The Subject Expert Committee (SEC) granted an Emergency Use Authorization(EUA) to Bharat Biotech’s Covaxin for kids of age group 2 to 18 on Tuesday.
The committee cleared its recommendation to the Drugs Controller General of India (DCGI) for the final green flag. Once approved by DCGI, it will become the first vaccine to be administered to children in India.
The expert panel recommended the grant of market authorization of Cavaxin for restricted emergency use in children aged 2 and above.
Bharat Biotech in a statement expressed its appreciation to the Subjects Expert Committee (SEC) and Central Drugs Standard Control Organisation (CDSCO) for facilitating the review process. Positive recommendations followed thorough reviews.
Indigeniously developed Covaxin is just a step away from vaccinating kids
In an earlier development, Bharat Biotech submitted data from phase 2 and phase 3 clinical trials of children’s trials to DCGI for verification and approval for emergency use authorization (EUA) for Covaxin shots..
Bharat Biotech is now looking forward to regulatory approvals from the CDSCO prior to product launch and Covaxin’s market availability for Children.
The vaccine will be administered to children via two jabs with a gap of 28 days. Whereas For adults a gap of 4-6 weeks between both the doses is followed.
Homegrown vaccine Covaxin developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) is already a major part of India’s ongoing vaccination drive for adults. India has vaccinated around 30 crore people out of its 130 crore population till now.
Covaxin’s efficacy among children is similar to that in adults. As per the phase 3 clinical trials data in adults, its efficacy was 77.8%.
The vaccine developer claims Covaxin has become one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.
Covaxin is the second COVID-19 vaccine to get an emergency use nod for children. Zydus Healthcare’s CyCoV-D in August received approval from DGCI meant for children above the age of 12.
Emergency use approved under these 4 conditions
The SEC subjected emergence use authorization to broadly four conditions.
Bharat Biotech will sustain the study as per the provision of Whole Virion, under the approved clinical trial protocol inactivated coronavirus vaccine.
The vaccine developer will also have to provide Information/ Package(PI), Summary of Product Characteristics (SmPC) along with Factsheet
Furthermore, the company should provide safety data including the data on AEFI and AESI with due analysis. Every 15 days for the first two months and on a monthly basis following that. Under the provisions of New Drugs & Clinical Trials Rules, 2019.
A ray of hope in our fight against the pandemic
The vaccine is safe and provides the required efficacy against the virus. This development is a huge relief for parents as students are returning to school. Covaxin will provide a layer of protection against COVID-19 for kids.
India is looking forward to pacing up vaccination for children. However, the government is yet to decide on its inclusion in India’s vaccination programme.
This week WHO will consider granting Emergency Use Authorisation to Covaxin. WHO has commenced its review process, therefore, experts will conduct the risk-benefit assessment before making the final decision.
Emergency Use Authorisation by WHO, once granted will change the perception of Covaxin by countries across the world. It will help lower the hesitancy and allow Indians to travel without undertaking quarantine measures.