The Drugs Controller General of India (DCGI) has allowed the Pune-based Serum Institute of India (SII) to resume the second and third phase trials of the oxford’s COVID-19 vaccine in India.
Britain has stopped the trials of the vaccine after the health of a person involved in the trials deteriorated. Now the trial started there again. After this incident, the drug controller in India also stopped the trial on 11 September.
DCGI wrote a letter to Serum Institute:
DCGI VG Somani, in a letter to the Serum Institute of India (SII), stated that the response of the institute has been carefully examined as per the recommendations of DSMB in India and the UK.
According to the letter, ‘”You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the Data Safety Monitoring Board (DSMB), India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up.”
Second and third phase trials are currently underway in India:
According to the Serum Institute, “The second and third phase trials are currently underway in the country. The trial of this vaccine has reached the third stage in the world. More than 50 thousand people have participated in it. After the trial, the work of clearing the safety and bearing data will remain.”
The Serum Institute of India (SII) had request permission to resume trials in India. He presented the recommendations of the Data Security Monitoring Board (DSMB), UK.
AstraZeneca stopped the ongoing trial earlier this month:
AstraZeneca previously stopped the ongoing trial of the coronavirus vaccine because a volunteer involved in the trial developed an unexplained disease.