two doses to volunteers, with a gap of four weeks between the two.

The trials will take place under the leadership of Dr Sanjay Rai. The third phase will commence only after the preceding stage has been fully completed.

It is to be noted that BBV154 is the first of its kind Covid-19 jab to undergo human trials in the country. Phase 1 of the exercise was conducted on health groups volunteers in the age group of 18-60 and was “well tolerated,” the ministry of science and technology had said earlier. The vaccine has been developed with support from the department of biotechnology (DBT) and Biotechnology Industry Research Associate Council (BIRAC).

BBV154 is the first intranasal jab in the country to reach late-stage trials, according to Dr Renu Swarup, secretary, DBT.

Bharat Biotech has also developed India’s first home-made anti-Covid shot, Covaxin, which, along with Covishield, is the most-widely used vaccine in the nationwide inoculation drive, which began on January 16. In its Phase 3 clinical trials, Covaxin demonstrated 77.8% efficacy against symptomatic Covid-19 and 93.4% against severe form of the disease.

 

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Friday, October 22, 2021