A subject expert committee (SEC) has recommended that the country’s apex drug regulator grant approval to Bharat Biotech for conducting late-stage human trials of its Covid-19 vaccine candidate Covaxin in India.
“After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct Phase III clinical trial subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended …,” stated minutes of the SEC’s meeting on the matter dated October 20.
The SEC of the Central Drugs Standard Control Organisation (CDSCO) has recommended that once a suspect case is confirmed, the principal investigator at the trial site will evaluate the clinical information to classify it as a symptomatic case.
The committee has also set various criteria for a participant to be a confirmed symptomatic case confirmed by a positive RT-PCR test. This includes either one or more symptoms such as shortness of breath, new onset anosmia or aguesia, oxygen saturation levels of less than 94 per cent or pneumonia diagnosed by chest X-ray or CT scan, fever, chills and new cough. “The events not meeting the primary endpoint shall be categorized as secondary endpoints,” stated the minutes.
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