Bharath Biotech Gets CDSCO Panel Nod To Manufacture Cholera Vaccine, Inactivated, Oral for 1 year age and above

New Delhi: Noting the outcome of inspections of clinical trial sites conducted by the Central Drug Standard Control Organisation (CDSCO), the Subject Expert Committee (SEC) functional under the CDSCO has granted approval to the vaccine makers Bharat Biotech for manufacturing Cholera vaccine (Inactivated, Oral) for the age group of 1 year and above.

This came after the vaccine maker Bharat Biotech presented the Phase-III clinical trial report, including immunogenicity and safety results as per the approved protocol for granting manufacturing permission for the Cholera vaccine (Inactivated, Oral).

In light of the recommendation of the SEC Vaccine meeting dated 18.07.2023, inspections of clinical trial sites were conducted by CDSCO. The committee noted the outcome of the inspections.

Cholera is an acute diarrhoeal infection caused by ingestion of food or water contaminated with the bacterium Vibrio cholerae. Cholera remains a global threat to public health and an indicator of inequity and lack of social development.

Cholera is an extremely virulent disease transmitted through the ingestion of contaminated food or water. Cholera can cause severe acute watery diarrhea and the severe forms of the disease can kill within hours if left untreated.

At the recent SEC meeting for Vaccine held on 27th March 2024, the expert panel reviewed the Phase III clinical trial report including immunogenicity and safety results of the Cholera vaccine (Inactivated, Oral) presented by Bharat Biotech.

After detailed deliberation, the committee recommended the grant of manufacturing permission for the Cholera vaccine (Inactivated, Oral) for the age group of 1 year and above.

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