Bharat Biotech gets DCGI’s nod to conduct intranasal booster dose trials
New Delhi: The Drugs Controller General of India (DCGI) on Friday granted permission to Bharat Biotech to conduct clinical trials of intranasal vaccine BBV154.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had also recommended the internasal vaccine clinical trials during the last meeting.
The NOC letter issued by the DCGI read, “Central Licensing Authority hereby permits Bharat Biotech International limited to conduct clinical trials of the new drug or investigational new drug.”
The dosage form of the vaccine is liquid for the intranasal route of administration and every single dose contains 0.5ml.
The trials of the Intranasal vaccine will take place at nine different sites of the country.
The trials will be conducted at Atman Hospital, Ahmedabad, Gujarat; AIIMS, Delhi and Patna; Oyster and Pearls Hospitals, Pune; Pt.BD Sharma Postgraduate Institute of Medical Sciences at Rohtak, Haryana; Acharya Vinobha Bhave Rural Hospital, Wardha; Jeevan Rekha Hospital, Belagavi; Rana hospital, Gorakhpur; and Prakhar Hospital, Uttar Pradesh.
“The Phase -3 clinical trial should be conducted as per protocol multi-center study to compare immunogenicity and safety of BBV154 with COVAXIN.” read the letter.
