Indian Drug Regulator's Expert Panel Recommends Phase 1 Trial Of Bharat Biotech's Intranasal Covid-19 Vaccine

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday (19 January) recommended Bharat Biotech's intranasal vaccine for coronavirus for phase 1 clinical trials. The final call will now be taken by the Drugs Controller General of India.

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 the clinical trials of their nasal coronavirus vaccine.

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.

Earlier on Tuesday, Dr VK Paul, Member, NITI (National Institution for Transforming India) Aayog had said, "A nasal vaccine candidate has been identified. It has come for consideration for phase 1 and phase 2 trials. If it works then it could be a game-changer."

"Phase 1 has been recommended," top government sources told IANS. Clinical trials of Bharat Biotech's 'BBV154' -- a novel adenovirus vectored, and intranasal vaccine for coronavirus -- will be conducted at various locations. 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 immunized with its single-dose conferred superior protection against the SARS-CoV-2 challenge, "more so than one or two intramuscular immunizations of the same vaccine and dose."

"Thus, intranasal immunization 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 3 January, two intramuscular vaccines - Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by the Serum Institute of India were approved for restricted emergency use and have been administered to over four lakh people till now. Both are two-dose vaccines.

While the full efficacy of Covaxin is yet to be determined, it was given the 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).

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

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

(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)