Expert panel recommends study on mixing Covid vaccines, looking at trials of Biological E jab on kids
The Subject Expert Committee of CDSCO has recommended conducting a study involving clinical trials to mix Covaxin and Covishield vaccines. If the proposal is approved by DCGI, the study will be conducted by Christian Medical College, Vellore. The panel is also looking at trials of Biological E Covid jab on children.
A Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) on Thursday recommended conducting a study on mixing doses of Covishield and Covaxin vaccines.
Apart from this, the expert panel also recommended mixing of Bharat Biotech's Covaxin and a nasal vaccine candidate, while saying they are looking at trials for Biological E's Covid-19 vaccine on children.
However, a final approval from the Drugs Controller General of India (DCGI) is awaited.
MIXING COVAXIN AND COVISHIELD
The application to carry out a study on mixing doses of Covishield and Covaxin was submitted by Christian Medical College (CMC), Vellore. While discussing the application, the expert panel recommended that CMC should conduct clinical trials on this.
"The 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," news agency PTI reported quoting an unnamed source.
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It added that the purpose of this study is to assess whether a person can be given 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 carry out a study on the interchangeability of its Covaxin and an undertrial nasal vaccine candidate BBV154.
The panel has however asked Bharat Biotech to remove the word "interchangeability" from its study title and submit a revised study protocol for its approval.
WHAT ABOUT BIOLOGICAL E's VACCINE?
Permission to Biological E to carry out Phase 2 and 3 clinical trials of its Covid-19 vaccine candidate on children (aged 5 to 17 years) is on hold for now. The committee has called for more data from the ongoing studies in those above 18 years, even though it has not rejected the application. The company has been asked to submit trial data, a source in the SEC said.
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JOHNSON & JOHNSON WITHDRAWS PROPOSAL
The expert committee was also supposed to discuss the application filed by Johnson and Johnson (J&J) that is seeking permission to conduct Phase-3 clinical trial of its single-dose Covid-19 vaccine in India. However, the company informed the panel that they are withdrawing their proposal, PTI reported.
Johnson and Johnson had sought approval for conducting Phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups: Between 18 and 59 years, and those aged 60 and above. This was to evaluate the safety, reactogenicity, and immunogenicity of its vaccine in healthy Indian adults.
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