A few months ago, during the second wave of covid, unproven medicines and therapies as well as excessive medical investigations were rampantly being prescribed. Patients who needed no medication were often prescribed a range of antibiotics, steroids and even blood thinners. This was demand-driven (people were actively demanding therapies such as convalescent plasma) as well as supply-induced (steroids are cheap and easily available and many medicines still under observation were being promoted). All this arguably resulted in less benefits than harm, such as the mucormycosis crisis, black marketing of medicines and higher costs of care.
With the first covid vaccine for 12- 17-year-olds being given an emergency-use licence, India could land up in a similar situation again. Parents have begun to demand that children be vaccinated. Vaccine makers are talking of prioritizing supplies for schools and children. This demand by parents and messaging by manufacturers are unhelpful to the cause of independent decision-making. The licensing of vaccines is a process completely independent of technical recommendations on who should be eligible for vaccination. Though these happen in sequence, the final call on vaccinating kids should be based on scientific evidence and kept free of any external expectations or demands.
The Sars-CoV-2 virus affects all age groups. Therefore, it is natural to conduct clinical research on covid vaccines among all age groups. For a new pathogen, it is an ethical requirement that any new medicine or vaccine undergo a clinical trial among adults first, and only once it’s proven safe should we enrol children for subsequent trials. The licensing of a vaccine for 12-17-year-olds is an indication that it has undergone its due clinical trials and has been found both safe and efficacious. Thereafter, whether this age group is to be vaccinated or not is a decision for which we need an analysis of scientific information on its need, benefit and risks.
In India, parental demand for vaccinating children is linked to the reopening of schools. However, much of the discourse is based on misinformation. The fact is that vaccination is not a prerequisite to open schools. No country in any part of the world is administering covid vaccines to children younger than 12 years. Yet, schools in most countries are open. Second, the main role of a vaccine is to prevent moderate to severe disease and death. However, as children are at far lower risk of moderate to severe covid and mortality, the benefits of vaccinating children are also much lower than for adults.
Further, if the idea is to vaccinate children to reduce transmission, then it is completely misplaced, as there is very little evidence to show that the vaccines currently in use reduce transmission. To make schools safe, interventions such as improved ventilation and the use of masks are far superior.
There are other considerations which warrant that a decision on vaccinating children be taken with caution. The number of children included in the majority of either completed or ongoing clinical trials for covid vaccines ranges from a few hundred to 1,000. While this is a reasonable size to provide data on safety and immunogenicity, the incidence rate of some adverse events, both common and rare, is always slightly higher among younger age groups. This is true for all vaccines. However, the first covid vaccine licensed for children in India uses an entirely new platform, DNA plasmid. Therefore, it would be wise to use this vaccine first among adults and generate additional real-world data before recommending it for children.
Globally, only a handful of countries have started vaccinating 12-17-year-olds, and these are those that have achieved high adult coverage and secured far more vaccine doses than they need. For this age group, there is evidence to favour vaccinating only a select sub-group of high risk children, as has been adopted by the UK.
In covid case management, the role of evidence-based standard treatment guidelines (STG) is paramount. However, Indian STGs for covid management had included unproven medicines and therapies. Medical practitioners around the country followed their own approaches to treat patients. In making a decision on covid vaccination of children, India must avoid the mistakes made in case management. Its decision should not be influenced by what parents want or by influential voices that are not necessarily logical.
The decision on whether, when, how and with which sub-group to start covid vaccination of the country’s 12-17-year age cohort lies with a covid vaccine expert group under the National Technical Advisory Group on Immunisation. In the current discourse, which is charged not just with parental pleas but also some paediatric task-forces seeking vaccination arrangements for children, this vaccine expert group bears a special responsibility. Apart from scientific data, vaccine supply and delivery factors would have to be taken into account. It’s important for the country’s political leadership to refrain from interfering in this, as seemed to be the case with the opening of vaccination for the 18-44-years age group in April. Also, it is time that the vaccine expert group starts communicating with the general public by issuing updates on the scientific rationale of why children (or members of any subgroup for that matter) need to be vaccinated, or not, all of it in lay-person language. Decisions on covid vaccination in India need a double dose of clearer science and greater transparency.
Chandrakant Lahariya is a physician-epidemiologist, public policy and health systems expert and co-author of ‘Till We Win: India’s Fight Against The Covid-19 Pandemic’. Views expressed are personal.