SII seeks nod for Phase-3 trial of Covovax

May 22, 2022 19:37

Representational image

The Serum Institute of India has sought permission from the country's drug regulator to conduct Phase-3 trial to evaluate the safety and immunogenicity of its COVID-19 vaccine Covovax as a booster dose in children aged two to 18 years, official sources said on Sunday.

The Drugs Controller General of India had granted permission in March for conducting Phase-3 clinical trial of Covovax as a booster dose in adults.

In an application, 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. -- PTI

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