Bharat Biotech’s vaccine against COVID-19, Covaxin, has been recommended by an expert panel for phase 2/3 clinical trials on 2-18-year-olds, according to a report by a agency PTI.
The trial will happen in 525 subjects at various sites, including AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech”s application seeking permission to conduct phase II/III clinical trials to guage the security , reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
“After detailed deliberation, the committee recommended for conduct of proposed clinical test |phase II|clinical trial|clinical test”> phase II clinical trial /III clinical test of whole virion inactivated coronavirus vaccine within the 2 to 18 years age bracket subject to the condition that the firm should submit the interim safety data of phase II clinical trial along side DSMB recommendations to the CDSCO before proceeding to phase III clinical trial a part of the study,” a source told PTI.
A vaccine works by mimicking a natural infection. A vaccine not only induces immune reaction to guard people from any future COVID-19 infection, but also helps quickly build herd immunity to place an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes resistant to a disease, making the spread of disease from person to person unlikely. the great news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
Earlier the proposal was deliberated within the SEC meeting dated February 24 and therefore the firm was asked to submit a revised clinical test protocol. Covaxin, indigenously developed by Bharat Biotech together with the Indian Council of Medical Research (ICMR), is getting used in adults in India”s ongoing COVID-19 vaccination drive.
