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In January 2021, the Drugs Controller General of India (DCGI) granted permission to conduct the Phase III clinical trials for 28,216 Indian participants in the 12–99 age group. [15] [16] Of this, about 1,000 individuals were in the 12–18 age group. [17] [18] Interim results from the phase III trials were made available in July 2021. [19]
By September 2021, several companies had received approval to begin clinical trials on COVID-19 vaccines for children. [97] Discussions were also emerging over whether India would utilize vaccine booster doses, with the government having maintained that they were studying their applicability, and that they were focused on their goal to ...
COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy , effectiveness , and safety. As of November 2022 [update] , 40 vaccines are authorized by at least one national regulatory authority for public use: [ 1 ] [ 2 ]
A phase I clinical trial was carried out to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants. [4] The phase II concluded in April 2021. [12] [13] [14] In April 2021, the Drugs Controller General of India permitted the vaccine candidate to start phase III clinical trials. A total of 1,268 healthy ...
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness.
In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years. [48] The trials are conducted at AIIMS Delhi and Patna. [49] As many as 54 children had registered at the AIIMS Patna. [50] In total 525 participants are enrolled in the study as per clinical trial data. [51]
Companies conducting clinical trials in India often do so through a contract research organization. [39] Since the 2000s there has been recognition that India is an attractive place to grow an industry of drug research. [39] A 2008 report described the entry of multinational companies into India for clinical trials research as a frenzy. [40]
The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare.