GS Paper - 2 (Diseases)

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 22 March 2022. 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.

What

  1. SII 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.
  2. The study will evaluate the immunogenicity and safety of the vaccine as a booster dose in comparison with the placebo.
  3. Covovax was approved for restricted use in emergency situations in adults on 28 December last year and in the 12-17 age groups, subject to certain conditions, on 9 March 2022.
  4. 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 2022. The comorbidity clause for people aged above 60 was subsequently removed.
  5. 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.