New Delhi | Jagran News Desk: The All India Institute Of Medical Sciences (AIIMS) will soon be starting the phase 2/3 trials of Hyderabad-based COVID-19 vaccine manufacturer Bharat Biotech's nasal vaccine, news agency ANI reported on Wednesday. The clinical trials will also start at the Institute of Liver & Biliary Sciences and Gurunanak Hospital and INCLEN in Haryana’s Palwal.
Bharat Biotech's intranasal vaccine received regulatory approval for second Phase trials in August, amid ongoing research in many countries to develop nasal spray to help prevent COVID -19.
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.
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.
Bharat Biotech's nasal vaccine clinical trial's principal investigator will be Dr Sanjay Rai. 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.
The adenoviral intranasal vaccine BBV154 is the first of its kind Covid-19 vaccine to undergo human trials in India. According to experts, a significant advantage of nasal vaccines is that they generate a strong immune response at the site of virus entry, which is, the nose. The virus can be stopped from entering the lungs and prevent damage. The vaccine is non-invasive and needle-free.
Meanwhile, AIIMS Delhi has also done clinical trials of Covaxin in the age group of 2 to 18 years.
BBV154 is a chimpanzee adenovirus vectored vaccine candidate that is being developed by the Hyderabad-based vaccine maker in collaboration with the University of Washington School of Medicine at St Louis.
(With inputs from ANI)
Posted By: Sugandha Jha