The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday recommended granting permission to the Pune-based pharmaceutical giant Serum Institute of India (SII) for conducting phase 2 and 3 trials of Covovax on children aged 2 to 17 years with certain conditions.
The trial will cover 920 children, 460 each in the age group of 12-17 and 2-11 across 10 sites of the country.
"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (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," PTI reported quoting a source.
SII had submitted a revised protocol for the inclusion of paediatric 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, Prakash Kumar Singh, director (government and regulatory affairs), and Prasad Kulkarni, director, said 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.
"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," they said in the letter.
"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," it added.
SII stated that several companies, after considering all these factors, have already started evaluating the safety and immunogenicity of COVID-19 vaccines in the paediatric population.
"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 letter added. "This will ensure that a life-saving vaccine can be brought at the earliest for our paediatric 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 company statement.
On June 30, SEC had recommended against granting permission to SII for conducting phase 2 and 3 trials of Covovax on children aged 2 to 17 years. SII submitted a revised study protocol last week.
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