Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) approved a trial that involves mixing Covishield and Covaxin vaccines. The government panel allowed Vellore's Christian Medical College (CMC) to conduct a clinical trial covering 300 healthy volunteers for mixing of both the indigenously produced vaccines.
This study will be conducted to assess whether a beneficiary can be administered one shot each of Covishield and Covaxin to complete the vaccination course. This trial will be conducted in two groups-the first group will be given Covishield as the first dose and Covaxin as the second dose while the second group will get Covaxin as the first dose and Covishield as the second dose.
Besides this, the expert committee has also recommended granting approval to Hyderabad's Bharat Biotech for conducting a study on the interchangeability of Covaxin and an undertrial nasal vaccine candidate BBV154. The SEC also asked the firm to get rid of the word 'interchangeability' from the study title and submit a revised study protocol for its approval.
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Besides this, the expert panel also deliberated on Biological E's application for conducting phase 2/3 clinical trials of its COVID-19 vaccine for children between 5-17 years combined with safety and immunogenicity data after the first dose from the ongoing phase 2/3 clinical trial on adults.
After this recommendation, Biological E's COVID-19 jab will be the fourth vaccine to get SEC's nod to conduct clinical trials on children after the ones developed by Zydus Cadila, Novavax, and Bharat Biotech.
The panel was to discuss US-based pharma firm Johnson & Johnson's (J&J) application seeking permission to conduct Phase-3 clinical trials of its single-dose COVID-19 vaccine in India, news agency PTI reported. The firm, however, told the panel that they are withdrawing their proposal.
This trial was aimed to ascertain safety, reactogenicity, and immunogenicity of the vaccine in Indian healthy adults and comprised approximately 600 participants in two age groups-those between 18-59 years of age and those aged 60 and above.
Edited by Mehak Agarwal; with PTI inputs
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