Panel okays Covaxin emergency use in kids
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Tribune News Service
New Delhi, October 12
The subject expert committee of the national drug regulator on Tuesday cleared Covaxin Covid-19 shot for emergency use in children aged 2 to 18 years, giving India the first approved vaccine for use in kids as small as 2 years. The recommendations have been forwarded to the Drug Controller General of India (DCGI) for final approval.
Previously, the DCGI had cleared Ahmedabad based Zydus Cadila’s ZyCoV-D for emergency use in people aged 12 years and above.
The clearance to Covaxin for children between 2 to 18 years comes at a time when schools are reopening amid fears of the disease impacting children disproportionately.
Although there is no clear evidence of a potential third wave affecting children more, countries have been expanding vaccination drives to cover children with the US and UK taking the lead.
Bharat Biotech had earlier submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to the national regulator.
The regulator’s experts said they had after detailed deliberation recommended the grant of market authorisation of Covaxin for the 2 to 18 years age group for restricted use in emergency situations subject to certain conditions.
The World Health Organization has not yet issued any guidance on Covid vaccine use among children with evidence suggesting a natural immunity among children to viruses. So countries have taken independent calls on the matter.