Bharat Biotech’s Covaxin roll-out for children likely in phases

The approval for Bharat Biotech’s Covaxin for use in children as young as two years may be some time away with India considering a phased roll-out of the vaccine for them.

India’s drug regulator is carefully examining the recommendation by the expert panel and evaluating several factors, sources close to the development said. The panel last week recommended granting emergency use authorisation to the vaccine for children in the 2-18 years age group.

“There are several factors that are being considered by the Central Drugs Standard Control Organisation (CDSCO) like what is the performance of the vaccine in young adults (18 years or so). Also, there is an availability problem, which is being evaluated,” said a government source.

Bharat Biotech has been struggling to ramp up supplies of its inactivated virus vaccine, and so far has contributed only 11 to 12 per cent of India’s overall vaccination. Allowing it in the 2-18 years age group may create a sudden spike in demand for the jab, leading to an availability crisis for the elderly and vulnerable, the source said.

India has about 400 million children, of whom nearly 60 per cent, or 240 million, have already developed antibodies, according to sero-surveys.

Covaxin would be the first Covid vaccine globally for children as young as two years, the source said. “Therefore, a careful review of the data is necessary before such an approval can come,” the person added.

Moreover, even after the approval comes, the roll-out for children is expected to be phase-wise. “This was adopted in the case of adults as well. A phased roll-out starting with 12-year olds and above may be adopted. Vulnerable children or those with co-morbidities are likely to be prioritised irrespective of their age group,” another source said. This, however, could not be independently verified from the health ministry.

In the case of adult vaccination, India had prioritised health care and essential services workers, moving on to the elderly and people with serious ailments in the latter phases before opening the vaccination for all.

Public health experts, too, feel that such an approach is desirable. K Srinath Reddy, president, Public Health Foundation of India, said, “We have to lower the age group once we ensure that everyone above 18 years is adequately vaccinated. Then we come to the 12-18 age group, and then we go to the 5-11 years group. The 2-5 age group is not an immediate priority unless we are flooded with vaccines and vaccinators.”

One cannot open all age groups simultaneously, experts said.

On October 12, Covaxin received the nod from the Subject Expert Committee (SEC) that is advising the CDSCO on matters related to Covid-19 vaccines and drugs. The Drugs Controller General of India (DCGI) has acted almost immediately on SEC recommendations in the past. However, for Covaxin’s use in children, it is taking time to review the matter.

The SEC recommendation, too, has come with riders.

Bharat Biotech has been asked to submit safety data, including data on adverse events following immunisation (AEFI) and adverse event of special interest (AESI), every 15 days for the first two months and thereafter on a monthly basis. The firm should submit a risk management plan according to the New Drugs & Clinical Trials Rules, 2019.

Moreover, the SEC has asked Bharat Biotech to continue the study according to the whole-virion inactivated coronavirus vaccine-approved clinical trial protocol. The firm should also provide updated prescription, package insert summary of product characteristics, and a fact-sheet. Business Standard