OPEN APP
Home / News / India /  SII seeks phase-3 trial permission for Covovax as booster dose for 2-18 years. Read here

SII seeks phase-3 trial permission for Covovax as booster dose for 2-18 years. Read here

Serum Institute of India (SII) has now sought permission to conduct Phase-3 trials to evaluate the safety and immunogenicity of Covovax as a booster dose in children aged two to 18 years (Adar Poonawalla Twitter)Premium
Serum Institute of India (SII) has now sought permission to conduct Phase-3 trials to evaluate the safety and immunogenicity of Covovax as a booster dose in children aged two to 18 years (Adar Poonawalla Twitter)

The study will evaluate the immunogenicity and safety of the vaccine as a booster dose in comparison with the placebo.

Listen to this article

NEW DELHI : After getting permission for for conducting Phase-3 clinical trial of Covid-19 vaccine Covovax as a booster dose in adults, the Serum Institute of India (SII) has now sought permission to conduct Phase-3 trials to evaluate the safety and immunogenicity of Covovax as a booster dose in children aged two to 18 years.

SII Director for Government and Regulatory Affairs Prakash Kumar Singh has sought permission to conduct the Phase-3, observer-blinded, randomised, controlled study in children aged two to 18 years in India who have already received primary vaccination 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 in comparison with the placebo.

Singh is learnt to have stated that it has become evident that the protection offered against Covid-19 wanes after a two-dose schedule of vaccines and that more than 100 countries have started administering booster doses.

A total of 408 eligible children of two to 18 years of age who have completed the primary two-dose schedule of Covovax at least six months ago will be enrolled in the study.

The Hyderabad-based Bharat Biotech has recently sought permission from India's drug regulator to conduct Phase-2/3 study of its Covid vaccine Covaxin as a booster dose among those aged two to 18 years.

Covovax was approved for restricted use in emergency situations in adults on 28 December last year and in the 12-17 age group, subject to certain conditions, on 9 March.

India began administering precaution doses of the vaccines to the healthcare and frontline workers and those aged 60 and above with comorbidities from 10 January this year.

The comorbidity clause for people aged above 60 was subsequently removed.

India began administering precaution doses of Covid-19 vaccines to all aged above 18 years at private vaccination centres from 10 April.

Currently all those above the age of 18 who have completed nine months after the administration of the second dose are eligible for the precaution dose. 

Subscribe to Mint Newsletters
* Enter a valid email
* Thank you for subscribing to our newsletter.
Close
Recommended For You
×
Edit Profile
Get alerts on WhatsApp
Set Preferences My ReadsFeedbackRedeem a Gift CardLogout