Recruitment of volunteers for the phase 2/3 clinical trial of COVID-19 vaccine Covovax among children aged 2 to 17 years began on Sunday at the Hamdard Institute of Medical Sciences and Research in New Delhi.
The trial would be held across 10 sites and would cover 920 children -- 460 each in the age groups of 12-17 and 2-11 -- according to official sources.
Indigenously developed Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D has received emergency use authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.
India's drug regulator in July had granted permission to Serum Institute of India (SII) for conducting a phase 2/3 trial of Covovax on children aged 2 to 17 years with certain conditions on the basis of the recommendations of the Subject Expert Committee (SEC) on COVID-19.
In the application submitted to the Drugs Controller General of India (DCGI), SII's director (government and regulatory affairs) Prakash Kumar Singh and director Prasad Kulkarni had 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.
"There have been reports of severe disease, including deaths in vulnerable children. 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, thus keeping everyone at risk of severe disease," the company had said in the application.
Considering all these factors, several companies have already started evaluating the safety and immunogenicity of COVID-19 vaccines in the paediatric population, the Pune-based pharmaceutical company had stated.
SII had informed that their collaborator, Novavax Inc. of the US, has already generated a large amount of data in adults in different countries and that the safety, efficacy and immunogenicity data on Novavax are very robust which includes a safety database of more than 50,000 adults from Australia, South Africa, the UK and the USA and preliminary safety data in 2,248 children.
"Further in the ongoing Phase 2/3 study in India, more than 1,400 participants have received at least first dose of the vaccine with no safety concerns reported so far," the application stated.
In August 2020, US-based vaccine maker Novavax Inc had announced a license agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.