Bharat Biotech submits Covaxin phase 3 trial data to DGCI before meeting with WHO
New Delhi: Amid concerns over the effectiveness of Covid vaccines, the Hyderabad-based Bharat Biotech has submitted phase III trial data of Covaxin to Drugs Controller General of India (DCGI).
Phase-III trial data is also required for getting emergency use listing (EUL) from the World Health Organisation (WHO). Bharat Biotech is also scheduled to hold its pre-submission meeting with the World Health Organization (WHO) on Wednesday. Ith is part of the process for WHO emergency use listing and approval of its Covid vaccine.
Covaxin is one of the three vaccines being used in India’s vaccination programme against COVID-19 currently.
Trial data for phase-III is crucial as it will provide details of the efficacy of the vaccine, which was developed in association with the Indian Council of Medical Research (ICMR).
It is to be noted that in January, DCGI had granted permission for emergency use of Covaxin on the basis of its phase-I and phase-II clinical trial data.
Bharat Biotech submitted Phase 3 clinical trials data of COVAXIN to Drugs Controller General of India (DCGI) over the weekend: Govt sources pic.twitter.com/ggXSxQCaAc
— ANI (@ANI) June 21, 2021