The Drugs Controller General of India (DCGI) granted Bharat Biotech authorization to undertake clinical studies of the intranasal vaccine BBV154 on Friday.
During the previous meeting, the Central Drugs Standard Control Organisation (CDSCO) Subject Expert Committee (SEC) also supported the internasal vaccine clinical studies. "Central Licensing Authority hereby permits Bharat Biotech International Ltd to undertake clinical trials of the new drug or investigational new drug," read the DCGI's NOC letter.
The vaccine comes in a liquid dosage form for intranasal administration, with each dose containing 0.5ml. The Intranasal vaccination will be tested in nine different locations across the country.
Atman Hospital in Ahmedabad, Gujarat; AIIMS in Delhi and Patna; Oyster and Pearls Hospitals in Pune; Pt.BD Sharma Postgraduate Institute of Medical Sciences in Rohtak, Haryana; Acharya Vinobha Bhave Rural Hospital in Wardha; Jeevan Rekha Hospital in Belagavi; Rana Hospital in Gorakhpur; and Prakhar Hospital in Uttar Pradesh will all participate in the trials. "The multi-center Phase -3 clinical trial to compare immunogenicity and safety of BBV154 with COVAXIN should be conducted according to protocol." the letter should be read.