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Bharat Biotech receives DCGI approval for Phase 3 trials of intranasal COVID vaccine

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eMediNexus    29 January 2022

Bharat Biotech has been granted Drugs Controller General of India (DCGI)’s approval for conducting phase 3 clinical trials for its intranasal COVID-19 vaccine.

The trials will assess the efficacy of the nasal vaccine for people who have received primary two doses of Covishield and Covaxin. The trials for 0.5 ml single dose of nasal vaccine will be carried out at nine locations in India. Bharat Biotech had asked DCGI last month for an approval to conduct phase 3 clinical trials for its nasal vaccine. The company had emphasized that the vaccine, besides offering high efficacy, will be easy to administer and could also solve the issue of shortage of manpower. The Subject Expert Committee (SEC) had also recommended granting permission to conduct clinical trials of the intranasal vaccine… (ET Healthworld, January 28, 2022)

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