The Serum Institute of India (SII) has sought permission from the country’s drug regulator to conduct a phase-3 trial to evaluate the safety and immunogenicity of the Covid-19 vaccine Kovavax as a booster dose for children between the ages of two and 18, official sources said on Sunday.
The Drugs Controller General of India (DCGI) approved in March to conduct Covovax Phase-3 clinical trials as a booster dose among adults.
In an application, Prakash Kumar Singh, SII director of government and regulatory affairs, sought permission to conduct Phase-3, observer-blind, randomized, controlled studies in children between the ages of two and 18 in India who have already received the initial vaccine against COVID. 19 with Covovax at least six months ago.
The study will evaluate the immunogenicity and safety of the vaccine as a booster dose compared to placebo.
Singh said it was clear that immunizations against COVID-19 had dropped after the two-dose schedule and that more than 100 countries had begun administering booster doses.
A total of 408 eligible children between the ages of two and 18 who completed their initial two-dose schedule of Covovax at least six months ago will be enrolled in this study.
Hyderabad-based Bharat Biotech has recently sought permission from the Drug Controller of India to conduct a phase-2/3 study of its covid vaccine Covaxin as a booster dose between the ages of two to 18 years.
Covovax was approved for limited use in adults in emergency situations on 28 December last year and in the 12-17 age group, subject to certain conditions, 9 March.
India has started giving precautionary doses of vaccine to healthcare and frontline workers and those suffering from comorbidities aged 60 years and above from January 10 this year.
The section on intercourse for people over the age of 60 was later removed.
India has started giving precautionary doses of COVID-19 vaccine to all persons above 18 years of age at private vaccination centers from April 10.
Currently everyone over the age of 18 who has completed nine months after taking the second dose is eligible for the precautionary dose.