The Subject Expert Committee (SEC) has given a recommendation to Drugs Controller General of India (DGCI) for the use of Bharat Biotech's Covaxin for 2-18-year-olds, news agency ANI reported on Tuesday, 12 October, quoting official sources.
This makes Covaxin only the second vaccine to be approved for children in India, and the first ever in the world to be approved for children below the age of 12.
The other vaccine that has been approved for children above the age of 12 is Zydus Cadila's ZyCoV-D.
Which other vaccines are in the pipeline? When can children be vaccinated against COVID-19? Here's all you need to know.
When can children get vaccinated for COVID-19 in India?
According to FIT, the government plans to begin vaccinating children in the 12-17 age group, who have comorbidities, by mid-October.
Previously, amid the imminent third wave of COVID-19, the Union health minister Mansukh Mandaviya and All India Institute of Medical Sciences (AIIMS) Chief Randeep Guleria had said that vaccination drive for children would be commencing in September.
Which vaccine is likely to be rolled out for children first?
In August, the DCGI had given Gujarat-based Zydus Cadila’s three-dose COVID-19 vaccine emergency use authorisation for use in adults and children above 12 years.
The needle-free, three-dose vaccine will potentially be the first vaccine to be administered to the adolescent group in India, FIT reported.
ZyCoV-D is the world's first COVID-19 vaccine built on a DNA platform to be granted emergency use authorisation.
What other vaccines are in the pipeline to be approved for use among children?
Serum Institute of India's Covovax
Johnson & Johnson
Biological E's Corbevax
What is Covaxin's trial status among children?
According to FIT, the data from Phase 2 and 3 clinical trials conducted on children aged between 2 and 18 is still awaited.
The DCGI had given a nod to the company to conduct Phase 2 and 3 clinical trials in May this year. The trial was conducted in June on 528 children with 28 days apart. The results have not yet been made public.
What is the status of other vaccines?
Pune-based KEM Hospital and Research Centre has begun enrolling children for Phase 2-3 clinical trials of Covovax for those aged 2-17 years with a sample size of 920 children in two age groups across 10 test sites, The Indian Express reported.
The trials for the first group will be conducted for those between 2 and 11 years and the second between 12 and 17 years, FIT reported.
Covovax has been developed by American biotechnology company Novavax. Serum Institute of India, which is producing the vaccine, will conduct the trials in India.
J&J is currently awaiting permission to conduct COVID-19 vaccine trials for children aged 12-17 years in India, FIT reported.
It has already received emergency use approval for its single-dose vaccine, which will be supplied via an agreement with Hyderabad-based Biological E Limited.
Earlier in September, the DGCI gave permission to Biological E to conduct Phase 2-3 clinical trials of Corbevax for children between 5-18 years, with certain conditions.
As per reports, Corbevax has Phase 3 trials underway and will be released by October, FIT reported.
(With inputs from FIT.)
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