AIIMS-Delhi begins screening children for COVAXIN clinical trials from today
The All India Institute of Medical Sciences (AIIMS), Delhi will begin screening children from Monday to conduct clinical trials of the indigenously developed, Bharat Biotech's vaccine against COVID-19, COVAXIN. The clinical trials are crucial to determine if this vaccine is suitable for those aged between two to 18 years. Notably, last week, AIIMS-Patna had already begun COVAXIN clinical trials on children. Here's more.
The development comes amid experts' warnings of a possible third COVID-19 wave in India during which children are more likely to get infected. Experts say the first wave affected older people, while in the ongoing second wave, youngsters are getting more infected; the third wave could be dangerous for children. Hence, ensuring vaccination of children is crucial to deal with the third wave.
While India is administering COVAXIN, Covishield, and Sputnik V as part of its vaccination drive, none of these are approved yet for children. However, the Drugs Controller General of India (DCGI) last month approved Bharat Biotech to conduct COVAXIN Phase 2/3 trials on children, followed by a recommendation by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO).
The COVAXIN Phase 2/3 trials would be conducted on 525 subjects aged between two and 18 years. The two-dose vaccine will be administered 28 days apart. The trials would be held across numerous sites, including AIIMS-Delhi, AIIMS-Patna, ESI Hospital, Basaidarapur (Delhi); Prakhar Hospital, Kanpur; Mysore Medical College and Research Institute, Mysuru; Pranaam Hospital, Hyderabad; and Meditrina Institute of Medical Sciences, Nagpur, beginning this month.
To recall, AIIMS-Patna had begun the Phase 2/3 clinical trials of COVAXIN on children on June 3. Dr. CM Singh, AIIMS-Patna Superintendent and the Principal Investigator of the trials, said these clinical trials will be conducted in the reverse order of age: the 12-18 years age group will be inoculated first followed by the 6-12 years and 2-6 years age brackets.
While India is yet to approve a vaccine for children, several countries like the US, the UK, and Canada have authorized vaccines for some age groups. The US, the UK, and Canada cleared Pfizer-BioNTech's vaccine for those aged 12-15 years, while China recently authorized the use of Sinovac's CoronaVac for children aged 3-17 years. However, most countries are yet to immunize kids against COVID-19.
Meanwhile, many states in India have started preparing for the expected third wave, focusing on strengthening healthcare infrastructure, especially for children; several states are also setting up Pediatric Intensive Care Units (PICUs). On the other hand, the COVID-19 situation in India seems to be improving gradually. On Monday, the country reported 100,636 cases in the last 24 hours—the lowest single-day spike in two months.
