CDSCO expert panel recommends nod to study on mixing doses of Covaxin, Covishield

The panel also recommended allowing Bharat Biotech to study the interchangeability of Covaxin and its adenoviral intranasal vaccine candidate

The subject expert committee of India's drug regulator has recommended granting permission to Christian Medical College, Vellore to carry out studies on mixing doses of Covishield and Covaxin.

The Vellore-based research institute had sought permission for conducting Phase IV clinical trials of mixing Covaxin and Covishield doses.

Experts believe that combining different vaccines is important to study their efficacy against different strains of coronavirus and their safety.

The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) also sought more information from Biologicals E which had sought permission to conduct Phase II/III clinical trial of Covid-19 vaccine in the age group of 5-17 years.

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“The committee noted that the vaccine is under Phase II/III clinical trial in age group of 18 years and more, and full safety and immunogenicity data is not ready for assessment,” an official said.

The committee also asked the firm to submit the clinical trial protocol along with data for further review by the committee.

It 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 firm to remove the word “interchangeability” from the study title and submit a revised protocol for approval.

Meanwhile, Johnson and Johnson (J&J) withdrew its appliation seeking permission to conduct phase-3 clinical trial of its single-dose Covid-19 vaccine.

J&J had sought approval for conducting phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups – those between 18 and 59 years, and 60 years and above – to evaluate the safety, reactogenicity, and immunogenicity of the jab in healthy Indian adults.