Bharat Biotech seeks DCGI's nod to conduct nasal Covid vaccine trials
Jan 8, 2021, 17:25 IST
New Delhi, Jan 8 (IANS) Days after getting Drugs Controller General of India's (DCGI) nod for India's first indigenously-made coronavirus vaccine, Bharat Biotech has again knocked on the doors of the drug controller seeking permission to conduct clinical trials of their intranasal vaccine for the viral disease.
Hyderabad-based Bharat Biotech has applied to the DGCI for permission to start Phase 1 and 2 trials of their nasal coronavirus vaccine, top sources privy to the development told IANS.
Clinical trials of the 'BBV154' - a novel adenovirus vectored, intranasal vaccine for coronavirus -- will be conducted at various locations. The vaccine will be a single-dose one.
The nasal vaccine is different from the two intramuscular vaccines which recently got approval, due to being non-invasive, needle-free, not requiring trained healthcare workers, eliminating needle-associated risks, and suitable for children and adults, having scalable manufacturing.
According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.
The vaccine has demonstrated protective efficacy in mice and hamsters. Mice and hamsters immunised with its single dose conferred superior protection against SARS-CoV-2 challenge, "more so than one or two intramuscular immunisations of the same vaccine and dose".
"Thus, intranasal immunisation of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, thereby protecting against disease, infection and transmission," Bharat Biotech said in a statement.
On January 3, two intramuscular vaccines - Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by Serum Institute of India - were approved for restricted emergency use. Both are two-dose vaccines.
While the full efficacy of Covaxin is yet to be determined, it was given go-ahead by the DCGI citing 'public interest'. Covaxin is an indigenously developed vaccine by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).
(Aakanksha Khajuria can be contacted at aakanksha.k@ians.in)
aka/arm
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Hyderabad-based Bharat Biotech has applied to the DGCI for permission to start Phase 1 and 2 trials of their nasal coronavirus vaccine, top sources privy to the development told IANS.
Clinical trials of the 'BBV154' - a novel adenovirus vectored, intranasal vaccine for coronavirus -- will be conducted at various locations. The vaccine will be a single-dose one.
The nasal vaccine is different from the two intramuscular vaccines which recently got approval, due to being non-invasive, needle-free, not requiring trained healthcare workers, eliminating needle-associated risks, and suitable for children and adults, having scalable manufacturing.
According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.
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"Thus, intranasal immunisation of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, thereby protecting against disease, infection and transmission," Bharat Biotech said in a statement.
On January 3, two intramuscular vaccines - Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by Serum Institute of India - were approved for restricted emergency use. Both are two-dose vaccines.
While the full efficacy of Covaxin is yet to be determined, it was given go-ahead by the DCGI citing 'public interest'. Covaxin is an indigenously developed vaccine by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).
(Aakanksha Khajuria can be contacted at aakanksha.k@ians.in)
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--IANSaka/arm
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