Revoking its earlier order to suspend new recruitment for phase two and three trials, Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday, 15 September, granted the Serum Institute of India the permission to resume clinical trials of the Oxford COVID-19 vaccine candidate in the country.
Adar Poonawalla, CEO, SII said in a tweet, “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.”
Clinical trials for the AstraZeneca Oxford Coronavirus vaccine, AZD1222, have resumed in the UK, following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.
On 11 September, the DCGI had ordered the Serum Institute of India to suspend any new recruitment in phase two and three clinical trials of the Oxford COVID-19 vaccine candidate.
On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow the review of safety data by independent committees and international regulators, reported news agency IANS.
The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume, AstraZeneca said on 12 September.
Conditions on the Clinical Trial
The DCGI now has put certain conditions on the clinical trial. SII has been advised to take extra care during the screening, provide additional information in informed consent, and closely monitor for adverse events during a follow-up study which has to be “scrupulously” followed by the SII, reported news agency PTI.
The Serum Institute of India is the manufacturing partner of the COVID-19 vaccine among other world-wide vaccine manufacturers, to produce the vaccine currently under trial at the University of Oxford on a mass scale. SII is looking after the trials at 17 trial sites across India.
(With inputs from IANS and PTI)
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