Bharat Biotech’s Covaxin Gets Emergency Approval For Children Aged 2-18 yrs, DCGI Yet To Give Final Nod

Two doses of Covaxin are likely to be administered to children with a gap of 28 days. For adults, the government has set a gap of 4-6 weeks between the two shots.

Written by: India.com News Desk Edited by: Analiza Pathak

Updated: October 12, 2021, 6:08 PM IST

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https://www.india.com/news/india/breaking-bharat-biotech-covaxin-gets-dcgi-emergency-approval-for-children-aged-2-18-years-5051006/ Copy

Covaxin approved for children between 2-18

New Delhi: The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group. The Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and had submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of this month.

With this, Covaxin becomes the first COVID-19 vaccine that can be administered to children in India.

However, hours after expert panel recommendation, Dr Bharati Pravin Pawar clarified that the evaluation is still going on. She added, “There is some confusion & the talks are underway with the experts’ committee. Till now Drugs Controller General of India (DCGI) hasn’t approved it.”

The evaluation is still going on. There is some confusion & the talks are underway with the experts' committee. Till now Drugs Controller General of India (DCGI) hasn't approved it: MoS Health, Dr Bharati Pravin Pawar on approval to Covaxin for 2-18 years age group pic.twitter.com/OKb3AJDaOQ

— ANI (@ANI) October 12, 2021

While BB’s vaccine Covaxin has been approved for adults for over a year, separate trials were needed to be done to ensure the vaccine is also safe for children. Two doses of Covaxin are likely to be administered to children with a gap of 28 days. For adults, the government has set a gap of 4-6 weeks between the two shots.

The drug regulator said, “After detailed deliberation, the committee recommended for grant of market authorization” to children in age group of 2-18 years.

The DGCI added, “The emergency use authorisation, however, is subject to certain conditions. The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.”

The approval, however comes with four conditions.

• The firm should continue the study as per the approved clinical trial protocol;
• The firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet.
• The firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials Rules, 2019.
• The firm should submit risk management plan. Further all other conditions of the earlier approval in the age group of ≥ 18 years shall remain same, news18.com reported.

India is turning its focus towards vaccinating children against the coronavirus, having already administered nearly 96 crore doses to adults.

Dr Randeep Guleria, chief of Delhi’s AIIMS, had earlier said children will also have to get vaccinated “to get rid of the pandemic”.

Earlier this month Dr NK Arora, the chief of India’s vaccine task force, told news agency ANI children with severe comorbidities would be prioritised and that other kids would be immunised subsequently.

“We are trying to identify (children) at highest risk… within the next couple of weeks, the list will be in the public domain. We are also making arrangements so these children do not have to travel (too far) to get the vaccine…” he said.

Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin. Bharat Biotech had reportedly submitted all documents required for the listing to the WHO by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.