Covaxin approved for restricted emergency use in children aged 6-12 years

​ (File image: Vial of Covaxin)

The Drugs Controller General of India (DCGI) has granted restricted emergency-use authorisation to Bharat Biotech's Covaxin for children in the 6 to 12 years age group.

#COVID19 | DCGI (Drugs Controller General of India) gives restricted emergency use authorisation to BharatBiotech's Covaxin for children between the age of 6-12 years: Sources

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— ANI (@ANI) April 26, 2022

The regulator has asked Bharat Biotech to submit safety data, including the data on adverse event with due analysis, every 15 days for the first two months and monthly thereafter up to five months.

The no objection certificate was granted to Bharat Biotech on April 25 after two-month-long deliberations on the recommendation given by the Subject Expert Committee on COVID-19 last week.

The move on the expansion of the Covid-19 vaccine will now depend on the health ministry or the COVID working group of the National Technical Advisory Group on Immunisation.

Also Read: High immune response to COVID variants in breakthrough cases after 2 Covaxin jabs: ICMR study

Corbevax & ZyCoV-D also approved for children in different age groups

The government panel recently recommended approval of Biological E's Covid-19 vaccine Corbevax for use in children in the 5 to 12 years age group.

The DCGI has also recommended the two-dose regimen of ZyCov-D for the age group above 12 years. Last year, Zydus said it was seeking approval from the FDA for a two-dose regimen for ZyCoV-D, which has showed 66.6 percent efficacy in the interim analysis of Phase 3 clinical trials and can be stored for three months at 25 degrees Celsius.

ZyCov-D in August last year got the permission for three-dose vaccine administration in 12+ age group.

ZyCov-D (formerly known as Cadila Healthcare), developed by Gujarat-based Zydus Lifesciences, is touted as the world’s first DNA vaccine. It is administered intradermally using needle-free injection technology (NFIT).

Union Health Minister Mansukh Mandaviya announced on twitter the government's clearance for Covaxin, Corbevax and ZyCov-D jabs for children. All three vaccines are for restricted use in emergency situations, the health minister said.

भारत की कोविड से लड़ाई अब और अधिक मज़बूत @CDSCO_INDIA_INF ने

>6 से <12 आयुवर्ग के लिए 'Covaxin'

>5 से <12 आयुवर्ग के लिए 'Corbevax'

12 से ऊपर के आयुवर्ग के लिए 'ZyCoV-D' की 2 डोज को

'Restricted Use in Emergency Situations' की मंज़ूरी दी है।

— Dr Mansukh Mandaviya (@mansukhmandviya) April 26, 2022

As of now, all above 12 years of age are eligible for COVID vaccination in India but the government has permitted only Corbevax for the 12-14-year age group under the nationwide COVID vaccination programme.

Also Read: New COVID-19 vaccine offers better protection to immunocompromised patients: Study

Bharat Biotech had applied for approval if its vaccine for 2-12-year age group but the Central Drug Standard Control Organisation's SEC had recommended its approval only for 6-12-year age group for now.