Within 24 hours of last week, an expert committee from the national drug regulator changed its decision on whether Bharat Biotech’s Covid-19 candidate vaccine could be recommended for approval without evidence of its efficacy in humans, the minutes of the committee meetings held on January 1 and 2 show.
The Subject Matter Experts Committee (SEC) recommended restricted-use approval for Covaxin on January 2. The Controller General of Medicines of India (DCGI) Dr VK Somani approved the candidate for emergency restricted use the following morning.
Bharat Biotech President and Managing Director Dr. Krishna Ella responded to critics of the emergency approval on Monday, asking why global trial data for AZD1222, a variant of the Covishield vaccine produced by the Serum Institute of India based in Pune, were not being questioned. Similary.
On January 1, the SEC that investigated Bharat Biotech’s application for approval noted that Covaxin had the “potential” to target mutated coronavirus strains; however, the data presented by the company at the time was not convincing enough for the panel to recommend approval of restricted emergency use. .
On January 2, however, the committee recommended approval, citing efficacy data from a challenge study in non-human primates.
“The data generated so far demonstrate a strong immune response (both antibodies and T cells) and viral neutralization in vitro. The ongoing clinical trial is a large trial on 25,800 Indian subjects that has already enrolled 22,000 subjects, including subjects with comorbid conditions, and has demonstrated safety to date, ”read the minutes of the SEC meeting of 1 December. January.
“However, the effectiveness has not yet been proven,” the minutes read. The minutes show that after “detailed deliberation”, the SEC asked Bharat Biotech to “try to accelerate the recruitment” of volunteers in its ongoing phase 3 human trials. The panel also recommended that the company conduct an “interim efficacy review for further consideration” of its request for emergency restricted use approval.
However, on January 2, the SEC recommended restricted approval “in clinical trial mode” after the Hyderabad company requested consideration of its proposal “following the incidence of a new mutated coronavirus infection.”
The SEC minutes read: “… (The) company has submitted the safety and efficacy data from the challenge study with non-human primates where the vaccine was found to be safe and effective.”
They say: “As the committee already pointed out, this vaccine is an Inactivated Full Virion, CoronaVirus Vaccine that has the potential to attack mutated coronavirus strains.
“In view of the above, after detailed deliberation, the committee recommended granting the permit for restricted use in emergency situations of public interest as an abundant precaution, in clinical trial mode, to have more vaccination options, especially in case of mutant infection are. In addition, the company will continue the ongoing phase III clinical trial and will send data arising from the trial when available. “
In requesting approval, Bharat Biotech had submitted “updated data” and “justification,” the minutes said. However, the minutes do not record the nature of this data and its justification.
In her virtual briefing on Monday, Dr. Ella said in response to a question from The Indian Express: “We have not submitted any interim efficacy data. What we’ve done is produce (data on the) higher antibody response, long-term immunogenicity, and neutralization protection. “
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