New Delhi: On Thursday, a Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO) recommended that doses of Covishield and Covaxin vaccines be combined. Moreover, the expert panel recommended mixing Covaxin from Bharat Biotech with a nasal vaccine candidate, as well as clinical trials for Biological E’s Covid-19 vaccine on children. Final approval from the Drugs Controller General of India (DCGI) is still pending.
A request for carrying out a study on the mixing of doses of Covishield and Covaxin was submitted by Christian Medical College (CMC), Vellore. The expert panel recommended that CMC should conduct clinical trials on this application.
‘The expert committee recommended that CMC, Vellore be given permission to conduct the Phase-4 clinical trial covering 300 healthy volunteers for the mixing of Covid-19 vaccines Covaxin and Covishield,’ the news agency reported, quoting an unnamed source.
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It noted that the purpose of this study is to test whether a person can receive two different vaccine shots — one each of Covishield and Covaxin — to complete the vaccination course.
Apart from this, the expert committee also recommended allowing Hyderabad-based Bharat Biotech to study the interchangeability between Covaxin and a nasal vaccine candidate in clinical trials, BBV154.
The panel has requested that Bharat Biotech remove the word ‘interchangeability’ from its study title, as well as submit a revised study protocol for its approval.
The third major recommendation by the expert panel was to recommend that Biological E proceed with phase 2 and 3 clinical trials of its Covid-19 vaccine candidate on children (age 5 to 17). However, the committee requested more information from ongoing studies of those over 18 years, even though it has not yet rejected the application.
This is the fourth vaccine to receive the recommendation to conduct clinical trials on children after today’s announcement. The three others are those developed by Bharat Biotech, Zydus and Novavax.
In addition, the expert committee was supposed to discuss the Phase-3 clinical trial application filed by Johnson and Johnson (J&J) for its single-dose Covid-19 vaccine in India. However, the panel has been informed that the company has withdrawn its proposal, according to the media.
Johnson and Johnson sought approval to conduct a Phase-3 clinical trial of its vaccine on approximately 600 participants between the ages of 18 and 59 and those aged 60 and over. This study was performed to evaluate the safety, immunogenicity and reactogenicity of its vaccine on healthy adults in India.
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