The Drugs Controller General of India (DCGI) has granted permission to Hyderabad-based biotechnology firm Bharat Biotech, the manufacturer of India's first indigenous Covid-19 vaccine Covaxin, for intranasal booster dose trials, news agency ANI reported. The trials will be done at nine different sites.
Earlier this month, DCGI's Subject Expert Committee (SEC) had granted 'in principle' approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine.
Sources told PTI that the intranasal vaccine will be administered to those who have already taken their two-dose vaccine. An intranasal vaccine as a booster dose if becomes a reality would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
The biotechnology company had in its application to the regulator proposed that its nasal vaccine can be used as a booster dose for those who have already been inoculated with Covaxin or Covishield vaccines against coronavirus. It claimed that the nasal vaccine, BBV154, stimulates immune responses at the site of infection (nose) and is very effective in blocking infection and transmission of the virus.
The interval between the second dose and booster dose will be six months, according to reports, adding that the country could get an intranasal booster vaccine in March, after timely conduction of trials.
Earlier on Thursday, the country's drug regulator had granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions.
READ MORE: Bharat Biotech's nasal Covid booster dose gets DCGI approval for Phase III trial
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