Bharat Biotech receives DCGI approval for Phase 3 clinical trials of its Intra-Nasal vaccine, Health News, ET HealthWorld

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Bharat Biotech receives DCGI approval for Phase 3 clinical trials of its Intra-Nasal vaccineBharat Biotech on Friday received approval from Drugs Controller General of India (DCGI) to conduct phase 3 clinical trials for its BBV 154 Nasal COVID vaccine. The trials will evaluate the efficacy of nasal vaccine for those vaccinated with the primary two doses of COVID vaccines (Covishield and Covaxin).

Intra nasal vaccines are easier to administer in mass immunization campaigns and can also help in stopping the transmission of the virus. The trials for 0.5 ml single dose of nasal vaccine will be conducted at nine locations in the country.

Hyderabad-based Bharat Biotech had asked for DCGI’s approval last month to conduct Phase-3 clinical trials for its nasal vaccine. The Vaccine maker had highlighted that the vaccine in addition to offering high efficacy will also be easy to administer and can solve the problem of manpower shortage.

Regulator’s approval comes after the Subject Expert Committee (SEC) had recommended granting permission to conduct clinical trials of intranasal vaccines earlier.

Bharat Biotech’s Covaxin along with Serum Institute of India’s Covishield are the two major vaccines administered in India’s vaccination drive against COVID. The two vaccines recently received market approval from the regulator in response to the applications submitted by the vaccine makers.

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