Bharat Biotech gets DGCI nod for intranasal Covid booster doses
New Delhi, Jan 28: The Drugs Controller General of India (DCGI) has given its approval to Bharat Biotech for trials of its intranasal Covid booster dose in India. The trials will be done at 9 different sites.
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.
India is yet to approve the use of intranasal COVID-19 vaccine BBV154 developed by the Hyderabad-based company. Drugs Controller General of India (DCGI) on January 27 gave the nod to Bharat Biotech to conduct phase-3 randomised multi-centric clinical study to evaluate immunogenecity and safety of its intranasal vaccine as booster dose on participants who have been previously vaccinated with COVID-19 vaccines approved under new drugs under New Drugs & Clinical Trials Rules, 2019.
Sources told PTI that, the trial would be conducted at five sites, including AIIMS Delhi. In December, Bharat Biotech had sought permission from DCGI to conduct phase-3 study for its intranasal COVID-19 vaccine as a booster dose to participants previously vaccinated with SARS-CoV-2 vaccines.
In August, the nasal vaccine had received the regulator's nod for conducting phase 2 clinical trials. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. "BBV154 (nasal covid vaccine) has received approval for phase-3 clinical trials.
The trials will evaluate BBV154 nasal vaccine for both the two-dose primary schedule and booster dose schedule.
- An intranasal vaccine stimulates a broad immune response - neutralizing IgG, mucosal IgA, and T cell responses.
- Immune responses at the site of infection (in the nasal mucosa) - essential for blocking both infection and transmission of COVID-19.
- The nasal route has excellent potential for vaccination due to the organized immune systems of the nasal mucosa.
- Non-invasive, Needle-free.
- Ease of administration - does not require trained health care workers.
- Elimination of needle-associated risks (injuries and infections).
- High compliance (Ideally suits for children's and adults).
- Scalable manufacturing - able to meet global demand.