The country's drug regulator on Tuesday allowed Serum Institute of India (SII) to resume trials of the AstraZeneca-Oxford vaccine candidate, Covishield, revoking its earlier order suspending new recruitments for phase two and three tests.
The resumption of trails was allowed after the vaccine maker submitted recommendations of the Data Safety Monitoring Board (DSMB), the UK, and DSMB, India. Giving permission, Drugs Controller General of India (DCGI) V G Somani said that SII’s reply had been "carefully examined".
The regulator, earlier, had asked SII to suspend volunteer recruitments for phase two and three clinical trials of Covishield and directed the firm to increase the safety monitoring of the subjects already vaccinated.
AstraZeneca resumed clinical trials in the UK last weekend after Medicines and Healthcare Products Regulatory Agency (MHRA) dubbed them “safe”. SII’s CEO Adar Poonawalla had then tweeted: “As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example of why we should not bias the process and should respect the process till the end. Good news, @UniofOxford.”
On September 6, global trials of the vaccine candidate were put on hold to allow the review of safety data by independent committees and international regulators after a volunteer fell sick with an unexplained neurological illness.
Somani had issued a show-cause notice to SII earlier this week, asking it to explain as to why the permission to conduct trials not be suspended unless patient safety is established. SII responded saying that DSMB noted no safety concerns from the Indian study.