New Delhi: The Narendra Modi government’s expert panel has asked vaccine maker Bharat Biotech to make a few changes to its proposal to conduct large trials using its indigenous Covid-19 vaccine, Covaxin.
The vaccine is being developed in collaboration with the country’s apex medical research body — the Indian Council of Medical Research (ICMR).
The Hyderabad-based firm had presented the phase 3 clinical trial protocol along with interim data of Phase 1 and 2 clinical trials before the government’s Subject Expert Committee (SEC).
The SEC advises the apex drug regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials.
The SEC, in a meeting on 5 October, found the design of phase 3 study submitted “in principle satisfactory”, but suggested a few clarifications.
The minutes of the meeting were made available on the Central Drugs Standard Control Organisation’s (CDSCO) website. The CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in the country.
While Phase 1 trial typically involves less than 100 people, phase 2 trial has 100 to 300 people enrolled. Phase 3 trials — for which the company had sought permission — generally enrols over 1,000 participants.
Identify the appropriate dose: SEC to Bharat Biotech
According to the minutes, the panel, “after detailed deliberation”, opined that “the design of the Phase 3 study is in principle satisfactory”.
However, it highlighted that some definitions, such as of asymptomatic patients, need more clarification.
Also, the panel has recommended the firm that the study “should be initiated with appropriate dose identified from the Phase 2 safety and immunogenicity data”.
Immunogenicity data shows the immune response provoked in the body after the vaccine dosing.
The firm has also been asked to submit safety and immunogenicity data from Phase 2 trial for consideration before the panel.
Covid vaccine candidate by Biological E asked to ‘revise proposal’
Another Hyderabad-based vaccine maker, Biological E, had presented a proposal to conduct Phase 1 and 2 clinical trial protocol before the committee.
However, the panel has recommended the firm to complete and submit “non-clinical toxicity data on rabbits”.
It has also suggested the firm to carry out ascending dose safety study starting with “15mcg dose, 25 mcg dose and 50mcg dose before proceeding to Phase II study”.
Moreover, it has instructed that “animal challenge studies should be carried out parallelly and accordingly, the firm should submit the revised protocol along with the animal toxicity data”.
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