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 (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated on the revised study protocol application given by SII on Tuesday and recommended granting permission to the firm for conducting phase 2/3 trial of Covovax on children aged 2 to 17 years,” a source said.
The Pune-based pharmaceutical company had submitted a revised protocol for 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.
In the revised application submitted last week, SII director (government and regulatory affairs) Prakash Kumar Singh and director Dr Prasad Kulkarni 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,” they said in the letter.
Considering all these factors, several companies have already started evaluating the safety and immunogenicity of COVID-19 vaccines in the pediatric population, the SII has stated.
The SII is learnt to have informed that their collaborator, Novavax, Inc., US has already generated a large amount of data in adults in different countries and that the safety, efficacy and immunogenicity data on the Novavax COVID-I9 vaccine are very robust which includes a safety database of more than 50000 adults with data from Australia, South Africa, UK and USA and preliminary safety data in 2248 children.
“Further 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,” the application stated.
“This will ensure that a life saving vaccine can be brought at the earliest for our pediatric population also in addition to the adult population immediately after grant of Emergency Use Authorisation.
“This approval will ensure an early availability of COVID-19 vaccine for children of our country in line with our prime minister’s clarion call Atmanirbhar Bharat and will help in faster elimination of the COVID-19 pandemic,” Singh mentioned in the application
The SEC on June 30 had recommended against granting permission to SII for conducting phase 2 and 3 trial of Covovax on children aged 2 to 17 years following which the company had submitted a revised study protocol last week.
In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.