Bharat Biotech's nasal Booster dose trials get approval
An intranasal vaccine as a booster will be easier to administer in mass vaccination drives
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Vaccine manufacturer Bharat Biotech has received approval to conduct the Phase-III clinical trials of an intranasal booster dose on people who have received both doses of Covaxin. Drug Controller General of India (DCGI) today gave the go-ahead for Phase-III trials. The trials will be conducted at 9 locations in the country.
For emergency use, safety data has to be given the DCGI, within 15 days but for market approval the data has to be given to the regulator within 6 months.
Covaxin maker Bharat Biotech and Covishield maker Serum Institute of India, or SII, had given data of ongoing clinical trials to the regulator, which approved the market sale after a subject expert committee on COVID-19 on January 19 recommended approval
An intranasal vaccine as a booster will be easier to administer in mass vaccination drives. Bharat Biotech has said that the nasal vaccine, BBV154, stimulates immune responses at the site of infection -- the nose -- and is very effective in blocking infection and transmission of Covid-19.
It has also underlined how easily a nasal vaccine can be administered and the fact that it would not need trained healthcare workers. Last month, the Hyderabad-based vaccine manufacturer had sought the drug regulator's approval to conduct the phase-III trials of the nasal vaccine. Intra-nasal vaccines can help stop viral transmission.
The fresh approval comes soon after Bharat Biotech's Covaxin and Serum Institute of India's Covishield were cleared for sale in the market. But this doesn't mean these vaccines will be available in the market soon. While people would be able to buy them from hospitals and clinics, details about this are still awaited.
For emergency use, safety data has to be given the DCGI, within 15 days but for market approval the data has to be given to the regulator within 6 months.
Covaxin maker Bharat Biotech and Covishield maker Serum Institute of India, or SII, had given data of ongoing clinical trials to the regulator, which approved the market sale after a subject expert committee on COVID-19 on January 19 recommended approval