Bharat Biotech’s Covaxin has been approved for marketing subject to certain conditions. However, this does not mean that the vaccine can be brought for emergency use. A final decision is yet to be taken on whether to give this vaccine to children and adolescents aged 2 to 18 years. According to government sources, it will take a few days to verify the data provided by the company. If all goes well, Covaxin will be approved for emergency use in age groups 2-18 by the drug regulator.
The National Technical Advisory Committee on Immunization (NTA-GI) formed after approval by the Drugs Controller General of India (NTA-GI) will also examine the data. Once it is flagged off, Covaxin will be made part of the children’s immunization programme.
What will happen before the final approval?
Bharat Biotech must submit updated prescribing information, package inserts, a summary of product characteristics, and fact sheets. Apart from this, a detailed plan will have to be given for risk management. After approval, the company will have to report adverse effects every 15 days for the first two months, and every month thereafter. The National Technical Advisory Committee on Immunization, after examining the data, will approve it for inclusion in the national program.
What vaccines do we have for children here?
Approval has been given for use on people 12 years of age or older. However, it is not yet included in the vaccination program.
Covaxin (Bharat Biotech)
Approved for use on those 2 years of age or older. This vaccine is also not part of the vaccination programme.
Corbevax (Biologicals E)
Trial approval in children 5 to 18 years of age.
Covavax (Serum Institute of India)
Approved for trial in children 2 to 18 years.
Covaxin is as effective on children as in adults
In trials on children, Covaxin has shown the same effect as adults. Its safety and immune response have been the same. Yes, its Phase 3 data has not yet been peer-reviewed, about which some experts have expressed concern. Covaxin has not yet been approved by the World Health Organization. Even after the vaccine is approved, it can be made available in a phased manner. First, the vaccine can be given to children with co-morbidities.
Covaxin to get EUA soon
Unlike Covaxin, ZyCov-D by Zydus Cadila is approved for emergency use in children over 12 years of age. Serum Institute of India is conducting Phase 2 and 3 trials of Covavax on children aged 7 to 11 years. Covaxin may soon get approval for emergency use.
A Mumbai-based analyst said, “It is estimated that 350-400 million people in India are below the age of 18 years. A two-dose Covid vaccine regimen would translate into 700-800 million doses of potential demand.”
Bharat Biotech has struggled to keep pace with demand for its Covid-19 shots. The company has indicated it would make 55 million doses in October and is aiming to touch 80 million doses a month by December.
As of now, the other vaccines approved for children so far are for use in three years and above.
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