NEW DELHI: With India’s apex drug regulator approving Bharat Biotech to start clinical trials of intranasal Covid-19 vaccine candidate, hopes have risen that the country could soon have a crucial and easy tool to prevent the highly infectious disease.
As intranasal vaccine requires minimal training to administer and will not need a needle and syringe, it is being touted as a game changer in controlling the pandemic. A subject expert committee on Covid-19 of the CDSCO earlier this month permitted the Hyderabad-based vaccine maker to launch the Phase I clinical trial of an intranasal vaccine candidate for the Covid-19.
“After detailed deliberation, the committee recommended for the conduct of proposed Phase I clinical trial,” said the minutes of the SEC meeting. The approval followed Bharat Biotech presenting its proposal along with revised Phase I clinical trial protocol of the chimpanzee adenovirus vectored Covid-19 Vaccine intranasal as sought by the committee, at its meeting last month.
Bharat Biotech and Washington University School of Medicine in St Louis had announced a licensing agreement in September for the nasal vaccine candidate, under which the company bagged the distribution rights in all markets except the US, Japan and Europe.
As per the CDSCO approval, the Phase 1 trial will involve testing the vaccine candidate on 75 volunteers in the proposed doses as per the protocol and will help generate safety and immunogenicity data. “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,” VK Paul, member (health), Niti Aayog had said last month.
Many experts feel that nasal spray vaccines, apart from being easy to administer, is far likelier to prevent the virus from gaining a foothold in the body at an earlier stage. “There is so much stress on these vaccines because the evidence so far suggests that they can generate what we call a mucosal immune response,” said a member of the National Covid-19 task force. “In comparison to injectable vaccines, nasal sprays could also be far effective in reducing a person to person transmission of the disease.”