Panel seeks more vaccine data before emergency nod

The SEC also cleared conditional permission for Phases 1 and 2 trials of the Covid-19 vaccine candidate developed by the Pune-based Gennova Biopharmaceuticals Ltd in collaboration with HDT Biotech Corporation, USA. The Department of Biotechnology had earlier said it had provided seed funding for the development of the mRNA-based vaccine candidate.

As per the minutes of the SEC meeting, the SII was asked to submit, specifically, safety data on Phase 2/3 clinical trials in India of its vaccine candidate named Covishield, developed by Oxford-AstraZeneca; immunogenicity data from the clinical trial in the UK and India; as well as the outcome of the UK regulatory authority’s assessment regarding its emergency use authorisation application. The expert committee noted that the SII has only “submitted safety data till November 14”, and that the principal investigator of its study, Dr Sushant Meshram, who is involved in the trials, did not attend the meeting.

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Bharat Biotech, which is currently conducting Phase 3 trials on its indigenous vaccine candidate Covaxin, has only submitted interim safety and immunogenicity data of its Phase 1 and 2 trials in the country. After its presentation on Wednesday, the SEC told it to “present the safety and efficacy data from the ongoing Phase 3 clinical trial for further consideration”.

“Both Bharat Biotech and Serum Institute said they will come back with the data sought,” sources said, adding that all three firms had been given separate slots to appear before the panel and Pfizer had sought a later date to submit data regarding the vaccine it has developed with German firm BioNTech, which has not been tested in India. “Their experts in the US were not available,” a source said.

Queries sent to the SII and Pfizer remained unanswered, while Bharat Biotech declined to comment on the meeting.

Bharat Biotech began its Phase 3 trials only in mid-November, and has presented interim data from early Phase 1 to mid-stage clinical trials for Covaxin on 1,125 participants. It has also “to some extent” submitted data from its ongoing Phase 3 trials on 25,800 participants, but this was not seen to be adequate by the SEC, a source said. Bharat Biotech’s Phase 3 trials are expected to continue until February 2021.

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The SII has submitted efficacy data from the trials being conducted abroad (the UK, Brazil and South Africa) as well as in India for its vaccine, and safety data from late-stage trials in India. A senior government official said the Pune-headquartered firm had only submitted interim safety data from its Phase 2, 3 trials on 1,600 participants and supplemented it with additional data from global trials.

Pfizer, which has received emergency authorisation use for its Covid-19 vaccine in the UK, with the first doses given out on Tuesday, had approached the DCGI with a request to waive the need for clinical trials in India. According to the New Drugs and Clinical Trial Rules, 2019, a company can seek such a waiver if the product is approved and marketed in certain countries.

While Phase 1 of human clinical trials provides details on safety of a vaccine candidate, Phase 2 determines its immunogenicity, or the ability to trigger an immune response. Phase 3 reveals crucial information on the efficacy of a vaccine candidate.

Sources said the SEC would also do a detailed scrutiny of biochemistry data, laboratory data, and animal data regarding the vaccines, apart from human clinical trial data.

On Tuesday, ICMR Chief Dr Balram Bhargava said that in an extraordinary situation of a pandemic, the regulator looks at the risk-benefit ratio to grant a temporary licence. “The benefit has to be more than the risk,” Bhargava said.