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DCGI seeks ‘technical opinion’ to approve Covaxin for kids

Schools in India have reopened with kids back in classrooms, however, they haven’t been vaccinated. India’s Drug Controller General of India (DCGI) is yet to approve Covaxin for children despite its expert committee’s recommendation.

The body says it is seeking additional technical opinion since the prevalence of infections among kids is still low.

In most Indian states, classrooms have been functioning with 50 per cent capacity along with mandatory screening, wider seating arrangements and staggered lunch breaks.

India’s festive season is underway currently which invites potential gatherings across the nation. It is a critical phase as the virus can spread again. Although there are life-saving vaccines and the Niti Aayoog has asserted there are no dearth of vaccines but they aren’t being administered to children in the age group of 2-18 to be specific.

The clearances to vaccinate them have been given, however, the rollout is yet to begin. The big question is should the process be fast-tracked? The indications are strong across the world that the Delta variant has been infecting children.

In the United States, adolescents and children now account for more than one-fifth of the new cases with 22 per cent infection cases. In the United Kingdom, 1 in 14 students in secondary schools have caught the virus and in Brazil, the virus yielded a troubling trend – an alarming number of deaths in kids and adolescents.

Now, all three countries have started immunising their children. In fact, more than 25 countries have been administering doses to those above 12 years of age, some countries have vaccinated children below that bracket.

Most of these countries have already dealt with or are dealing with the second wave of the virus.

In India, last week the subject expert committee(SEC), a body constituted by the Drug Controller General of India recommended inoculating children in the 2-18 age group. The recommendation was made after trials were carried out on 525 children.

The regulator usually takes a day or two to execute such recommendations but this time it has been a week and India’s apex drug regulator is yet to approve Covaxin for children.

It has attributed the delay to “additional technical opinion” which is being sought currently.

VK Paul, chief of India’s Covid task force says technical opinion is required because they want the decision to be taken based on “scientific rationale”, also based on the supply situation of the child licensed vaccines.

“A pragmatic decision can be taken by balancing the supply and the potential eligibility. COVID-19 infections in children are very mild or asymptomatic and that is one side of the story. On the other side, once there is enough vaccine available that can be used in children,” VK Paul said.

The low prevalence of infections among Indian children is being taken into account before the doses are made available.

The situation in the US and UK currently shows that children are at risk, therefore, vaccinating kids could be key in preventing another devastating surge of infections even though “scientific rationale” should be taken into account but as should be data, evidence and global trends.

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