Serum Institute resumes trials of Oxford University & AstraZeneca's COVID vaccine in India!
Galatta | Sep 16, 2020, 04:05 pm
There are very few vaccine candidates which are close to the final stages of coming to fruition, in the daunting fight against the COVID-19 Novel Corona Virus. However, it came as a setback when the trials of one such vaccine candidate being jointly developed by AstraZeneca and the Oxford University, which has been named AZD1222, had caused some unknown symptoms in one of the volunteers! The trials were immediately paused and after thorough investigation, it came to light that the volunteer had neurological issues and that seemed to be the reason behind the unknown illness. Following this, the trials were resumed in the UK. However, the trials for AZD1222, which were being conducted by the Serum Institute of India, were not allowed to resume by the Drug Controller Authority of India (DGCI).
Now, we hear that the DGCI has given the green light to Serum Institute, to continue the Phase 3 human clinical trials of the AstraZeneca vaccine candidate. As of now, the trials for this vaccine candidate have resumed in the UK, Brazil and South Africa but remain paused in the United States. A report states that the DCGI has allowed Serum Institute to resume the trials in India but with a few conditions. These conditions include increased safety monitoring and keeping the volunteers informed of new findings. A source from the DCGI states that the trials were allowed to resume only after detailed discussions with AstraZeneca and the health authorities from the UK, who had conducted the investigation into the volunteer who had developed the side effects.
Reports state that SII submitted the recommendations of the Data and Safety Monitoring Board (DSMB) UK and DSMB India to the DCGI and requested permission to restart enrolment for the trials. Following a thorough examination of the reports, the DCGI revoked its earlier order of suspending any new recruitment for Phase 2 and Phase 3 trials of the Oxford COVID-19 vaccine candidate, till further orders. We hear that SII has also submitted a summary of safety follow up of seven days following the first vaccination. This showed no adverse effects were experienced by any of the volunteers till the date of the report collection. Thus, the DCGI DR. VG Somani, went ahead and approved the resumption of clinical trials of the AZD1222 vaccine candidate, in India! Stay tuned for updates...