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DCGI gives permission to Bharat Biotech for intranasal COVID booster dose trial

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India is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154. In August, BBV154 had received regulatory approval for mid- to late-stage trials.

The Drugs Controller General of India (DCGI) on Friday gave permission to Bharat Biotech for intranasal COVID booster dose trials. The trials will be done at nine different sites.
Bharat Biotech had in December said that it has submitted an application to the DGCI to in this regard. "We have submitted phase 3 clinical trial application to DCGI," a Bharat Biotech spokesperson said in a statement, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.
India is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154. In August, BBV154 had received regulatory approval for mid- to late-stage trials. There were reports that the mid-stage trial has been completed.
Krishna Ella, the chairman of Bharat Biotech, had earlier said the company is focusing on the intranasal vaccine as existing vaccines require two-dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add to pollution. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc significantly impacting the overall cost of a vaccination drive, he had said.
Covaxin, the company's COVID-19 vaccine was approved for emergency-use approval in the county, is administered through an injection.
With inputs from agencies