Why haven't COVID-19 vaccine trials stopped? DCGI asks Serum Institute over safety concerns
Sputnik vaccine
Drugs Controller General of India (DGCI) has issued a show-cause notice to Serum Institute, the world's third largest vaccine manufacturer over safety issues in COVID-19 vaccine trials. DGCI has asked Serum Institute why trials of Covishield were not stopped in India even when the same vaccine-candidate caused illness in one of the participants of the trials.
Trials of the vaccine in the UK were put on hold after after one of the participants developed an unexplained illness. The vaccine is being developed by AstraZeneca and Oxford Univesrity.
"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," a spokesperson said earlier on Wednesday.
The company spokesperson also added that in large trials, illnesses will sometimes happen by chance but must be reviewed independently.
Serum Institute, which has been conducting trials of the vaccine in India, said on Wednesday (September 9) that they encountered "no issues".
"We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing & we have faced no issues at all: Serum Institute of India on reports on AstraZeneca halting the trials," Serum Institute was quoted as saying by ANI.