New Delhi: Volunteer Recruitment for clinical trial Phase 2/3 of Covid-19 Covovax Vaccines among children aged 2 to 17 years begin on Sunday at the Hamdard Institute of Medical Sciences and Research here.
The trial will be held at 10 sites and will cover 920 children – 460 each in the age group 12-17 and 2-11 – according to official sources.
Zydus Covid-19 vaccine developed by Zydus Cadila Zycov-D has received an emergency use authorization from the drug regulator, making it the first vaccine given to the 12-18 year age group in the country.
Indian drug regulators in July have given permission to the Serum Institute of India (SII) to conduct a 2/3 Covovax phase test in children aged 2 to 17 years with certain conditions based on the recommendation of the Subject Expert Committee (SEC) on Covid-19.
In the application submitted to the drug controller General India (DCGI), Director of SII (Government and Regulation Affairs) Prakash Kumar Singh and Director of Prasad Kulkarni has stated that globally, all adults aged 18 years and over are vaccinated and after this population is protected against Covid-L9, children will remain the most vulnerable group.
“There are severe disease reports, including death in vulnerable children.
It has also been predicted that the third wave of pandemics can affect children in this country.” Moreover, until all age groups, including children, are covered under vaccination.
The SARS-COV-2 virus can remain outstanding, so keep everyone at risk of experiencing severe disease, “said the company in the application.
Considering all these factors, some companies have begun to evaluate the safety and immunogenicity of the Covid-19 vaccine in the child’s population, Pune-based pharmaceutical companies Has said From Australia, South Africa, Britain and the US and initial safety data in 2,248 Childre N.
“Furthermore in the ongoing phase 2/3 study in India, more than 1,400 participants have received at least the first dose of vaccines without security problems reporting so far, “Application said.
On August 2020, US-based vaccine maker Novavax Inc.
had flopped Mkan license agreement with SII for the development and commercialization of NVX-COV2373, Covid-19 vaccine candidates, in low and medium and medium and india-income countries.