The Drugs Controller General of India (DCGI), India’s drug regulator, has given permission to Bharat Biotech to conduct phase-3 trial for its intranasal Covid-19 vaccine as booster dose. The trials will be done on participants who have already been administered with SARS-CoV 2 vaccines.
The trials will be carried out 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 Subject Expert Committee (SEC) of the DCGI earlier this year had granted ‘in principle’ approval to Bharat Biotech to conduct ‘Phase III superiority study and Phase III booster dose study’ for its intranasal COVID-19 vaccine.
In August last year, the nasal vaccine had received the regulator’s nod for conducting phase 2 clinical trials.
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BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.
“An intra-nasal vaccine would not only be simple to administer but also reduce the use of needles and syringes, among others. It would also impact the overall cost of a vaccination drive,” Krishna Ella, chairperson of Bharat Biotech said.
Reports say injecting the vaccines into arm muscles can only protect a person’s lungs from Covid-19, but not his/her nasal passages. Intranasal vaccines may prove to be helpful for the protection of upper respiratory tracts.