Expert panel of India's drug regulator mulling Bharat Biotech's nasal vaccine trial proposal

Expert panel of India's drug regulator mulling Bharat Biotech's nasal vaccine trial proposal
BUSINESSINSIDER
New Delhi, A meeting of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) is currently underway to discuss the permission sought by vaccine developer Bharat Biotech to conduct clinical trials of its intranasal vaccine for the coronavirus.

Days after getting the Drugs Controller General of India's nod for restricted emergency use of India's first indigenously-made coronavirus vaccine, Bharat Biotech had applied to the drug regulator for permission to start Phase 1 and 2 trials of their nasal coronavirus vaccine.

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The nasal vaccine is different from the intramuscular vaccine which recently got approval, as it is non-invasive, needle-free, doesn't require trained healthcare workers, eliminates needle-associated risks, suits children and adults and has scalable manufacturing.

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Clinical trials of Bharat Biotech's 'BBV154' - a novel adenovirus vectored intranasal vaccine for coronavirus -- will be conducted at various locations, a top source privy to the development told IANS. The vaccine will be single-dosed.

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 were conferred superior protection against SARS-CoV-2 challenge, "more so than one or two intramuscular immunisations of the same vaccine and dose".

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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 and have been administered to over three lakh people till now. 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).

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Public health experts believe that intranasal vaccines for coronavirus, administered through the nose rather than muscles, can be a potential gamechanger in India's fight against the coronavirus pandemic.

Last month, Pune-based Serum Insititute of India and Codagenix Inc had announced that they have received regulatory approval in the UK to begin an early-stage trial of their single-dose, intranasal coronavirus vaccine.


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