Vaccine major Serum Institute of India (SII) will require clearance from the Data and Safety Monitoring Board (DSMB) in the UK and DSMB India before resuming recruitment for conducting COVID-19 trials for the Oxford-AstraZeneca coronavirus vaccine in India, an order issued by the Drugs Controller General (India) and the Central Licensing Authority said.
DCGI Dr VG Somani also ordered the Serum Institute to suspend any new recruitment in Phase 2 and 3 clinical trials until further notice. The direction came after SII submitted to the DCGI it paused trials after its show-cause notice and that it's reviewing the overall situation. The SII had started Phase 2/3 trials after recruitment of 1,600 volunteers across 17 centres, each with about 100 volunteers, in India. In its notice, the DCGI had asked the SII as to why the clinical COVID-19 vaccine trials for Oxford-AstraZeneca coronavirus vaccine were not stopped even after patient safety concerns surfaced.
The DCGI, in its new order, has asked the SII to increase the safety monitoring of the test subjects vaccinated under the trials so far, and submit the plan and the final report.
Notably, 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 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 issue erupted after AstraZeneca put a pause on Phase 3 COVID-19 trials on Tuesday after a UK patient fell ill. Though AstraZeneca described the pause as a "routine action", which must be done in case of an "unexplained illness" in any of the participants, it did not explain the nature of the illness. Following the DCGI notice on Wednesday, Serum Institute paused trials on Thursday.
Meanwhile, AstraZeneca CEO Pascal Soriot expressed hopes that the company would soon resume the trials after reviewing the cause of the illness in the patients and that the company is still aiming for the Oxford COVID-19 vaccine by the year-end.
If AstraZeneca gets approval to resume trials soon, SII could also aim to launch the vaccine by the year-end, suggest experts. As per its earlier plan, Serum Institute had 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.