By Shalini Bhardwaj
New Delhi [India], September 8 (ANI): The All India Institute Of Medical Sciences (AIIMS) here will be starting Phase 2/3 trials of Hyderabad-based COVID-19 vaccine manufacturer Bharat Biotech‘s nasal vaccine soon, sources informed on Wednesday.
Amid ongoing research in many countries to develop nasal spray to help prevent COVID -19, Bharat Biotech‘s intranasal vaccine received regulatory approval for second Phase trials in August.
Sources told ANI that the country’s premier hospital and research centre will be starting trials within a couple of weeks and an application has been put to seek the mandatory permission of the AIIMS Ethics Committee.
Bharat Biotech‘s nasal vaccine clinical trial’s principal investigator will be Dr Sanjay Rai.
After getting the ethics committee’s nod, the second phase of the trials will be conducted on volunteers who will be administered the two doses of the vaccine with a gap of four weeks in between.
The adenoviral intranasal vaccine BBV154 is the first of its kind Covid-19 vaccine to undergo human trials in India.
According to the ministry of science and technology, the Phase 1 trial in healthy volunteers of age groups ranging from 18-60 years was well tolerated.
Trials for the Phase 3 trial will commence after the completion of Phase-2 clinical trials.
AIIMS Delhi has also done clinical trials of Covaxin in the age group of 2 to 18 years. (ANI)