New Delhi, Sept 16: The Pune-based Serum Institute of India (SII) on Wednesday got the go ahead of the Controller General of India (DCGI) for resumption of human trials of the Covid-19 vaccine in India.
The Serum Institute is conducting the second and third phase of human trials in India for the Corona vaccine being developed jointly by the Oxford University of Britain and pharmaceutical company AstraZeneca. On September 6, AstraZeneca stopped all on-site testing after a volunteer suffered a spinal problem during ongoing testing for the vaccine in the UK.
In India, however, the SII continued the trials and subsequently halted it on September 10 on DCGI’s instructions.
DCGI, while allowing the tests to resume, directed SII to exercise extreme caution during the test and asked for additional information in the volunteer’s approval form and to closely monitor the problems encountered during and after the test.
SII is also required to provide complete information regarding the vaccine and medicines given during the test at DCGI’s office.