The vaccine manufacturer had completed the Phase 2/3 trials of Covaxin for use in children under 18 years of age in mid-September
HYDERABAD: The Subject Expert Committee (SEC) on Covid-19 has recommended that the Drugs Controller General of India (DCGI) grant emergency use authorisation for Bharat Biotech’s Covaxin for children in the age group of two to 18 years, who constitute 41 per cent of the population.
This does not mean that the vaccine will become immediately available for children. There are more steps ahead.
The SEC clearance will be evaluated by two more panels — the technical expert committee and the apex committee. These panels will make their own recommendations.
The DCGI has to then officially give the green signal to launch Covaxin for children. This clearance has still not been given by DCGI.
Once the vaccine is granted final approval by DCGI, Covaxin will become the second vaccine cleared for use for children in India. In August, Zydus Cadila’s three-dose DNA jab was allowed to be used on adults and children over 12.
Covaxin, when approved, will be administered in children in two doses, with a gap of 28 days between the first and second doses. The gap and dosage of vaccine for adults and children will be the same according to the trial data submitted to the government.
The committee noted that Covaxin tested on children was the same formulation as used on adults, but separate trials were needed to guarantee safety and efficacy on younger recipients. It noted that the data of the trials conducted on over 1,000 children across the country showed similar efficacy rates against Covid-19 as that on adults — 77.8 per cent.
There are four conditions which have been put in the emergency use authorisation where the company has to continue its studies on the inactivated Covid-19 virus, provide updated information and factsheet of the product, submit safety data and adverse events every 15 days for two months and a risk management plan.
The data of 525 children has been submitted by the company to the Central Drugs Standard Control Organisation (CDSCO) and reviewed by the subject expert committee. There were a total of 1,000 children who were recruited for the trial. There were 60 children from Hyderabad in the age group of 12 to 18 years.
They were followed up for one month after the two doses of vaccine and are also on the radar for the next three months, according to company sources.
The company had completed Phase-2 and Phase-3 trials of Covaxin on children between the ages of two and 18 years in September and submitted the trial data to the DCGI in the beginning of October.
A doctor from Secunderabad told this correspondent that his 13-year-old son had taken part in the trial in Hyderabad. “There have not been any side-effects related to the vaccine. Others with him too are safe. This is a big relief for parents,” the doctor said.
Dr T.P. Karthik, senior paediatrician, said parents wanted the vaccine to be rolled out to all private hospitals so that children suffering from chronic diseases and those who are immunodeficient are prioritised in the vaccination process.
Dr Bipin Singh, an associate professor, said, "It would be better if the vaccine was first approved for children in the age bracket of 10 to 18 years. Based on a large and diverse pool of clinical trials data, the long-term evaluations would give a balanced real time data. It is very interesting to observe that the DCGI has given a nod on a very small clinical trial data compared to the much larger data that they sought for adults. Paediatric population cannot be treated equivalent to adults."
Other paediatricians state that there are about 10 to 15 different vaccines which are given to children from 0 to 2 years of age. There is also a booster dose given to children at 5 years of age. With so many vaccines, Covaxin in children from two years old is raising concerns and they want that only those who are immune compromised, suffering from diseases and co-morbid conditions must be made eligible for vaccines first.