<p>The Serum Institute of India (SII) 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.</p>.<p>The Drugs Controller General of India (DCGI) had granted permission in March for conducting Phase-3 clinical trial of Covovax as a booster dose in adults.</p>.<p>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.</p>.<p>The study will evaluate the immunogenicity and safety of the vaccine as a booster dose in comparison with the placebo.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.<p>Covovax was approved for restricted use in emergency situations in adults on December 28 last year and in the 12-17 age group, subject to certain conditions, on March 9.</p>.<p>India began administering precaution doses of the vaccines to the healthcare and frontline workers and those aged 60 and above with comorbidities from January 10 this year.</p>.<p>The comorbidity clause for people aged above 60 was subsequently removed.</p>.<p>India began administering precaution doses of Covid-19 vaccines to all aged above 18 years at private vaccination centres from April 10.</p>.<p>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.</p>
<p>The Serum Institute of India (SII) 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.</p>.<p>The Drugs Controller General of India (DCGI) had granted permission in March for conducting Phase-3 clinical trial of Covovax as a booster dose in adults.</p>.<p>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.</p>.<p>The study will evaluate the immunogenicity and safety of the vaccine as a booster dose in comparison with the placebo.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.<p>Covovax was approved for restricted use in emergency situations in adults on December 28 last year and in the 12-17 age group, subject to certain conditions, on March 9.</p>.<p>India began administering precaution doses of the vaccines to the healthcare and frontline workers and those aged 60 and above with comorbidities from January 10 this year.</p>.<p>The comorbidity clause for people aged above 60 was subsequently removed.</p>.<p>India began administering precaution doses of Covid-19 vaccines to all aged above 18 years at private vaccination centres from April 10.</p>.<p>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.</p>