New Delhi: Covid vaccinations for children and adolescents can turn out to be a game changer and enable return to normalcy among the young population, said public health experts.
The Drugs Controller General of India on Tuesday granted the Hyderabad-based drug maker Bharat Biotech’s Covaxin an emergency use approval for children in the age group of 2 to 18 years.
Covid-19 infection was comparatively less severe for children and adolescents than among the adults. The infection was reportedly 4 per cent among children in the first wave, whereas in the second wave, it surged to 10-15 per cent. However, more than infection, the life of children was hampered due to fears, and subsequent lockdowns affected their studies and other activities, scarring their childhood memories.
“The news is very encouraging. I am very much sure that this initiative will be a game changer to protect our children and adolescents,” Dr Sujeet Ranjan, Head Nutrition, Tata Trusts told IANS.
“In India, best efforts have been put into protecting children after the warning from the experts and the dangerous second wave. With schools reopening in many states for certain age groups, the vaccine for children 2-18 years will help them return to normal,” he added.
In a statement, Bharat Biotech said it had submitted the trial data of phase 2 and 3 of Covaxin on children to the Central Drugs Standard Control Organisation (CDSCO) at the beginning of this month.
While data on these trials has not been made public yet, tests were conducted on more than 1,000 children across the country. “The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations,” read the statement from the company.
The expert panel noted that the trial on kids showed similar efficacy rates as that on adults. However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.
“After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations,” the expert panel said in a statement.
Dr Rahul Nagpal, Director of Paediatric and Neonatology at Fortis Hospital, Vasant Kunj, said: “The approval to give Covid-19 vaccine to children is very good news for children as well as their parents. This approval will also open the path for children to come back to normal life completely and schools will be functional. With this approval now we can also get rid of this pandemic.”
However, some experts have also raised concerns.
“While it is reassuring to know that the vaccine has worked well in children, rollout in children must be scheduled only when we are confident that adults who are at greater risk of more severe illness have acquired immunity in large numbers,” Public Health Foundation of India President K. Srinath Reddy told IANS.
“Children who are immunocompromised may be given early jabs. Only in 2022, we will be able to judge the need for, and benefits of, mass vaccination in children. Evidence will be available by then, from different countries,” he added.
“If the vaccine safety data is strong enough and we immunise them, it will have a big impact in reducing the transmission of Covid. This will be a major step as school, coaching centres and sport centres are gradually opening.” Dr. Akshay Budhraja, Senior Consultant, Pulmonology, Aakash Healthcare, Dwarka, told IANS.
Meanwhile, the World Health Organisation is yet to grant the emergency use authorisation to Covaxin. The global health body said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much awaited EUL to Covid vaccine Covaxin.
Bharat Biotech added that it is awaiting further regulatory approval from the CDSCO “prior to product launch and market availability of Covaxin for children”.
Once approved, Covaxin will become the second vaccine cleared for use on kids in India. In August Zydus Cadila’s three-dose DNA jab was the first to get approval to be used on adults and children over 12.
Serum Institute’s Novavax — for children between seven and 11 years — and Biological E’s Corbevax — cleared to conduct advanced trials on children above five — are the other potential vaccines for kids.