Serum Institute of India (SII) will submit data from the two full doses’ clinical trials in the country to the Indian regulator within the planned timeline.
Sources said the UK partner, AstraZeneca, would also submit the current data set to the regulator as planned, and provide additional test results, if sought. If the Indian regulator seeks additional data on a wider population for the primer-booster dose regimen, then it can delay timelines.
SII is on track with the 1,600 subject clinical trials in India with two full doses and there have been no manufacturing errors or other issues with the