Chandigarh: Not a bad event has been reported in the Covovax trial conducted in PGI in children aged between 12 and 17 years.
Furthermore, in line is a trial in children in the age group of two to six years.
Safety data must be approved by the Indian Narcotics Controller (DGCI) to start the trial.
There are a total of 128 children in this group on all sites.
“There are no bad events for 12 years and 17 groups of groups on our site,” said Prof.
Madhu Gupta, the main investigator for the study at PGI.
PGI is one of the trial centers for Covovax, which will become a 2/3 phase of randomized random control study observers to determine the safety and immunogenicity of Covovax in children between two and 17 years old.
This study, sponsored by the Indian Serum Institute (SII), will have 100 participants.
Children will be followed up for six months after being given two Covovax shots after a gap of 21 days.
SII has partnered with Novovax, which has been labeled as Covovax in India.
There is no nose vaccine court for children being carried out in this country.
However, the Zycov-D vaccine has received approval for limited use in emergency arrangements by national regulators – DCGI for 12 years and above age groups, based on clinical data while phase III clinical trials are carried out in the country.
Clinical Clinical Test Data Phase II / III Interim from Covaxin in healthy volunteers aged two to 18 years delivered by Bharat Biotech intentional at the Subject Expert Committee meeting.
The Committee recommends market authorization grants for the age group of two to 18 years for limited use in emergency situations with various conditions.
This recommendation is being checked and additional information has been requested at the Central Medicine Standard Control Organization level (CDSCO).