“The trials are ongoing, and we expect to submit data by the end of this year,” a company insider said. The trials, including over 600 participants, are being conducted by dividing the volunteers into three groups.
The first group is administered Covaxin as the first dose and intranasal vaccine as the second dose. The second group will get both doses in the form of intranasal vaccine.
The third group will get the intranasal vaccine as the first dose and Covaxin jab as the second dose. The doses are given 28 days apart. The intranasal vaccine can be game changer in the vaccination drive because it offers the convenience of administration.
The drug regulatory authority had in August given its approval to Hyderabad-based Bharat Biotech to conduct phase-2/3 trials on its intranasal vaccine.
The adenoviral intranasal vaccine BBV154 is the first of its kind Covid-19 jab which has been undergoing human trials in India. The phase-1 trial in healthy volunteers of age groups ranging from 18 to 60 years was well tolerated, the ministry of science and technology said in a statement earlier.
It also said the vaccine was found to be safe, immunogenic and well-tolerated in the preclinical toxicity studies and was able to elicit high levels of neutralizing antibodies in animal studies.
The development of Bharat Biotech’s intranasal vaccine has been supported by the department of biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC). The company strategised to fast-track research and development efforts, especially for vaccine development, diagnostics, drug repurposing, therapeutics and testing.
Bharat Biotech’s Covaxin had demonstrated 77.8% efficacy against symptomatic Covid-19 and 93.4% against severe illness during the phase-3 clinical trials.