Bharat Biotech gets SEC approval for phase 3 clinical trials of COVID booster intranasal vaccine
Jan 05, 2022
By Shalini Bhardwaj
New Delhi [India], January 5 : The Subject Experts Committee (SEC) of the Drug Controller General of India (DCGI) on Wednesday granted approval to Bharat Biotech for conducting intranasal phase 3 trials and heterologous trials for COVID-19 booster intranasal vaccine for those who have taken both the doses of Covaxin and Covishield.
The SEC has asked the Hyderabad-based vaccine manufacturer to submit its revised protocol for trials.
"After detailed deliberation, the SEC 'in principle' agreed for the conduct of both phase 3 superiority study and phase 3 booster dose study in parallel in the light of the pandemic situation. Accordingly, Bharat Biotech has been asked to submit the protocol(s) as recommended for approval," reads the SEC minutes of the meeting.
The vaccine manufacturer plans to conduct clinical trials on 5,000 healthy individuals, 50 per cent of whom have received Covishield and the other 50 per cent have been inoculated with Covaxin.
The report submitted by Bharat Biotech also recommended inoculating the COVID-19 Booster dose after 6 months of getting both the primary doses.
The company had applied for permission sometime around mid-December to conduct clinical trials for its intranasal booster dose vaccine.
