New Delhi: Panel Expert Narcotics Authorities of the Central State on Wednesday was recommended to give permission to the Indian Serum Institute (SII) to conduct a phase 2/3 Covid-19 trial vaccine Covovax in children aged two to 17 years, said source.
SII is applied to the drug controller General India (DCGI) on Monday seeking permission to conduct Covovax trials at 920 children, each 460 in the age group 12-17 and 2-11, at 10 sites.
“The Subject Expert Committee (SEC) on the Covid-19 Standard Control Organization Center (CDSCO), which was notified on the application, noted that the vaccine has not been approved in any country,” said a source.
“It also recommends that Pune-based companies have to submit the safety and immunogenicity data (from Covovax) from the ongoing clinical trials in adults to consider clinical trial behavior in children,” said the source.
The recommendation was studied for approval by DCGI.
On August 2020, a vaccine maker based in US Novavax Inc.
Has announced the license agreement with the SII for the development and commercialization of the NVX-COV2373, Covid-19 vaccine candidate, in low and medium and independent income countries.
The Covovax clinical trial began in India in March and SII hoped to launch it in September for adults.
In January, SII has launched a covishield vaccine in this country.
It has entered collaboration with the University of Oxford and Astrazeneca to produce vaccines.
The GOVT panel recommends that it does not allow SII to conduct Covovax trials in children aged 2-17 years
