India is yet to approve the use of intranasal Covid-19 vaccine, BBV154, developed by the Covaxin maker; trial to be conducted at 5 sites
People without Aadhaar queue up for vaccine, in Howrah. Pic/PTI
India’s drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines. India is yet to approve the use of intranasal Covid-19 vaccine BBV154 developed by the Hyderabad-based company.
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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 the New Drugs & Clinical Trials Rules, 2019. According to official sources, the trial would be conducted at five sites, including AIIMS Delhi.
A health worker with swab samples collected for Covid-19 test, in Gurugram on Friday. Pic/PTI
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. The DCGI on Thursday also gave permission to the firm to conduct phase-3 clinical trial to compare the immunogenecity and safety of BBV-154 (intranasal) with Covaxin. This trial has been permitted to be conducted at 9 sites.
In August, the nasal vaccine had received the regulator’s nod for 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,” a source in Bharat Biotech said.
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, chairman of Bharat Biotech Krishna Ella had said.
Bengal cuts RT-PCR test charge to Rs 500
The West Bengal government has slashed the rate of an RT-PCR test by nearly half to R500 from R950, a senior health official said on Friday. However, the additional charge of Rs 15 per km for home collection of samples remains unaltered, he said, adding that the revised price for Covid test came into effect from January 27.
4,06,22,709
Total no. of Coronavirus cases in India so far
4,92,327
Total no. of deaths due to the virus in India so far
21,05,611
Total no. of active cases in India
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