Covid Vaccine: Expert committee seeks more data from Serum Institute, Bharat Biotech for approval

New Delhi: The Subject Expert Committee (SEC) of the drug regulator did not clear applications of Serum Institute of India (SII) and Bharat Biotech seeking marketing approval for their Covid-19 vaccines at its meeting on Wednesday and asked them to provide updated data, people aware of the deliberations told ET. Pfizer, which had also submitted an application, did not make a presentation to the panel and sought more time to do so.According to the minutes of the meeting, the 10-member panel said SII should submit the outcome of the assessment of AstraZeneca-Oxford University trials done by the UK drug regulator. It noted that SII had been granted approval to conduct phase-2 and 3 trials in the country on the condition that the data generated from these shall be considered along with the data from the Oxford trials. AstraZeneca’s proposal for emergency use authorisation is under evaluation by the UK regulator.The panel also said SII has submitted safety data till November 14 and asked for updated safety as well as immunogenicity data from clinical trials in India and the UK.‘Part of the Process’In the case of Bharat Biotech, the committee said the company had presented interim safety and immunogenicity data for phase-1 and phase-2 trials. It recommended that the firm submit safety and efficacy data from the ongoing phase-3 trials.The committee will meet again after fresh data is submitted by the companies. An SII official said demand for more data was “part of the process”. Bharat Biotech declined comment.Health secretary Rajesh Bhushan had on Tuesday said India’s drug regulator may grant marketing approval to one or more Covid-19 vaccines in the next few weeks. The panel’s decision to not approve the applications on Wednesday could potentially delay the launch of the much-awaited vaccines in the country, but the chances of it giving them a green signal at the first instance were always remote. The committee needs to be fully satisfied about the safety and efficacy of the jabs before it approves them. Phase-3 trials of both SII’s Covishield and Bharat Biotech’s Covaxin vaccines are currently underway.Experts said it’s time to act with diligence and not in haste. “Incomplete data sets may show promise but unless full data is available, regulatory clearance would be premature. The onus is on the applicants to satisfy regulators beyond any doubt,” said Public Health Foundation of India president K Srinath Reddy.

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