Form of words:
New Delhi: The recruitment of volunteers for the Phase 2/3 clinical trial of COVID-19 vaccine Covovax among children aged 2 to 17 years at Hamdard Institute of Medical Sciences and Research here began on Sunday.
According to official sources, the test will be conducted at 10 sites and will involve 920 children, each in the age group of 12-17 and 2-11, with 460 children.
Indigenously developed Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has received emergency use authorization from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.
In July, India’s drug regulator allowed the Serum Institute of India (SII) to conduct Phase II trials of Kovovax on children aged 2 to 17 years, based on the recommendations of the Subject Expert Committee (SEC), with certain conditions. . COVID-19.
In an application submitted to the Drug Controller General of India (DCGI), SII Director (Government and Regulatory Affairs) Prakash Kumar Singh and Director Prasad Kulkarni had said that globally, all adults aged 18 years and above are being vaccinated. and after that the population is protected. Against COVID-l9, children will remain a susceptible group.
“There have been reports of serious illness including deaths among vulnerable children. It is also predicted that a third wave of the pandemic could affect children in the country.
“Furthermore, unless all age groups, including children, are covered under vaccination, the SARS-CoV-2 virus may remain in circulation, thus putting everyone at risk of serious illness,” the company said. Said in the application.
Considering all these factors, several companies have started evaluating the safety and immunogenicity of COVID-19 vaccines in the pediatric population, the Pune-based pharmaceutical company had said.
SII had informed that their partner, Novavax Inc. of the US. has already generated a large amount of data in adults in various countries and the safety, efficacy and immunosuppression data on Novavax is very robust with a safety database of over 50,000. Preliminary safety data in adults and 2,248 children from Australia, South Africa, UK and USA.
“In the ongoing Phase 2/3 study in India, more than 1,400 participants received at least the first dose of the vaccine, with no safety concerns so far,” the application said.
In August 2020, US-based vaccine maker Novavax Inc. had announced a license agreement with SII to develop and commercialize its COVID-19 vaccine candidate NVX-CoV2373 in low- and middle-income countries and India.
Read also: First batch of Covaxin released from Bharat Biotech’s new plant in Gujarat
subscribe our channel youtube And Wire
Why is the news media in crisis and how can you fix it?
India needs free, unbiased, non-hyphenated and questionable journalism even more as it is facing many crises.
But the news media itself is in trouble. There have been brutal layoffs and pay-cuts. The best of journalism are shrinking, yielding to raw prime-time spectacle.
ThePrint has the best young journalists, columnists and editors to work for it. Smart and thinking people like you will have to pay the price for maintaining this quality of journalism. Whether you live in India or abroad, you can Here.