CDSCO expert panel recommends nod to study on mixing doses

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

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

An expert panel of India’s central drug authority on Thursday 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,” a source said.

“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.

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It also suggested that the firm should submit the clinical trial protocol along with data for further review by the committee, the source said.

The application of Johnson and Johnson (J&J) seeking permission to conduct phase-3 clinical trial of its single-dose COVID-19 vaccine was on the agenda, but “the firm informed that they are withdrawing their proposal,” another official source said.

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

The firm has conducted clinical trials in the USA, Brazil and South Africa.

J&J’s single dose vaccine first received the emergency use authorisation (EUA) in Bahrain on 25 February 2021.

 
As of April 16, 2021, the vaccine has been approved in several countries/markets around the world, including the US and the EU.

READ MORE: Over 45.55 crore Covid vaccine doses administered in India so far

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