Bharat Biotech has received approval from the Drugs Controller General of India (DCGI) to conduct phase-3 trials for its COVID-19 intra-nasal vaccine (BBV154), sources in the company said on Friday, January 28. The trials would evaluate the nasal vaccine for both the two-dose primary schedule and also to use as booster dose schedule, they said.
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, the sources said.
An intranasal 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, chairman of Bharat Biotech Krishna Ella had previously said.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. Bharat Biotech has in-licensed the technology from Washington University in St Louis, the US.
The company had earlier reported that the doses of the vaccine administered to healthy volunteers in the phase-1 clinical trial were well tolerated with no serious adverse events being reported. Previously, the vaccine was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralising antibodies in animal studies, it added.
The phase 1 clinical trials had commenced in March 2021. The company had received the Drug Controller General of India's nod for conducting phase 2 clinical trials of the nasal vaccine in August 2021.
On January 27, Lav Agarwal, the Joint Secretary in the Health Ministry, said that early indications of COVID-19 cases plateauing have been reported in some places but the trend needs to be observed, whilst noting that 400 districts have logged over 10% positivity rate in the week ending January 26.
Stressing the need to continue with precautions to curb the surge in infections, the Union government noted that Karnataka, Kerala, Tamil Nadu, Gujarat, Andhra Pradesh, Rajasthan were recording a high number of COVID-19 cases and positivity. Simultaneously, a decline in COVID-19 cases and positivity rate have been observed in Maharashtra, Uttar Pradesh, Delhi, Odisha, Haryana and West Bengal, the government stated.