DCGI VG Somani, in a letter to the ISS, said the institute’s reaction had been “carefully revised” as DSMB’s recommendations in India and the United Kingdom.
“You (SII) will possibly restart the clinical trial as of August 2, 2020, as advised through the Data Security Monitoring Board (DSMB), India, in accordance with the protocol already approved and the provisions set forth in the regulations for new drugs and clinical trials, topic 2019 for the disputed situations that will have to be scrupulously respectable , such as the detection of additional precautions, the collection of more data in informed consent and close follow-up of similar occasions monitoring the study,” the letter says as reported through the ANI news agency.
THE DCGI also requested the SII to present the main points of the drug used in accordance with the protocol for the control of adverse events.
The Pune-based company also submitted a summary of the protection follow-up seven days after the first vaccination, indicating that no serious adverse occasions were experienced in any of the subjects up to the date of the report and that reported adverse occasions were reported. be mild, resolved on its own and with sequels.
On 11 September, DCGI ordered the Serum Institute of India to suspend any further recruitment in the phase two and 3 clinical trials of the Oxford COVID-19 vaccine candidate until further requests in the context of pharmaceutical giant AstraZeneca to postpone clinical trials in other countries due to an “unexplained disease” in a participant.
AstraZeneca has already resumed vaccine trials in the UK.
SII, which partnered with AstraZeneca to manufacture the COVID-19 candidate vaccine, was approved in August by India’s leading drug regulator for a phase 2/3 clinical trial of the ChAdOx1 nCoV-19 (recombinant) coronavirus vaccine in various clinical trials. protection and immunogenicity in the country.
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