The Drug Controller General of India (DCGI) on Tuesday granted emergency use approval to Covid-19 vaccines, Covaxin and Corbevax, for children below 12, official sources said on Tuesday. Bharat Biotech’s Covaxin has got the nod for use in children in the age group of 6-12, while Biological E’s Corbevax can be administered to children aged 5-12. The apex drug regulator also gave nod to pharma major Zydus Cadila’s ZyCov-D vaccine for use in children above 12 years for a two-dose regimen, said Zydus Lifesciences Ltd., the pharmaceutical company. With this approval, the vaccine will now be administered on day 0 and day 28. Earlier, the vaccine was approved in a three-dose regimen to be administered on day 0, day 28 and day 56. Speaking on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences said, “The approval of a two-dose regimen for ZyCoV-D is a welcome development. This will increase the compliance with the vaccine and reduce the overall time required for vaccination to improve immunity against the virus. It will also help in administering the vaccine to a larger population in a shorter time which is always desirable in the midst of a pandemic.” The two-dose regimen for ZyCoV-D was tested in 3,100 healthy volunteers more than 12 years of age.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation. The SEC had last week reviewed the application of both the companies seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years and six to 12 years age group, respectively. Biological E’s Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years. Covaxin has been granted Emergency Use Listing by the DCGI for the age group of 12 to 18 years on 24 December 2021.
India began inoculating children aged 12-14 on 16 March. The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year. The next phase of Covid-19 vaccination commenced on 1 March last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditions. India launched vaccination for all people aged more than 45 years from 1 April last year. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from 1 May last year.
Meanwhile, India recorded 2,483 new Covid-19 in the last 24 hours, recording a slight decline from the previous day’s 2541 cases. The active caseload has also dipped from 16,522 to 15,636, while the positivity rate declined to 0.55 per cent, according to the Ministry of Health and Family Welfare bulletin on Tuesday. A total of 1,970 Covid-19 patients recovered from the disease in the last 24 hours, taking the total number of recoveries since the beginning of the pandemic to 4,25,23,311. The recovery rate is 98.75%. As a total of 4,49,197 Covid-19 tests were conducted in the last 24 hours, the cumulative tally has risen to 83.54 crore tests. The country reported 1,399 Covid-19 related deaths in the last 24 hours; 1,347 deaths have been counted from Assam which includes Covid-19 patients who died due to other reasons. However, it added, that the state has reported zero deaths in the last 24 hours.