Covaxin gets emergency-use approval for 2-18 age group

New Delhi, Oct 12: 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.
The expert panel said in a statement, “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 emergency situation.”
Bharat Biotech had submitted the trial data of phase 2 and 3 of Covaxin on children in 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.
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”.
Doctors welcome move
Doctors welcomed the recommendation of an expert panel to grant emergency use authorisation to Bharat Biotech’s Covaxin for children with certain conditions, but flagged the fact that the anti-COVID-19 vaccine has still not been accepted globally.
Efforts must be made to establish its efficacy globally so that the children are not subject to restrictive measures when they travel abroad, they said.
An expert panel of India’s central drug authority has recommended granting emergency use authorisation to Covaxin for children in the age group of two to 18 years with certain conditions, sources said on Tuesday. “It will be beneficial both for the children as well as those around them. We need to achieve herd immunity and decrease the risk of further waves. No doubt that children and adolescents are vulnerable groups and if the vaccine safety data is strong enough and we immunise them, it will have a big impact in reducing the transmission of Covid,” said Dr Akshay Budhraja, senior consultant, pulmonology, Aakash Healthcare, Dwarka.
He added that this will prove to be a major step as schools, coaching centres and sports centres are gradually opening.
Calling it a step towards defeating the pandemic, Dr Gauri Agarwal, founder, Seeds of Innocence, said it will help children resume their normal lives again. “However, according to the principal investigator of Covaxin trials on children, the vaccine safety and immunogenicity results are awaited. It is important to establish the efficacy of the vaccine by the time it is approved for administration,” she said.
At the same time, efforts must be made to establish the efficacy of the vaccine globally so that the children are not subject to restrictive measures when they travel abroad, she added. (Agencies)

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