Hindustan Times (Jammu)
WHAT THE GOVT SAID The Centre has exempted foreign-made vaccines from conducting local bridging studies before seeking emergency-use authorisation, provided they have been authorised by the World Health Organization (WHO) or authorities in the US, Europe, the UK and Japan
The move is a part of the Centre’s efforts to expand the basket of vaccines for domestic use, and hasten the pace and coverage of Covid-19 vaccination, the health ministry said
The decision came following the recommendations of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).
The first 100 beneficiaries of foreign vaccines s will be assessed for 7 days for safety outcomes before the doses are rolled out
WHAT IS BRIDGE STUDY?
A bridging study is a supplemental study executed in a new region to "build a bridge" with the foreign clinical data on safety, efficacy, and dose response.