Serum Institute of India said on Wednesday that trials of AstraZeneca Plc’s COVID-19 vaccine candidate in the country is ongoing and has not faced any issues.
AstraZeneca said it has paused global trials, including large late-stage trials, of its experimental coronavirus vaccine due to an unexplained illness in a study participant.
“We can’t comment much on the UK trials,” Serum Institute said in a statement, adding “as far as Indian trials are concerned, it is continuing and we have faced no issues at all.”
A spokesperson for the AstraZeneca vaccine said in a statement Tuesday that "we voluntarily paused vaccination to allow review of safety data by an independent committee. "This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."
The company said that in large trials, illnesses will sometimes happen by chance but must be reviewed independently.
Pune-based vaccine maker earlier shortlisted 17 sites in India for the Phase II clinical trial of COVID-19 vaccine. At least 1,600 candidates aged between 18 to 55, will participate in the trial.
Each participant will administer two doses in a gap of four weeks. First dose will be given on day one and second dose will be scheduled on day 29," according to the study design by Serum Institute of India.