COVID-19 Vaccine: Serum Institute Gets DCGI Nod To Resume Trials
New Delhi: The Drugs Controller General of India (DCGI) has given permission to Serum Institute of India, a Pune-based vaccine maker, to resume the Phase 2 and Phase 3 clinical trials of the COVID-19 vaccine in the country.
DCGI had halted Serum’s ongoing COVID-19 vaccine trials in India on September 9 after Serum’s partner AstraZeneca halted trials following a participant falling ill.
Serum is partnering AstraZeneca to carry out trials and manufacture the Oxford University’s COVID-19 vaccine doses in India, Financial Express reported.
Serum was in the process of recruiting 1,600 participants for the India trial and had started administering the shots across the 17 trial sites across the country.
The DCGI had also pulled up Serum for failing to inform it about AstraZeneca pausing the clinical trials and failing to submit a casualty analysis of the serious adverse event.
Subsequently, AstraZeneca received regulatory clearance for resuming trials in the UK after confirmation by the Medicines Health Regulatory Authority that the trials were safe.