The Government’s decision to begin the COVID-19 immunisation programme for children between 12 and 14 years with Corbevax, a protein subunit vaccine, from March 16, is welcome as a part of India’s efforts to extend coverage to the school-going population, but it also raises some concerns. One is the urgency shown to greenlight the vaccination programme for children in this age group without first seeking the approval of the National Technical Advisory Group on Immunization (NTAGI), a body whose express mandate is to study various facets of the vaccine before clearing it for the national immunisation programme. Never before has the expert body been completely sidestepped to clear a vaccine for the immunisation programme, and by doing so, has set an unhealthy precedent. Also, the decision to use the new COVID-19 vaccine first on children between 12-14 years without widespread use in adults first could have been avoided. True, protein subunit vaccines are generally considered safe for all age groups, but that cannot be a reason to begin vaccinating young children first. Any serious adverse effects seen once the immunisation programme begins might cause vaccine hesitancy and jeopardise the immunisation programme using other vaccines for children. It is perplexing that Covaxin, which has been used for immunising adults and adolescents between 15 and 18 years and whose safety profile is now known, has been excluded for children in the 12-14 age group.
Earlier, concerns were raised about the absence of efficacy data for Covaxin at the time of approval by the Indian drug regulator and about its inclusion in the immunisation programme from mid-January 2021, which arguably led to vaccine hesitancy in the beginning. No lessons seem to have been learnt. Greenlighting Corbevax for children in the 12-14 age group, even when data on safety, immunogenicity and efficacy have not been made available even as preprint (it is not peer reviewed), is inexplicable in the current situation, which can no longer be described as an emergency. The fourth national seroprevalence survey that was done soon after the deadly second wave peaked revealed that 67.6% of the population above 10 years had antibodies against the virus. The percentage of children in the 12-14 age group who would have been infected during the third wave driven by the extremely infectious Omicron variant might be staggeringly high. If children have been found to be much less likely to suffer from severe disease and death, the high seroprevalence in this age group even before the third wave makes it even harder to fathom the urgency shown by the Government to vaccinate this subset of children. Evidence-based policy making should not be jettisoned even if, or rather especially if, a pandemic is raging.