The Hyderabad-based pharma major Bharat Biotech’s Covaxin has got the emergency use approval for children in the age group of 2 to 18 years from the Drugs Controller General of India (DCGA). The Subject Expert Committee on Covid-19 gave the approval for the emergency use in the children.Also Read - Indians Eagerly Await WHO Approval For Homegrown Covid Shot 'Covaxin' to Travel Abroad
“After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” the expert panel said in a statement. Also Read - Bharat Biotech's Covaxin Likely To Get Approval For Emergency Use Within 24 hours, Says WHO Official
We reached out to Dr Kanchan Channawar, Consultant Pediatrician, Kamineni Hospitals to understand if Covaxin is safe for the kids or not. She explained, “Covaxin is an inactivated killed vaccine which is made by a conventional method same as other vaccines we are using from decades like DPT polio Flu. It has proven very effective in the adult population without significant side effects so hopefully, it will have a similar effect in the pediatric population from above 2 years. It will not only give the protection but also help to restore the faith among parents to send their kids to school.” Also Read - Dangers of Ignoring Your Back Pain And Spine Problems
How many doses to take?
Bharat Biotech had submitted the trial data of phase 2 and 3 of Covaxin on children at the beginning of this month to the apex body — DCGI at the start of this month. The vaccine will be administered in two doses with 20 days of interval.
However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.
Dr Kanchan says, “The regular two doses are enough as of now. As the strain is milder as compared with the earlier variants.”
Will the kids need a booster dose?
According to Dr Kanchan, kids requiring booster dose will be once confirmed with time. But as of now two doses of the vaccine would suffice and protect from the virus
In regard to restricted usage. “It is not a regular vaccination. It is due to the pandemic that it has become vital. Hence, we need to see that there is a restricted usage that is only in an emergency,” Dr Kanchan concluded.
Remarkably, the global health body World Health Organisation has not granted the emergency use authorisation to Covaxin. The World Health Organisation said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much-awaited EUL to Covid vaccine Covaxin.
The WHO said in the last meeting, “WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin”.