The Comptroller General of Medicines of India (DCGI) has granted permission to the Pune Serum Institute of India (SII) to resume its phase two and three clinical trials of the Oxford Covid-19 candidate vaccine in the country.
DCGI VG Somani, in a letter to SII, has said that the institute’s response has been “carefully scrutinized” as well as the DSMB’s recommendations in India and the UK.
“You (SII) can restart the clinical trial dated August 2, 2020, as recommended by the Data Security Monitoring Board (DSMB), India as per the already approved protocol and the provisions set forth in the New Medicines Rules and Clinical Trials, 2019 subject to the aforementioned conditions that must be scrupulously followed, such as additional care during screening, additional information in the informed consent, and close monitoring of similar events during study follow-up, “said the letter as reported by the ANI news agency.
The DCGI has also asked the SII to present the details of the medication used according to the protocol for the management of adverse events.
The Pune-based company has also presented a summary of the seven-day safety follow-up after the first vaccination, stating that none of the subjects experienced serious adverse events as of the reporting date, and reported adverse events were noted to be mild. , solved by itself and had no sequel.
On September 11, the DCGI had directed the Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate until new orders occur in the context of pharmaceutical giant AstraZeneca. , which will pause clinical trials in other countries because of “unexplained illness” in a study participant.
AstraZeneca has already resumed trials of the vaccine in the UK.
SII, which partnered with AstraZeneca to make the candidate vaccine for COVID-19, received permission from India’s main drug regulator in August to conduct a phase 2/3 clinical trial of the ChAdOx1 nCoV-19 coronavirus vaccine ( recombinant) in several clinical trials sites in the country to determine its safety and immunogenicity.
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