Bharat Biotech's intranasal COVID booster dose gets DGCI nod for phase 3 trials

An intranasal vaccine would not only be simple to administer but also reduce the use of needles, the Covaxin-maker said. 'BBV154' is a replication-deficient adenovirus SARS-CoV-2 vectored vaccine

|Jan 28, 2022, 18:21:31 IST

New Delhi/Hyderabad: 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 27 January gave the nod to Bharat Biotech to conduct phase-3 randomised multi-centric clinical study to evaluate immunogenicity and safety of its intranasal vaccine as booster dose on participants who have been previously vaccinated with COVID-19 vaccines approved 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.Read all the Latest News, Trending News, Cricket News, Bollywood News,India News and Entertainment News here. Follow us on Facebook, Twitter and Instagram.

'From make in India to launch from India': Skyroot COO on why Vikram-1 could change India’s space sector

Skyroot Aerospace’s successful Vikram-1 mission marks a major milestone for India’s private space sector, as the country seeks to shift from “Make in India” to “Launch from India” and compete in the global commercial satellite launch market

8 min read

Choke terror funding, keep international shipping lanes safe: Jaishankar at Asean Regional Forum

Jaishankar's remarks came against the backdrop of recent terror attacks targeting India and growing threats to commercial shipping amid conflicts in West Asia and Europe

2 min read

PM Modi announces fast-track courts for paper leak cases; CJP responds ‘Dharmendra Pradhan must go’

Amid protests demanding accountability for the leak of medical entrance test Neet and other irregularities in the education system, Prime Minister Narendra Modi has announced that the government has decided to set up fast-track courts to ensure swift and stringent punishment for those involved in paper leaks.

3 min read

Sikkim tunnel collapse rescue resumes, death toll rises to 22

The death toll at the collapsed tunnel at Sikkim's Namchi district rose to 22 after nine more bodies were recovered overnight. At least 27 workers were trapped in a tunnel at an NHPC project after a sudden burst of suspected methane gas trapped within rock formations triggered an explosion.

2 min read

Delhi Police asks personnel to wear uniform: What the law says on cops in plainclothes during protests

The Delhi Police has instructed all its personnel to wear uniforms when they report for duty at Jantar Mantar for crowd control. This comes after outrage grew over videos of men in civilian clothes or without name tags hitting protesters in the Capital. Is it legal for the police to ditch uniforms during protests?

4 min read

Up Next