Safety monitoring board - Latest News Update, Information, Photos & Videos on Safety monitoring board at Lokmat Times

The Russian made Covid-19 vaccine Sputnik V has met the primary endpoint of safety in the phase-2 clinical trials in India and has been recommended to continue the clinical trial without any modifications, according to an official statement.Dr Reddy's Laboratories Ltd said in a release that the Data and Safety Monitoring Board (DSMB) concluded that no safety concerns were identified and the study has met the primary endpoints of safety."Dr Reddy's Laboratories Ltd. announced today that the independent Data and Safety Monitoring Board (DSMB) has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continue the clinical trial without any modifications," the release said."The phase 2 study of Sputnik V was conducted on 100 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety. Further, the safety data has been submitted to the Drugs Controller General of India (DCGI) for review and approval to continue phase 3 clinical trials," the release added.G V Prasad, Co-chairman and Managing Director, Dr Reddy's Laboratories said, "The Indian clinical trial being conducted by Dr. Reddy's and RDIF is an adaptive design phase 2/3 trial. It is a bridging study to the larger global phase 3 study on 31,000 subjects. The phase 2 study in India showed a very good safety profile.""We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India," Prasad added.Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, "The safety data from the phase 2 clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets. The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on safe human adenoviral vector platform."In September 2020, Dr Reddy's and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India, the release said.As per the release, Sputnik V currently ranks among top 10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Orgzation's (WHO) list.The vaccine's efficacy is confirmed at 91.4 per cent based on data analysis of the final control point of clinical trials in Russia, the release said. Currently, the vaccine's clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.( With inputs from ANI )Disclaimer: This post has been auto-published from an agency feed without any modifications to the text and has not been reviewed by an editor

Home

City

Latest News

Cricket

LT Premium

National

International

Maharashtra

Opinions

Chhatrapati Sambhajinagar

Nagpur

Entertainment

Photos

Business

Technology

Sports

Lifestyle

Social Viral

Lokmat Games

Health

Pahalgam Terror Attack

Tahawwur Rana

IPL 2025

CM Devendra Fadnavis

Mumbai Local

Weather Update

Safety Monitoring BoardFOLLOW

Safety monitoring board, Latest News

Health :Covid: Pfizer vax for 2 to 4 year-olds fails to produce expected immunity

New York, Dec 18 The Covid vaccine developed for small children aged 2 to 4-year-olds by US drug ... ...

International :AstraZeneca revises vaccine efficacy to 76 per cent after dispute over US study

UK-Swedish drugmaker AstraZeneca on Thursday reasserted effectiveness of its vaccine after recalculating data from the disputed US study, albeit revising its efficacy in preventing symptomatic coronavirus cases down by three percentage points to 76 p ...

Health :After snub, AstraZeneca to share latest data on US vax trials

New York, March 23 Following the doubts expressed by a top US-based health agency over the Covid-19 vaccine ... ...

National :Russian COVID vaccine Sputnik V meets primary safety endpoint in phase-2 clinical trials in India

The Russian made Covid-19 vaccine Sputnik V has met the primary endpoint of safety in the phase-2 clinical trials in India and has been recommended to continue the clinical trial without any modifications, according to an official statement. ...