BBV154, Bharat Biotech`s intranasal vaccine, gets DCGI`s approval for booster dose trials

The trials of Bharat Biotech`s intranasal vaccine, BBV154, will take place at nine different sites across the country.

New Delhi: India's drug regulator on Friday (January 28) permitted Bharat Biotech to conduct clinical trials of intranasal vaccine BBV154.

Bharat Biotech has received approval for phase 3 clinical trials, which will evaluate the nasal vaccine for both the two dose primary schedule as well as booster dose schedule. During the last meeting, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had recommended the internasal vaccine clinical trials. 

The NOC letter issued by the Drugs Controller General of India (DCGI) read, "Central Licensing Authority hereby permits Bharat Biotech International limited to conduct clinical trials of the new drug or investigational new drug."

"The Phase -3 clinical trial should be conducted as per protocol multi-center study to compare immunogenicity and safety of BBV154 with COVAXIN," the letter added.

The dosage form of the intranasal vaccine is liquid and every single dose contains 0.5ml, the news agency reported. 

The trials of Bharat Biotech's intranasal vaccine, BBV154, will take place at nine different sites including 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.

Intranasal vaccines can be administered easily in mass vaccination campaigns. 

Meanwhile, a day earlier, DCGI had granted conditional market approval to Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin for use in the adult population subject to certain conditions. 

(With agency inputs)