Submit Phase III clinical trial report up to 180 days: CDSCO Panel Tells Bharat Biotech on Oral Cholera Vaccine
New Delhi: In response to the proposal presented by the vaccine maker Bharat Biotech to manufacture Cholera Vaccine (Inactivated, Oral), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to submit the complete Phase III clinical trial report up to 180 days as per approved protocol and to inspect the trial site.This...
New Delhi: In response to the proposal presented by the vaccine maker Bharat Biotech to manufacture Cholera Vaccine (Inactivated, Oral), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to submit the complete Phase III clinical trial report up to 180 days as per approved protocol and to inspect the trial site.
This came after vaccine maker Bharat Biotech presented the proposal for a grant of permission to manufacture a Cholera Vaccine (Inactivated, Oral) for sale or for distribution along with the interim report of Phase III clinical trial.
Cholera is an acute diarrhoeal infection caused by ingestion of food or water contaminated with the bacterium Vibrio cholerae.Cholera is an easily treatable disease. The majority of people can be treated successfully through prompt administration of oral rehydration solution (ORS). Currently there are three WHO pre-qualified oral cholera vaccines (OCV): Dukoral, Shanchol, and Euvichol-Plus. All three vaccines require two doses for full protection.
Earlier the Medical Dialogues Team had reported that Bharat Biotech International Limited was conducting a Phase III randomized, modified double-blind, multi-centric, comparative study to assess the non-inferiority of immunogenicity, safety, and lot-to-lot consistency of the single strain oral cholera vaccine Hillchol (BBV131) to the comparator vaccine Shanchol.
Prior to that, Bharat Biotech International Ltd. and Hilleman Laboratories, a global organisation for vaccine research and development, collaborated together to manufacture Hillchol, a new oral cholera vaccine.
At the recent SEC meeting for Vaccine held on 18th July 2023, the expert panel reviewed the proposal presented by the vaccine maker Bharat Biotech for the grant of permission to manufacture Cholera Vaccine (Inactivated, Oral) for sale or for distribution along with an interim report of Phase III clinical trial of the Oral Cholera Vaccine.
After detailed deliberation, the committee recommended submitting a complete Phase III clinical trial report up to 180 days as per the approved protocol for further deliberation.
The committee also recommended for inspection of the clinical trial sites.
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