<p>The Covid-19 vaccine makers of India, the Serum Institute of India and Bharat Biotech have to provide more data to the regulators before their vaccines get the green light. The subject experts committee (SEC), a panel made by the Drug Controller General of India (DCGI), requires additional data to consider approving the vaccines.</p>.<p><strong>Covishield</strong></p>.<p>This vaccine candidate has been developed by the Serum Institute of India (SII) based in Pune. The institute submitted its proposal for authorization of emergency usage along with safety data from its Phase 1, 2 and 3 clinical trials where were conducted in India. It has also provided the SEC with safety data from clinical trials held in the UK.</p>.<p>The committee will also be considering data and results from the clinical trial held in Oxford. The institute has submitted data until November 14, as per a report by <a href="https://www.moneycontrol.com/news/coronavirus/explained-why-dcgi-set-aside-emergency-approvals-of-serum-institute-bharat-biotech-covid-vaccines-6210281.html">Moneycontrol</a>.</p>.<p>"After detailed deliberation, the committee recommended that the firm should submit the following data/information for updated safety data of the Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK MHRA for grant of EUA," DCGI said.</p>.<p>SII has sought approval from the regulators with its partners, Oxford-AstraZeneca. The institute is conducting Phase 2 and 3 trials for Covishield in India at present.</p>.<p><strong>Covaxin</strong></p>.<p>Bharat Biotech’s vaccine candidate, Covaxin, met a similar fate when it was presented before the SEC. The committee has asked for additional data on the safety and efficiency of the vaccine.</p>.<p>The company presented safety data from its Phase 1 and 2 trials conducted in India but the SEC has asked for data from the ongoing Phase 3 clinical trials.</p>.<p><strong>Pfizer’s candidate</strong></p>.<p>Pfizer has asked for more time to prepare a proposal before the committee, which is why the SEC will not be looking at Pfizer’s vaccine candidate yet.</p>
<p>The Covid-19 vaccine makers of India, the Serum Institute of India and Bharat Biotech have to provide more data to the regulators before their vaccines get the green light. The subject experts committee (SEC), a panel made by the Drug Controller General of India (DCGI), requires additional data to consider approving the vaccines.</p>.<p><strong>Covishield</strong></p>.<p>This vaccine candidate has been developed by the Serum Institute of India (SII) based in Pune. The institute submitted its proposal for authorization of emergency usage along with safety data from its Phase 1, 2 and 3 clinical trials where were conducted in India. It has also provided the SEC with safety data from clinical trials held in the UK.</p>.<p>The committee will also be considering data and results from the clinical trial held in Oxford. The institute has submitted data until November 14, as per a report by <a href="https://www.moneycontrol.com/news/coronavirus/explained-why-dcgi-set-aside-emergency-approvals-of-serum-institute-bharat-biotech-covid-vaccines-6210281.html">Moneycontrol</a>.</p>.<p>"After detailed deliberation, the committee recommended that the firm should submit the following data/information for updated safety data of the Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK MHRA for grant of EUA," DCGI said.</p>.<p>SII has sought approval from the regulators with its partners, Oxford-AstraZeneca. The institute is conducting Phase 2 and 3 trials for Covishield in India at present.</p>.<p><strong>Covaxin</strong></p>.<p>Bharat Biotech’s vaccine candidate, Covaxin, met a similar fate when it was presented before the SEC. The committee has asked for additional data on the safety and efficiency of the vaccine.</p>.<p>The company presented safety data from its Phase 1 and 2 trials conducted in India but the SEC has asked for data from the ongoing Phase 3 clinical trials.</p>.<p><strong>Pfizer’s candidate</strong></p>.<p>Pfizer has asked for more time to prepare a proposal before the committee, which is why the SEC will not be looking at Pfizer’s vaccine candidate yet.</p>