In the catacombs of online message boards and social media posts – controversy about the various COVID-19 vaccines is rampant. While any new medical intervention should be greeted with healthy skepticism and scientific rigor, the COVID-19 vaccines seem to have taken on a life of its own. To some, they are a marvel of modern medicine to be hailed as an unquestioned panacea. While to others, they represent some deep state or other tin-foil conspiracy. There is little sense in giving light or credence to such ideas, however the question of the safety of the COVID vaccine in children is both crucial and, as yet, indeterminate.
Most of the existing vaccines are approved under emergency use, in other words, the illness they seek to address is of such imminent concern that the available evidence of efficacy and safety (possibly incomplete though it may be) outweigh the risk of leaving the disease unabated. Critics often point out that this means that these vaccines have not undergone the same rigorous standards of safety that their fellow therapies have undergone. In a sense, this is true. The trials, involving approximately 20,000 people, have excluded some segments of the population especially when the administration of the vaccine may pose additional challenges. For example, none of the vaccines have been substantially tested in pregnant women. Likewise, children have also been largely omitted from the clinical trials of these vaccines. While preliminary trials are now underway to assess the safety of vaccines in adolescents, it will likely be much later before any such considerations are going to be made for children.
Why all the fuss? Well, the challenges of testing any drug in children are profound. For one, dosing has to be tailored to the specific child. An underweight four year old and an heavy-set 11 year old will require a substantially different dose of a drug for it to reach the same levels in their growing bodies. This is why vaccines are often administered by age groups. By approximating a child’s height and weight by age, vaccines are able to be dosed in a relatively consistent manner. In dealing with this pandemic, we will not have this luxury. If we are to begin a vaccination trial of children, the vaccine will have to be effectively dosed per child, every time. This astronomically raises both the administration costs of the study as well as the subsequent time and resources required to observe the safety and efficacy of the vaccines.
Ultimately, the data available to date on the safety of any major COVID vaccine in children is, at best, ambiguous. It is overwhelmingly likely that these vaccines, now well established to exceed safety standards for adults will similarly be safe in children, if dosed and delivered appropriately. However dealing with these questions means expensive pediatric trials, and for now, they remain beyond the horizons, and frankly the needs of the pharmaceutical industry.