Activists question panel’s change in stance on Covaxin in four days

Health activists and patient groups have raised concerns about the “abrupt” manner in which the health ministry’s expert panel appeared to have changed its position in recommending approval of Bharat Biotech’s Covaxin.

  • Updated On Jan 6, 2021 at 06:47 AM IST
Read by: 100 Industry Professionals
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Health activists and patient groups have raised concerns about the “abrupt” manner in which the health ministry’s expert panel appeared to have changed its position in recommending approval of Bharat Biotech’s Covaxin.

The minutes of Dec 30, Jan 1 and Jan 2 meetings of the subject expert committee, put out by Drug Controller General of India, show that a day after the SEC noted that efficacy data for Covaxin was not available, it gave the go-ahead (on Jan 2) for restricted use of the vaccine citing efficacy data from non-human trials.

In the Jan 1 meeting, the committee noted that Bharat Biotech had submitted safety and immunogenicity data, but said “efficacy is yet to be demonstrated”, the minutes show. The committee recommended that “the firm should try to expedite recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval”.

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The committee said Covaxin had “potential to target mutated coronavirus strains” and the data generated so far demonstrated a strong immune response (both antibody as well as T cell).

  • Published On Jan 6, 2021 at 06:47 AM IST
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