India: DCGI approval for trialling of nasal COVID-19 vaccine

pharmafile | January 28, 2022 | News story | Medical Communications  

The Drugs Controller General of India (DCGI) has given permission to Bharat Biotech to conduct clinical trials for the use of its intranasal COVID-19 vaccine as a booster dose. The Hyderabad-based firm had earlier proposed the booster dose for those who had already been vaccinated with Covishield and Covaxin vaccines.

The news comes three weeks after the Subject Expert Committee of the Central Drugs Standard Control Organisation approved Bharat Biotech’s application. There will be a gap of around six months between the second dose and the intranasal booster. The company has shared that the nasal vaccine, BBV154, stimulates immune responses at the site of infection, namely the nose, and is very effective in blocking infection and transmission of COVID-19.

According to sources, the trials will take place at nine different sites across the country. A total of 400 and 650 individuals participated in the Phase I and Phase II trials held for the vaccine, last year.

It is believed that an intranasal vaccine as a booster may be easier to administer in mass vaccination drives. BBV154 stimulates a broad immune response neutralising IgG, mucosal IgA, and T-cell responses. It is effective for blocking both infection and transmission of the coronavirus, and as it is non-invasive and needle free, trained healthcare workers may not be required to administer it.

Earlier, the DGCI had granted an “in principle” approval to Bharat Biotech to conduct a “Phase III superiority study and Phase III booster dose study” for its intranasal vaccine.

Ana Ovey

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