Govt’s expert panel approves study on mixing of vaccine dose
Get authentic, real-time news that helps you fight COVID-19 better.
Install PlexusMD App for doctors. It's free.
An expert panel of India’s central drug authority on July 29 recommended granting permission to the Christian Medical College (CMC) in Vellore for conducting a clinical trial of mixing of two COVID-19 vaccines — Covaxin and Covishield — official sources said.

The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word interchangeability from the study title and submit a revised protocol for approval.

“The SEC (subject expert committee) after detailed deliberations recommended granting permission to CMC, Vellore for conducting the phase-4 clinical trial covering 300 healthy volunteers for mixing of COVID-19 vaccines Covaxin and Covishield. The aim of the study is to assess whether a person can be given two different vaccine shots — one each of Covishield and Covaxin — to complete the inoculation course,” the source said.

The expert group also discussed the application by Biological E for conducting Phase 2/3 clinical trial of its COVID-19 vaccine in the paediatric population aged 5 to 17 years, along with the safety and immunogenicity data (after dose 1) from the ongoing phase 2/3 clinical trial on adults.

“After deliberation, the committee recommended that the safety and immunogenicity data from phase 2 part of the phase 2/3 clinical trial on adults should be submitted to the CDSCO (Central Drugs Standard Control Organisation),” the source said. It also suggested that the firm should submit the clinical trial protocol along with data for further review by the committee, the source said.

Dr. T●●●●z H●●●●●●i and 2 other likes this2 shares