SII gets nod to enroll children in 7-11 age group for COVID vaccine trials

In a significant development, the Indian government has given the nod on Tuesday for India’s Serum Institute to enroll children between seven and 11 years of age for its COVID-19 vaccine trial.

A subject expert panel of the Central Drugs Standard Control Organization said that the committee has allowed subjects of 7 to 11 years age group as per the protocol for COVID vaccine trials after much deliberation, Reuters reported.

Serum Institute, which has administered nearly 870 million doses to adults in India, is already busy conducting a trial of its COVID-19 vaccine, a domestically produced version of AstraZeneca’s shot, in the 12-17 age group. It has presented safety data for an initial 100 participants, said a report in The Mint.

In August, USA’s Johnson & Johnson too had sought the Indian drug regulator’s permission to test its COVID-19 vaccine on the 12 to 17 age group, joining a slew of companies seeking to inoculate children against COVID-19.

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So far, drugmaker Zydus Cadila’s DNA COVID-19 vaccine has received emergency use approval in India to be used in adults and children aged 12 years and above, said the Mint report. Hyderabad-based Bharat Biotech too has completed the Phase 2 and 3 clinical trials of coronavirus vaccine, Covaxin for use in the age group of 2 to 18 years.

An opinion piece titled ‘Reopening of schools during COVID-19 pandemic: A persistent dilemma’ published in the Indian Journal of Medical Research had stated that there is ample evidence to suggest that children aged 1-17 years have similar susceptibility to a mild form of SARS-CoV-2 infection as in adults. However, the risk of severe disease and mortality in children is less.

The fourth round of the National Serosurvey for COVID-19 held in June 2021 in India however showed that more than half of the children aged between 6 and 17 were seropositive, which indicated that a considerable proportion of them had been infected with SARS-CoV-2.