03 Oct 2021: COVAXIN trial data for children aged 2-18 submitted to DCGI
Bharat Biotech has reportedly submitted trial data of its COVID-19 vaccine, COVAXIN, for children aged under 18 years to the Drugs and Comptroller General of India (DCGI). The company reportedly completed Phase-II and Phase-III vaccine trials on children aged 2-18 years in September. This comes amid reports that COVAXIN is likely to get World Health Organization's emergency use approval this month.
Details: India has approved only 1 vaccine for children so far
Children are not included in the COVID-19 vaccination drive in India as yet. Of the six vaccines that have received emergency use approval from the DGCI, only one, ZyCoV-D, has received the nod for being administered to children, aged between 12-18 years. It is yet to be rolled out. If approved, COVAXIN will be the second vaccine to be approved in India for kids.
WHO: COVAXIN still awaits WHO's nod
Separately, Bharat Biotech has not yet received emergency use approval from the WHO for COVAXIN. The company had reportedly submitted all documents required for clearance by July 9. The WHO's review process, which usually takes six weeks, had started by July-end. Due to this non-approval from the WHO, people inoculated with COVAXIN are considered non-vaccinated abroad and required to undergo mandatory quarantine.
Fact: 'I don't know why countries are indulging in such nationalism'
Criticizing the mandatory quarantine for those vaccinated with COVAXIN, Bharat Biotech's Chairperson Dr. Krishna Ella told India Today, "I don't know why countries are indulging in such nationalism." He, however, refused to comment on the recent row with the United Kingdom on the same issue.
WHO: No comment on timeline of WHO clearance
On the WHO's emergency clearance, Dr. Ella said they submitted all the data to the agency and have done the requisite work. "Bharat Biotech has received past approval for other vaccines and is used to the approval process," he said, not commenting on a timeline for the clearance. He further said that Bharat Biotech is looking at the nasal vaccine as a booster shot.
Children: Demands to vaccinate children increasing as schools start reopening
The calls to inoculate children have been gaining ground in India as schools are reopening across many states. Fears over an imminent third wave of infections have also added to those calls as many believe the lack of vaccinations among children will leave them unprotected. However, some experts believe there is little to worry about as children are less prone to severe infections.
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Also see: Expert panel recommends emergency use authorization for Zydus's three-dose vaccine
Government expert panel recommends conducting trials on mixing Covishield, COVAXIN
Expert panel says no to Covovax's children trials in India
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