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DCGI approves study at CMC Vellore to test efficacy of mixing doses of Covaxin and Covishield vaccines

In the month of July, the Central Drugs Standard Control Organisation (CDSCO), an expert panel of the central drug Authority, recommended granting permission to the institute to conduct clinical trials of mixing the vaccine doses.

On August 10, the Drugs Controller General of India (DCGI) approved a study to determine if the doses of Covaxin and Covidshield vaccines can be mixed to fight against Coronavirus. The study and clinical trials will be conducted at Christian Medical College (CMC), Vellore, Tamil Nadu.

In the month of July, the Central Drugs Standard Control Organisation (CDSCO), an expert panel of the central drug Authority, recommended granting permission to the institute to conduct clinical trials of mixing the vaccine doses. The panel had also recommended granting permission to Bharat Biotech to carry out a study on the inter-changeability of Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154. Notably, Bharat Biotech was asked to remove “inter-changeability” from the study title and resubmit the revised proposal.

The Phase-4 clinical trial of the study would include 300 healthy volunteers for mixing the doses of Covaxin and Covidshield. According to the expert panel, the study aims to determine if a person can take two different vaccine shots, i.e. one of each Covaxin and Covidshied, to complete the vaccination course.

 

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