Within 24 hours last week, an expert committee of the national drug regulator changed its decision on whether Bharat Biotech’s Covid-19 vaccine candidate could be recommended for approval without proof of its efficacy in humans, the minutes of the committee’s meetings held on January 1 and 2 show.
The Subject Expert Committee (SEC) recommended restricted use approval for Covaxin on January 2. The candidate was approved for restricted emergency use by Drug Controller General of India (DCGI) Dr V G Somani the following morning.
Bharat Biotech chairman and managing director Dr Krishna Ella had hit back at critics of the emergency approval on Monday, asking why data from global trials of AZD1222, a variant of the Covishield vaccine produced by Pune-based Serum Institute of India, was not being questioned similarly.
On January 1, the SEC looking into Bharat Biotech’s request for approval noted that Covaxin had the “potential” to target mutated coronavirus strains – however, data presented by the firm at that point was not convincing enough for the panel to recommend restricted emergency use approval.
On January 2, however, the committee recommended approval, citing efficacy data from a challenge study on non-human primates.
“The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralization. The ongoing clinical trial is a large trial on 25,800 Indian subjects in which already 22,000 subjects have been enrolled including subjects with comorbid conditions as well which has demonstrated safety till date,” say minutes of the SEC’s meeting of January 1.
“However, efficacy is yet to be demonstrated,” the minutes say. The minutes show that after “detailed deliberation”, the SEC asked Bharat Biotech to “try to expedite the recruitment” of volunteers in its ongoing phase 3 human trials. The panel also recommended that the company should carry out an “interim efficacy analysis for further consideration” of its application for restricted emergency use approval.
On January 2, however, the SEC recommended restricted approval “in clinical trial mode” after the Hyderabad firm requested consideration of its proposal “in the wake of incidence of new mutated coronavirus infection”.
The SEC minutes say, “…(The) firm has presented the safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective.”
They say: “As already noted by the committee, this vaccine is Inactivated Whole Virion, CoronaVirus Vaccine having potential to target mutated coronavirus strains.
“In view of above, after detailed deliberation, the committee recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. Further, the firm shall continue the on-going Phase III clinical trial and submit data emerging from the trial as and when available.”
In requesting approval, Bharat Biotech had presented “updated data” and “justification”, the minutes say. The minutes do not, however, record the nature of this data and justification.
At his virtual briefing on Monday, Dr Ella said in response to a question by The Indian Express: “We have not submitted any interim efficacy data at all. What we have done is, we have produced (data on the) highest antibody response, long-term immunogenicity and how neutralisation protection is there.”
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