A press release from the vaccine maker said a phase II/III study has been accepted and published in The Lancet Infectious Diseases, a peer-reviewed, high-impact factor journal.
The DGCI has directed Bharat Biotech to submit safety data including the data on adverse events with proper analysis within a span of 15 days for the first two months.
The company has been asked to submit safety data including data on adverse events with due analysis every 15 days for the first two months and monthly after upto 5 months.