India is preparing to save its future generation from an anticipated third wave of coronavirus that could hit children hard, warn experts.
A government panel of experts on Tuesday recommended phase-2 and phase-3 clinical trials of a COVID-19 vaccine on those aged between 2 and 18 years of age.
Covaxin, manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research, which is being used in adults in the ongoing vaccination drive, has been given the go-ahead for trials in children.
The trials will take place in 525 subjects at various places across the country, including the All India Institute of Medical Sciences in Delhi and Patna in Bihar and the Meditrina Institute of Medical Sciences in Nagpur.
The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation mulled over the proposal by Bharat Biotech, reported PTI, seeking permission to conduct phase-2 and phase-3 trials to evaluate the safety and reactogenicity of Covaxin jabs in children aged 2 to 18.
Emphasising the need to protect children from the next wave of coronavirus, Dr Bhavneet Bharti, a pediatrician and director principal of the Government Medical College and Hospital in Punjab's Mohali, told Sputnik, "The second wave impacted people who were not affected earlier. Children will now have to be protected. When we do vaccine trials, we generally exclude children, pregnant women, and lactating mothers. Now having seen the second wave, we feel we need to be prepared. We must work out the safety of vaccines for children and scale up their vaccination as early as possible".
The go-ahead for clinical trials of inactivated coronavirus vaccine in children has been given provided that the firm submits its interim safety data for phase-2 clinical trials before proceeding to phase 3 of the study.
The proposal for clinical trials among children was raised a few months ago and it was discussed by the expert committee on 24 February, when the firm was asked to submit a revised clinical trial protocol.
Several states in the country have stepped up preparations to face the third wave of COVID-19. Pune in the state of Maharashtra, one of the worst hit by the second wave, has started putting in place ICU beds for children in anticipation of the third wave.
The Pune Platform for COVID-19 Response, a virtual platform of all stakeholders working to support the healthcare system, patients, and families dealing with the pandemic, has asked all hospitals in the city to set up paediatric intensive care units.
Several children below the age of 18 and newborns have tested positive for COVID-19 in Maharashtra's Akola and Amravati districts, with nearly 12 percent of COVID-19 cases reported in those below 18 years of age.
As a measure to prevent the spread of infection in children, the federal and the state governments have not allowed schools to start teaching offline. Attempts by a few states like Punjab, Odisha, Kerala, and Maharashtra to begin offline classes were stalled after the virus spread on school and college campuses.
The federal government, which had earlier decided to hold physical, in-person tests children appearing for board exams for classes 10 and 12 in May and June, decided to hold the exam online after an outcry in the country over their safety.