Bharat Biotech’s Intranasal booster dose gets DCGI’s approval for phase-3 trials

Bharat Biotech’s Intranasal booster dose gets DCGI’s approval for phase-3 trials


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.

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.

According to official sources, 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.

Separately, 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 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,” 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.

Meanwhile, With 2,51,209 people testing positive for the coronavirus infection in a day, India’s total tally of cases increased to over 4.06 crore, according to the Union Health Ministry data updated on Friday.

The death toll has climbed to 4,92,327 with 627 fatalities reported during the 24-hour period, the data updated at 8 am showed.

The active cases decreased by 96,861 to reach 21,05,611 — 5.18 per cent of the total infections — while the country’s recovery rate stands at 93.60 per cent, the ministry said.

The daily positivity rate was recorded at 15.88 per cent, while the weekly positivity rate was 17.47 per cent, according to the health ministry.

The number of people who have recuperated from the disease surged to 3,80,24,771, while the case fatality rate was recorded at 1.21 per cent, the ministry said

After the Friday update, the total number of infections stands at 4,06,22,709, it said.

Meanwhile, the cumulative number of anti-Covid vaccine doses administered in the country so far has crossed 164.44 crore.

India’s COVID-19 tally had crossed the 20-lakh mark on August 7, 2020, 30 lakh on August 23, 40 lakh on September 5 and 50 lakh on September 16.

It went past 60 lakh on September 28, 70 lakh on October 11, crossed 80 lakh on October 29, 90 lakh on November 20 and surpassed the one-crore mark on December 19.

India crossed the grim milestone of two crore on May 4 and three crore on June 23.


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