Adverse effect of vaccine won't affect rollout: Govt

December 01, 2020 17:20

Health ministry updates: Rajesh Bhushan, Secretary, Health Ministry on being asked about the recent adverse event in the Serum Institute of India's vaccine trial: "Adverse event will not affect the timeline in any manner whatsoever. Whenever clinical trial starts, subjects are expected to sign prior informed consent form. This is global practice, it happens across all countries. Form tells subject about possible adverse events that may happen in case one decides to participate in trial.

"Clinical trials are multi-centric & multi-site. Each site has an Institutional Ethics Committee, which is independent of manufacturer or govt. In case of any adverse event, this Committee takes note and gives its report to Drug Controller General of India.

"Monitoring Board also monitors clinical trial from day to day basis and keep an eye on adverse events and report it. Drug Controller General analyses all reports and finds out whether there's a one-to-one co-relation between adverse event and vaccination.

"Adverse events do occur with drugs or vaccines or any other health intervention. It is the role of the regulator after collating all data to ascertain or refute whether there is a causal link between the event and intervention," ICMR DG Dr Balram Bhargava, said.

« Back to LIVE

TOP STORIES

PBKS not out of play-off race yet: Harshal

The pacer praised Prabhsimran Singh and Shashank Singh for helping PBKS recovering in the second inning after losing two quick wickets.

In Pictures - Narine fires KKR past LSG and to the top of IPL

Images from Sunday's IPL match between Kolkata Knight Riders and Lucknow Super Giants, in Lucknow.

Campaigning ends for third phase, high stakes for BJP

The stakes are significant for the BJP in this round as the party had in 2019 won an overwhelming majority of these seats, including all in Gujarat, Chhattisgarh, Bihar and Madhya Pradesh, that will go to polls on May 7.

In Pictures - Liverpool back on track with win over Spurs

A summary of Sunday's action in the Premier League.

Kangana's gaffe, slams 'Tejasvi Surya' in poll speech

Addressing a gathering in the Sundernagar area of Himachal Pradesh's Mandi on Friday, Ranaut -- the BJP candidate from the Mandi Lok Sabha seat -- while referring to the Indian National Developmental Inclusive Alliance (INDIA), said the...