New Delhi: In a significant boost to India’s fight against COVID-19, the Subject Expert Committee (SEC) has recommended to the Drugs Controller General of India (DCGI) the use of Bharat Biotech’s Covaxin for children aged 2 to 18, according to ANI on Tuesday (October 12, 2021). Covaxin, in particular, will now be the country’s first COVID-19 vaccine that can be given to children.
However, an official response is still pending.
The news comes nearly a week after sources claimed that Bharat Biotech, which completed the Phase 2/3 trials of Covaxin for use in children under the age of 18, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for verification and subsequent approval for the jab’s Emergency Use Authorisation.
“Covaxin clinical trial data of 2-18 years age group has been submitted to CDSCO… This is feasible due to the safety of the manufacturing platform and empirical evidence from Phase 1,2 and 3 clinical trials in adults,” sources told the PTI news agency.
According to an AIIMS professor, the latest trials show that the safety and immunogenicity of Covaxin are nearly the same in children as in adults over the age of 18. According to Dr. Sanjay K Rai, a professor at AIIMS’s Centre for Community Medicine, Covaxin’s trial was conducted on three age groups.
“The first group examined was between the ages of 12 and 18 years,” he explained. “The second group was between the ages of 6 and 12 years, and the third age group was between the ages of 2 and 6 years.”
We began by completing the examination of people aged 12 to 18 years old, and then moved on to other age groups. The vaccine safety and immunogenicity of Covaxin are nearly identical. The final results of these trials, however, are still awaited,” he added.
The World Health Organization (WHO) is also expected to grant Covaxin’s long-awaited emergency use authorization this week. The global health body and an independent group of experts are set to meet this week to conduct the risk/benefit analysis and make a final decision on whether to grant Covaxin Emergency Use Listing.
It should be noted that Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology by Hyderabad-based Bharat Biotech (NIV).
COVID-19 vaccination coverage in India is approaching 100 crores, having surpassed 95.89 crores on Tuesday morning. The world’s largest vaccine drive began on January 16 of this year, and the country administered 65,86,092 vaccine doses on Monday. Over 27 crore eligible Indians have been fully immunised against COVID-19 so far.