Hyderabad-based Bharat Biotech has submitted the phase 3 clinical trial application to the Drugs Controller General of India (DCGI), seeking a late-stage trial for a booster dose of its first intranasal COVID-19 vaccine that can be given to those who have been administered Covaxin and Covishield vaccines.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. India is yet to give a nod to the use of Bharat Biotech’s intranasal vaccine.
“We have submitted phase 3 clinical trial application to DCGI (Drugs Controller General of India),” a Bharat Biotech spokesperson said in a statement, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.
The Hyderabad-based vaccine maker had received regulatory approvals for conducting the second and third phase trials of the intranasal vaccine in August. The mid-stage trial has reportedly been completed.
Phase 1 clinical trial of the nasal vaccine was completed in age groups ranging from 18 to 60 years.
BBV154 is the first of its kind COVID-19 jab that underwent human clinical trials in India. The vaccine has been developed with support from the department of biotechnology (DBT) and Biotechnology Industry Research Associate Council (BIRAC).
While several states are pressing for the rollout of booster doses of COVID vaccines for adults amid rapid surge in Omricron cases, Union Health Minister Mansukh Mandaviya earlier this month said in Parliament that the government will move forward on the key issue only on the basis of scientific recommendations of its expert groups on vaccine administration.
Bharat Biotech which has in-licensed technology from Washington University in St Louis in the US has also manufactured India’s first indigenously-developed COVID-19 vaccine – Covaxin.
In its phase 3 clinical trials, Covaxin showed the effectiveness of 77.8 per cent against symptomatic COVID-19 and 93.4 per cent against severe form of the disease.
Covaxin and Covishield are the most widely-used vaccines in the countrywide inoculation drive, which began on January 16.
