The news came on the same day, that Bharat Biotech’s Covaxin received emergency authorisation for use in children over the age of 12 by the Drugs Controller General of India (DCGI).
Covaxin will be administered to children in two doses 28 days apart, as was the case for adults.
The approval makes Covaxin the second in India to be authorised for use on children, with Zydus Cadila’s three-dose jab being the other one. The latter received approval for use on both adults and children over the age of 12 in August.
There are other COVID-19 vaccines for children in the works. Last month, the DGCI gave approval to Serum Institute’s Novavax for clinical trials on children aged above 11 years. It has also cleared Biological E’s Corbevax for advanced trials in children above the age of five.
These developments come in the backdrop of a surge in cases across the country as the threat from the Omicron variant of the virus continues to grow.
How do you register for a vaccine for children in India?
According to reports, a top official said that children in the age group of 15 to 18 years would be able to register on the CoWIN app from January 1, two days before the vaccination programme starts to cover them.
On vaccination of children, the ministry guidelines said, “For such beneficiaries, option for vaccination would only be available for Covaxin as this is the only vaccine with EUL (emergency use listing) for the age-group 15-17,” reported PTI.
“We have added an additional (10th) ID card for registration, the student ID card, because some might not have Aadhaar or other identity cards,” RS Sharma, chief executive officer of the National Health Authority, which operates the CoWIN platform, was quoted as saying by news agency ANI.
But are children at risk of COVID-19?
Studies and evidence from the ground have pointed that kids tend to have milder disease as compared to adults.
In its interim statement on COVID-19 vaccination for children and adolescents in October, the World Health Organisation (WHO) said, “Overall, there are proportionally fewer symptomatic infections, and cases with severe disease and deaths from COVID-19 in children and adolescents, compared with older age groups.”
But results from studies conducted around the world at different points of time, have been mixed. A serosurvey done in India during June-July 2021 after the second wave (Delta variant) showed that seropositivity in children 6 to 18 years was similar to that in older age groups – except in those older than 60 years in whom the immunization rate was high.
“Thus, it appears that children of all ages can become infected and can spread the virus to others,” the WHO said.
Are COVID vaccines safe and efficacious for children?
Several drugmakers have been conducting trials to determine the safety and efficacy of vaccines for children.
In Phase 2/3 trials for both the Pfizer-BioNTech and Moderna COVID-19 vaccines, efficacy and immunogenicity were similar or higher compared to adults; and safety and reactogenicity profiles in adolescents were similar to young adults.
In India, Bharat Biotech had reportedly submitted the results of phase 3 clinical trials on children aged between 2 to 18 years to the DCGI in August for review, based on which a subject expert committee recommended the vaccine for the same age group in October.
The DCGI’s final decision to authorise the use of the vaccine for children over the age of 12 came almost two months after.
Notably, the results of the clinical trials conducted by Bharat Biotech are yet to be made public.
Dr NK Arora, chairperson of COVID-19 working group of the National Technical Advisory Group on Immunisation in India (NTAGI), said on Sunday Covaxin has shown that it has a very good immune response in children in trials.
“In fact, it is slightly better than adults. Secondly, this vaccine is a safe vaccine, and even local effects like pain, swelling in the arms are much less as compared to adults. We would like to offer this protection to our adolescents,” Arora said in an interview with news agency ANI.
Earlier in October, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer vaccine for children aged 5 to 11.
“The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study,” the FDA said.
What should countries consider before beginning vaccination for children?
In its statement, the WHO has called for countries to look at the individual and population benefits of immunising children and adolescents in their specific ‘epidemiological and social context’ when developing their immunisation strategy.
“As children and adolescents tend to have milder disease compared to adults, unless they are in a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers,” the health body has said.
The Centers for Disease Control and Prevention (CDC) of the US, recommends a COVID-19 vaccine for children aged 5 years and older. “Vaccinating children can help protect family members, including siblings who are not eligible for vaccination and family members who may be at increased risk of getting very sick if they are infected,” it said.