The Serum Institute of India (SII) has sought permission from the nation’s drug regulator to conduct Phase-3 trial to guage the protection and immunogenicity of its COVID-19 vaccine Covovax as a booster dose in youngsters aged two to 18 years, official sources stated on Sunday.
The Drugs Controller General of India (DCGI) had granted permission in March for conducting Phase-3 scientific trial of Covovax as a booster dose in adults.
In an utility, SII Director for Government and Regulatory Affairs Prakash Kumar Singh has sought permission to conduct the Phase-3, observer-blinded, randomised, managed examine in youngsters aged two to 18 years in India who’ve already obtained major vaccination in opposition to COVID-19 with Covovax at the very least six months in the past.
The examine will consider the immunogenicity and security of the vaccine as a booster dose as compared with the placebo.
Singh is learnt to have acknowledged that it has turn into evident that the safety supplied in opposition to COVID-19 wanes after a two-dose schedule of vaccines and that greater than 100 international locations have began administering booster doses.
A complete of 408 eligible youngsters of two to 18 years of age who’ve accomplished the first two-dose schedule of Covovax at the very least six months in the past will likely be enrolled within the examine.
The Hyderabad-based Bharat Biotech has lately sought permission from India’s drug regulator to conduct Phase-2/3 examine of its Covid vaccine Covaxin as a booster dose amongst these aged two to 18 years.
Covovax was accredited for restricted use in emergency conditions in adults on December 28 final 12 months and within the 12-17 age group, topic to sure circumstances, on March 9.
India started administering precaution doses of the vaccines to the healthcare and frontline employees and people aged 60 and above with comorbidities from January 10 this 12 months.
The comorbidity clause for individuals aged above 60 was subsequently eliminated.
India started administering precaution doses of COVID-19 vaccines to all aged above 18 years at personal vaccination centres from April 10.
Currently all these above the age of 18 who’ve accomplished 9 months after the administration of the second dose are eligible for the precaution dose.
Source: www.financialexpress.com”