Bharat Biotech’s Covid-19 vaccine, Covaxin, on October 12, has been approved for emergency use among children between 2 and 18 years of age by an expert panel.
The Hyderabad-based drugs regulator has submitted data from clinical trials in the 2-18 age group for Covaxin to Central Drugs Standard Control Organisation (CDSCO). The data was thoroughly reviewed by the Subject Expert Committee (SEC), and then it provided positive recommendations.
The company said this represents one of the first approvals globally for Covid-19 vaccines for the 2-18 age group. “We now await further regulatory approvals before product launch and market availability of Covaxin for children,” Bharat Biotech said in a statement.
The same formula of Covaxin that was used on adults has been tested on children. However, separate trials were required to guarantee safety and efficacy on younger recipients. Last week, Bharat Biotech said that it had submitted data on vaccine trials on children.
Data on these trials have not been made public yet. However, tests were conducted on over 1000 children across India. The panel noted that the trial on kids showed similar efficacy rates as that on adults.
The Drug Controller General of India’s final approval for emergency use approval is yet to be given.
Covaxin is the second Covid-19 vaccine after Zydus Healthcare’s ZyCoV-D (meant for children above 12 years of age) to be approved for emergency use among children in India.
Last month, the DCGI had cleared trials of Serum Institute’s Novavax for children between 7 years and 11 years. Other than Covaxin, ZyCoV-D and Novavax, a fourth potential vaccine for kids is Biological E’s Corbevax that has been cleared to conduct advanced trials on children above 5 years of age.
India has administered around 96 crore doses to adults and is gradually turning its focus towards vaccinating children against the coronavirus, with schools reopening and students returning to classrooms.
