Covaxin – Bharat Biotech’s COVID-19 vaccine has been reccomended – for use on children between the ages of two and 18 by an expert panel
“Bharat Biotech has submitted data from clinical trials in the two – 18 age group for Covaxin to CDSCO (Central Drugs Standard Control Organisation). The data has been thoroughly reviewed by the Subject Expert Committee (SEC)… provided positive recommendations,” the Hyderabad-based company said according to NDTV.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the two – 18 age group… We now await further regulatory approvals prior to product launch and market availability of Covaxin for Children,” the company said.
“We (always) said we will get a vaccine for children between two and 18… it will be approved soon. SEC has recommended… it will be approved soon… trials were conducted keeping in mind safety of children. We are committed to their safety,” junior Health Minister Dr Bharti Pravin Pawar told NDTV.
That final approval – viewed as a formality – will be given by the Drug Controller General of India.
When it does come, Covaxin will be only the second vaccine cleared for use on kids in India; in August Zydus Cadila’s three-dose DNA jab was allowed to be used on adults and children over 12.
A third potential vaccine for kids is Serum Institute’s Novavax, for which the DCGI last month cleared trials for children between seven and 11 years. A fourth is Biological E’s Corbevax, which has been cleared to conduct advanced trials on children above five.
Last week manufacturers Bharat Biotech said it had submitted data on vaccine trials on children.
The Covaxin vaccine tested on children is the same formulation as used on adults, but separate trials were needed to guarantee safety and efficacy on younger recipients.
Data on these trials has not been made public yet, but tests were conducted on 1,000+ children across the country. The panel, however, noted the trial on kids showed similar efficacy rates as that on adults.
Data on the vaccine’s efficacy (for adults) was submitted to the DCGI in June; the data indicated Covaxin is 77.8 per cent effective in protecting against the virus.