As the impact of India's second wave of coronavirus is said to be worse on young people, especially children, many parents and paediatricians in the country have been especially concerned.
The approval of Bharat Biotech's inactivated virus-based COVID-19 vaccine Covaxin for clinical trials on children above age two is seen as a watershed moment by many health experts.
Bharat Biotech may reportedly start clinical trials on children from June. Currently, pregnant and lactating mothers, special populations, and children are being denied vaccination.
The pharma company has already conducted trials on children aged 12 and above. Covaxin, which was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is currently being used on adults in India's ongoing vaccination drive.
Meanwhile, doctors and experts are consistently warning that the anticipated third wave will affect the under-18 population, and it would be a ‘very, very serious’ form of COVID-19.
A 'Reassuring' Move
Dr. Baldeep Singh, MD (Paediatrics), Director and Department Head at Deep Hospital (Ludhiana), says the paediatric age group consists of everyone under 18 years of age and the response of the vaccine can be different when administered to children from different age groups.
He says, therefore, the ideal scenario would be to include healthy kids of different age brackets to be able to receive accurate findings from these trials.
"The best answer to have protection against this challenge is vaccination. This move by the government to give an emergency nod to Covaxin is very reassuring. Bharat Biotech is accredited with a huge legacy and highly experienced team comprising Dr. Krishna and Dr. Raches Ella, who will prove to be absolute game-changers in protecting kids from this deadly virus," Dr. Singh told Sputnik.
On Thursday, Dr. V. K. Paul, the head of India’s COVID-19 task force, said he has been told that the Pune-based Serum Institute of India (SII) intended to start a clinical trial of the Novavax vaccine on children. The SII is manufacturing US biotechnology company Novavax’s protein-based COVID-19 vaccine, NVX-CoV2373 under the brand name Covovax.
Currently, the World Health Organisation (WHO) has not given any recommendation regarding vaccine trials on children.
"Although children with existing disabilities and disorders are normally administered with regular Indian Academy of Paediatrics (IAP)-approved vaccines, we cannot be certain at this stage about the exact outcome of these vaccines on those with conditions such as congenital heart disease, cystic fibrosis, storage disorders, IEM, etc. Hence, it would be best that the trials are not done on such children. Additionally, children who have in the past undergone or continue to undergo treatment for any childhood malignancies should also be kept out of these trials," Dr. Singh said.
Special Needs Kids
However, some experts also believe that since certain children are immunocompromised because of a particular disease or disorder, they should be prioritised for vaccination trials to study the behaviour of the present vaccine on such children.
"Under the Universal Immunisation policy, special needs children are given the same vaccination as healthy children, leave apart a few exceptions of live vaccines. As the vaccine trial consists of dead virus, theoretically it should be safe, but definitely, a trial is [needed] just before the general recommendation," Dr. Puja Kapoor, Paediatric neurologist & Co-Founder of Continua Kids, told Sputnik.
Although COVID-19 rarely creates serious complications in children at present, the number of infected kids has been growing amid the second wave. Presently, the 0-18 age group is the only population segment to be denied inoculation, as the vaccination is now open for all citizens above the age of 18.
"The impact on kids, if vaccinated fully, would be that they can resume school and lead a near-normal life and have less risk of infection, and will be able to connect with friends," Dr. Vinit Samdani, Pediatrician at Bhatia Hospital, said.
This young age cohort accounts for over 30 percent of the total population of the country. A number of experts believe that this is a critical step to ensure a break in virus transmission.
According to Dr. (Maj) Manish Mannan, Head of the Department of Paediatrics & Neo-natology, at Paras Hospitals, Gurugram, with the raging pandemic, it’s important for the kids to get vaccinated.
"Like in any trial of a vaccine, we first vaccinate the healthy adults followed by the lower age groups. Desperate times call for desperate measures. I don’t think people should criticise this. It’s an important thing. Almost every day parents ask us when the vaccines will come out for the kids. We don’t know how the future Covid waves are going to affect the kids and if the severity is going to be more. It’s better to be prepared to prevent rather than just saying it’s not required. Covaxin should go ahead with the trials with all precautions taken,” Dr. Mannan stated.
As per reports, Covaxin and two more vaccine candidates would be available for paediatric use in India. Zydus Cadila’s ZyCoV-D has been tested on children above age 12, and the USFDA has authorised the use of Pfizer's mRNA vaccine on kids as young as 12.
Moreover, as kids are generally scared of needles, Cadila Healthcare’s ZyCoV-D would be administered through a needle-free injection system (NFIS).
Typically, in an NFIS, a jet of fluid is accelerated to high speed, providing it significant penetrating power through a fine-diameter nozzle when placed against the skin. This move might increase the acceptance among kids.