India okays Covovax vaccine trial in children |
An expert panel of India`s Central Drug Authority on 28th July recommended granting permission to Serum Institute of India (SII) for conducting phase 2 and 3 trials of Covid vaccine Covovax on children aged 2 to 17 years with certain conditions. The trials would cover 920 children, 460 each in the age-group of 12-17 and 2-11 across 10 sites. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated on the revised study protocol application given by SII on 28th July. SII revised protocol requested inclusion of pediatric cohort in the ongoing Covovax phase 2 and 3 observer - blind, randomised, controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the jab. SII has stated that globally, all adults aged 18 and above are being vaccinated and after this population is protected against COVID-l9, children will remain the most susceptible group. It has also been predicted that the third wave of the pandemic may affect children in the country. Moreover, until all age groups, including children are covered under vaccination. the SARS-CoV-2 virus may remain in circulation, keeping everyone at risk of severe disease. Several companies have already started evaluating the safety and immunogenicity of COVID-19 vaccines in the pediatric population. Reports say that Indian Health Ministry hopes to expect a vaccine soon for children. In the ongoing Phase 2/3 study in India, more than 1400 participants have received at least first dose of the vaccine with no safety concerns reported so far.
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