New Delhi- The Drugs Controller General of India (DCGI) on January 28 granted permission to Bharat Biotech to start conducting booster dose trials for its intranasal coronavirus vaccine.
The approval has been granted to conduct phase-3 trials. The trials would evaluate the nasal vaccine for both the two-dose primary schedule and also to use as booster dose schedule, company sources told PTI.
The trials will be conducted at nine different sites by Bharat Biotech -- the makers of Covaxin.
Earlier this month, in a bid to prevent the spread of coronavirus infection driven by its Omicron variant, India has started administering the precautionary dose of COVID-19 vaccine to healthcare and frontline workers and comorbid people aged 60 years and above.
Bharat Biotech had received regulatory approval for mid-to-late-stage trials for its intranasal vaccine BBV154 in August last year.
The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India in December 2021 stating that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.
The development came a day after the Central Drugs Standard Control Organisation (CDSCO) upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.
Notably, Bharat Biotech chairman Krishna Ella and his co-founder Suchitra Ella will be honoured with the prestigious Padma Bhushan, President Ram Nath Kovind announced on January 25.
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