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Regulator to study Covaxin data before nod for minors

DCGI had sought additional information on two specific areas of Covaxin paediatric clinical trials: the number of children and the disaggregated age groups; and what the adverse events following immunisation were among these groups.

Written by Kaunain Sheriff M | New Delhi |
Updated: November 15, 2021 7:17:39 am
DCGI received a recommendation from the Subject Expert Committee on October 12 to grant emergency use authorisation for the Bharat Biotech-made vaccine for the 2-18 age group.

India’s drug regulator will take a final call on approving Covaxin for minors after examining the “voluminous additional data” it has recently received on adverse events following immunisation reported in the vaccine’s paediatric clinical trials, The Indian Express has learnt.

Top government sources told The Indian Express that the Drug Controller General of India (DCGI) had sought additional information on two specific areas of Covaxin paediatric clinical trials: the number of children and the disaggregated age groups; and what the adverse events following immunisation were among these groups. In response, Bharat Biotech has “recently” submitted the voluminous data to the drug regulator, sources said.

DCGI received a recommendation from the Subject Expert Committee on October 12 to grant emergency use authorisation for the Bharat Biotech-made vaccine for the 2-18 age group.

“The information is voluminous. The regulator is studying and scientifically scrutinising it. After this, the regulator will take a final decision on the grant of EUA for Bharat Biotech’s Covaxin for the age group of 2-18 years,” one source said. The National Technical Advisory Group on Immunization (NTAGI) will make recommendations to the government for use of Covaxin in minors in the national immunisation drive only after a final decision is taken by the drug regulator, sources said.

NTAGI is the advisory body on immunisation. It provides guidance to the government on vaccination by undertaking technical reviews of scientific evidence on matters related to immunisation. The Subject Expert Committee’s emergency use authorisation is among the first expert approvals in the world for a Covid-19 vaccine for the 2-18 age group.

Unlike the other approvals for Covid-19 vaccines, however, the drug regulator did not immediately approve Covaxin on the basis of the recommendation. Instead, it is independently conducting a detailed scrutiny of the data of the paediatric Covaxin trials. “The scientific bodies will not rush the process. The final call be taken with extreme caution and care,” a source said.

In parallel, the standing technical sub-committee of the NTAGI, sources, said, is in the final stages to recommend “if and when, vaccination for children is rolled out, whether it should be graded based on age or whether it should be graded based on comorbdities”.

NTAGI is in the final stages of its deliberations to recommend Zydus Cadila’s three-dose Covid-19 vaccine for minors. Sources said that besides deliberating on child vaccination, the sub-committee of NTAGI is also examining two other issues: the need for a booster dose; and vaccine mixing.

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