Bharat Biotech’s Covaxin has been given emergency use approval by the Covid-19 Subject Expert Committee for children aged 2 to 18.
According to persons familiar with the situation, the national medicines regulator’s topic expert committee approved the use of Bharat Biotech’s Covaxins as a layer of protection against coronavirus or Covid-19 disease in children aged 2 to 18. Covaxin’s efficacy in children was found to be similar to that in adults, according to an official, but no decision on its inclusion in the national immunisation programme had yet been made.
After Zydus Healthcare’s ZyCoV-D, which is intended for children over the age of 12, Covaxin is the second Covid-19 vaccine to be licenced for emergency use among children in India.
Statement Issued on Covaxin
The business said it had submitted data from clinical studies in the 2-18 age category to the CDSCO in a statement released on Tuesday. After a thorough assessment by the SEC, the positive suggestions were forwarded to India’s Drugs Controller General (DCGI).
According to a top Central Government official, Bharat Biotech, based in Hyderabad, completed Phase 2 and Phase 3 trials of Covaxin on children under the age of 18 in September and submitted the trial results. The trials were conducted on children aged 2 to 6, 6 to 12, and 12 to 18 years old.
If introduced, the vaccination is likely to happen through pre-filled syringes for better dose accuracy, he added.
According to scientists involved in the clinical trials, Covaxin’s safety and efficacy in the paediatric age group was found to be essentially identical to that in adults, with a success rate of 77.8%, according to data from phase 3 clinical trials on adults.
“Data from COVAXIN clinical trials involving children aged 2 to 18 years has been submitted to the Central Drugs Standard Control Organization” (CDSCO). COVAXIN is the first Covid-19 vaccine that has been tested in children aged 2 to 6. This was made possible by the manufacturing platform’s safety and empirical evidence from adult phase I, II, and III clinical trials,” India’s vaccine giant said in a statement.
The World Health Organization is likely to make a decision shortly on Bharat Biotech’s application for an Emergency Use Listing (EUL) for Covaxin.
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