We are perplexed at the abrupt change in thinking of the SEC, says Drug Action Network
The threat from a ‘mutated’ coronavirus appears to have overnight helped the Bharat Biotech secure an emergency use permission for Covaxin, a perusal of meeting records show. From December 30 to January 2 that saw three marathon meetings, the Subject Expert Committee (SEC) of the Drug Controller General of India, that evaluates applications by vaccine companies for approval, changed its stance from insisting on efficacy data — that establishes proof of protection of the Covaxin — to approving it for emergency use under “clinical trial mode”, without the data it had been insisting on at least since December 9.
The minutes of the meeting of the SEC, made public on Tuesday, show that the committee had on December 30 directed the company to provide updated “safety, immunogenicity and efficacy data” from its ongoing Phase-3 trial. It was scheduled as a placebo-controlled trial involving about 25,800 volunteers across the country where some get the actual vaccine and some don’t.
The next meeting on Thursday, when the SEC approved the Serum Institute’s Covishield vaccine, the committee doesn’t appear to have considered additional data. It relied on safety and immunogenicity data as well as data on “severe adverse events” from the ongoing Phase 3 (without specifying how many). This data was furnished on December 30 too, and again the committee recommended that the Bharat Biotech “expedite the recruitment and perform an interim efficacy analysis for further consideration of restricted emergency use approval”.
Just a day later, at another meeting of the committee on January 2, the company presented “further updated data [it isn’t mentioned what] and requested that their proposal be considered in the “wake of incidence of new mutated coronavirus infection”.
Here the committee accorded its approval, though specifying that this be done only in clinical trial mode. Balram Bhargava, Director General, ICMR — a partner in the Covaxin project — said at a press briefing on Tuesday the clinical trial mode implied that there would be no placebo shots. Everyone eligible would be given the actual vaccine and would be followed up for reports on adverse events, like in a trial.
The All India Drug Action Network (AIDAN) said in a statement, “We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which approval was recommended while apparently discounting the need for efficacy data.”
Krishna Ella, Chairman, Bharat Biotech had said on Monday the Phase-3 trial would continue and efficacy data would be available in March. He said a scientific publication from his company was forthcoming within a week on the Covaxin strain’s response to mutated SARS CoV-2.
ICMR scientist Samiran Panda had told The Hindu earlier that a whole inactivated virus was likely to confer protection against a wider range of strains as more parts of its were exposed to the immune system likely making it more sensitive to a response. However, other scientists say in the absence of efficacy data there was no evidence to believe that this was the case.
In a presentation on Tuesday, Renu Swarup, Secretary, Department of Biotechnology, said an analysis of SARS CoV-2 mutations had found 79 cases, all from travellers in the United Kingdom. However, there was no “scientific evidence” to suggest that the strain had higher infectivity.
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