DCGI orders Serum Institute to suspend recruitment in Oxford COVID-19 vaccine clinical trials

Drug Controller General of India (DCGI) Dr VG Somani has ordered Serum Institute of India (SII) to suspend any new recruitment in Phase 2 and 3 clinical trials for the Oxford-AstraZeneca coronavirus vaccine candidate till further notice. The direction comes close on the heels of SII's answer to a show-cause notice by the drug regulator asking why the clinical trials for the COVID-19 vaccine in question were not stopped even after patient safety concerns surfaced.

The DCGI also asked Serum Institute to increase the safety monitoring of the test subjects vaccinated under the trials so far, and submit the plan and report, news agency PTI reported. The vaccine manufacturer has also been ordered to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK and secure clearance from the DCGI's office in India before resuming recruitment in the trials in future.

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Serum Institute is working with British-Swedish biopharmaceutical giant AstraZeneca and Oxford University for manufacturing the COVID-19 vaccine candidate AZD1222. The Pune-based company had started manufacturing the vaccine, targeting to use in India and 92 other countries upon completion of trials and regulatory clearances. In India, the vaccine was to be marketed under the brand name Covishield.

The Indian drug controller had issued a show-cause notice to Serum Institute on September 9 for not informing it about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate in other countries, and also for not submitting casualty analysis of the "reported serious adverse events". The British-Swedish biopharmaceutical major AstraZeneca put a pause on the COVID-19 trials after a UK patient fell ill.

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AstraZeneca had described the pause as a "routine action", which must be done as part of the process in case of an "unexplained illness" in any of the participants. The company did not explain the nature of the illness. A New York Times report, however, attributed a person familiar with trials saying that one UK participant had 'transverse myelitis', an inflammation of the spinal cord which is normally caused by viral infections. It's not clear yet if this was in direct response to the vaccine.

Serum Institute on Thursday said it has paused trials after the DCGI show-cause notice. The company stated it reviewing the situation for now. It had started trials among 1,600 volunteers at 17 centres, each with about 100 volunteers, on August 22.

Serum Institute has promised to provide 400 million doses to low-and middle-income countries by 2020, and 1 billion doses in total. It aims to make over 6 crore doses per month of its vaccine candidate, which will be increased to 10 crore per month by April 2021.

Meanwhile, AstraZeneca CEO Pascal Soriot has said that the company is still aiming for the Oxford COVID-19 vaccine to be ready by this year-end.

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