English News


Serum Institute to resume Oxford corona vaccine trials

<p style="font-weight: 400;">The Serum Institute of India (SII) will resume the clinical trial of the Oxford Covid-19 vaccine candidate, Dr V.G. Somani, Drug Controller General of India (DCGI), said today.</p>
<p style="font-weight: 400;">The DGCI has revoked its earlier order of suspending any new recruitment for phase two and phase three trials of the vaccine.</p>
<p style="font-weight: 400;">On September 10, the DGCI had suspended the new recruitment following participants in the UK reported a suspected severe adverse reaction when administered a booster dose of the vaccine candidate.</p>
<p style="font-weight: 400;">On September 11, the DCGI had further directed SII to suspend any new recruitment in phase two and three clinical trials of the Oxford Covid-19 vaccine candidate till further orders against the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of "an unexplained illness" in a participant in the study.</p>
<p style="font-weight: 400;">Consequently, the DGCI also issued a show-cause notice to the SII, asking them to explains why the institute decided to go ahead with the clinical trials of the Covid-19 vaccine candidate while doubts about patient safety are yet unclear.</p>
India is the manufacturing partner of the vaccine candidate named Covishield, developed jointly by the University of Oxford's Jenner Institutes and AstraZeneca. The Pune-based firm is looking after the trials at 17 trial sites across India.
<p style="font-weight: 400;">The permission to resume the trials comes three days after AstraZeneca announced that it has resumed trials in the UK.</p>
<p style="font-weight: 400;">India reported 90,123 cases and 1,290 deaths yesterday. India now stands second nation after the US in the world to cross the five-million mark. The total number of reported corona cases is 5,020,360 and deaths 82,066.</p>
<p style="font-weight: 400;">(with agency inputs)</p>.