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Covaxin has been given emergency usage clearance for children over the age of two; here's what we know
27 Jan' 21

Covaxin has been given emergency usage clearance for children over the age of two; here's what we know

 

Covaxin is safe for children from 2 to 18 years old. 

  • According to sources, Covaxin, India's first wholly indigenous vaccine, has been formally licensed as one of the first COVID-19 vaccinations to be offered for children in India, after authorities granted emergency use authorization. 
  • The vaccine, which was produced by Bharat Biotech in Hyderabad, has been recommended for use in children aged 2 to 18 by The Subject Expert Committee (SEC), a national immunization expert group. The SEC's recommendations have been forwarded to the Drugs Controller General of the United States.
The official statement 
"After extensive debate, the committee recommended the issue of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency circumstance," according to the SEC's official statement.
 
Children's efficacy testing 
In India, an inactive-virus vaccination called Covaxin has been approved for use in adults. While the vaccine is still undergoing further clinical trials, the developers have started their clinical trials at select AIIMS centers across the country to test the efficacy of the vaccine on kids in younger age groups, with a whopping 71 percent efficacy against the SARS-COV-2 virus and its variants. When the vaccine will be ready for use in the pediatrics and adolescent population has yet to be determined.
 
Inoculation guidelines in the event of an emergency 
While the move will bring Indian children on line with children in other nations who prioritize COVID-19 vaccination for children, the SEC recommendation is subject to specific caveats. According to reports, Bharat Biotech would have to meet certain criteria before the vaccine is approved for use: 
"Covaxin's developer will continue the study according to the approved clinical trial protocol for Whole Virion, Inactivated Coronavirus Vaccine." 
Apart from that, for the first two months, the pharma giant will have to list prescribing information, vaccine factsheets, product features, and statistics on AEFI and AESI every 15 days, as required by the FDA.
 
Covaxin nod may aid in the protection of children prior to the third wave. 
The action has been praised as a positive step, given reports that children could be a particularly vulnerable demographic if and when a third COVID wave occurs. 
Apart from Covaxin, ZyCOV-D, a one-of-a-kind DNA COVID-19 vaccine, is also in the works and might be used to immunize younger children first.

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