The subject expert committee under India‘s drug regulator will review Hyderabad-based Bharat Biotech‘s data of its Covid-19 vaccine, Covaxin, for use in children in a meeting likely to be held next week.
The company this week submitted “interim data” from its vaccine trial in children aged 2 to 18 years to the drug regulator, becoming the country’s first company to have tested its Covid jab on children of this age group.
“Here the safety follow-up is longer. So, what we have done is that we have presented interim data. The trial design is such that one month after the two doses, we do an immunogenicity check and we also do a safety follow-up. We call it an interim report until the final safety data is available,” said a company insider. The data indicates that the vaccine is safe for children, the person said.
“Safety and immunogenicity have been completed, long-term follow-up is ongoing,” the person added. The data has been presented to the Drugs Controller General of India. The subject expert committee, after its review, will recommend whether the vaccine can be given approval for use in children.
India will soon have multiple jabs approved for use in children. The first one to be rolled out this month is the Zydus Cadila vaccine, which is for the 12-plus age group.
Last month, the drug regulator also allowed Serum Institute of India to expand its Covovax trail to include children in the 2-6-year group.
The government is gearing up to give a go-ahead to inoculate children over the age of 12 years with underlying medical conditions, while healthy kids are unlikely to get jabs this year. According to government experts, there is no need for every child to be vaccinated to attend school.
Children in the priority group may include those who have undergone kidney transplant, have congenital heart disease and illnesses. The guidelines for vaccinating such children are likely to be issued soon.
