Over 50 million children in the United States under age 12 could qualify for COVID-19 vaccination as soon as the fall 2021. We are fully vaccinated physicians who want to vaccinate our three young children as soon as possible. When sufficient safety data is available for kids under age 12, we encourage the FDA to grant Emergency Use Authorization (EUA), as they have for children 12-15. Parents like us should have the opportunity to make an informed decision to vaccinate our young kids through an EUA, without having to wait for the FDA to complete the full approval process.
Why are we so eager to have the vaccine available to kids across the country? Significant vaccine hesitancy among adults, new variants fueling outbreaks, and plans to reopen and un-mask across America mean we need to work harder than ever to protect our kids from COVID. Children have borne too much pain from the pandemic already: illness and death, parental loss, economic devastation, school closures, increased mental health burden, and challenges to their social development. Looking at the landscape of the COVID crisis and our national responses, relying solely on vaccinating adults to protect children and stop community spread is not enough. We need to vaccinate children.
High rates of death and complications in adults have made it easy to underestimate the serious, preventable threat COVID poses to children. While COVID is often a mild infection, an estimated 35,000–200,000 American children have been hospitalized and an estimated 300 to 600 children have died from COVID. Over half of these children were completely healthy before contracting the disease. Thirty percent of pediatric deaths are in children under 10 years of age. The severe COVID-associated inflammatory disease MIS-C has hospitalized nearly 4,000 kids and caused 35 deaths. More than half of children with MIS-C are under age 10. These stark numbers are in the setting of drastic restrictions protecting children throughout the pandemic. For perspective, nearly twice as many children died of COVID in 2020 than the number of children who used to die annually of chickenpox before a vaccine was available. Substantially more children have died of COVID than during even the worst influenza seasons. Each death and complication is a preventable tragedy.
As with death and hospitalizations, the scale of the pandemic means that while it’s not nearly as bad in children compared to adults, COVID spread among children contributes to ongoing community spread. Without vaccination, children may ultimately serve as a reservoir of disease, which will spread among children and unvaccinated adults. We’ve already seen states like Michigan, which loosened restrictions on schools and sports, hospitalize a record-breaking number of children with COVID during the most recent surge. In Brazil’s massive surge, the Health Ministry confirms more than 1,300 children (at least 852 under nine years old) have died from COVID. In India, variants appear to be infecting children to a greater degree, causing more illness in children and spreading to adults. These easier-to-share strains will not stay isolated in other parts of the world. If we do not vaccinate entire populations quickly enough, we risk the emergence of a vaccine-resistant strain. Ending the pandemic requires a global vaccine strategy that includes children.
Some have questioned whether the virus poses enough of a threat to young children to warrant an emergency use authorization. Potential benefits in preventing severe, life-threatening COVID, MIS-C, and death in children squarely justifies considering vaccination under EUA. Federal research guidelines already require strict protections for children to even participate in vaccine studies, ensuring the risks of participation are justified by the anticipated benefits. Before applying for an EUA, vaccine makers must include at least two months of follow up data to assess the effectiveness of vaccination and the benefit-risk profile.
Based on historical vaccine experience, the chance that a potentially terrible side effect will emerge greater than two months after vaccination is thankfully low. It’s reassuring to see that vaccine makers waited to open enrollment to young children until after millions of adults were vaccinated, demonstrating remarkable effectiveness and safety. It is always possible that a serious side effect could emerge after millions of people are vaccinated. Vaccine makers are taking this seriously as well, as seen when Oxford-AstraZeneca promptly paused their study of 6-17 year olds when reports emerged of rare blood clots in adults (there have not been safety concerns in the pediatric trial itself). Thankfully, the months of safety data collected on teens were sufficient for the FDA to determine the Pfizer-BioNTech vaccine is safe and effective enough to directly benefit children aged 12-15. Waiting for more months of safety data for full approval is highly unlikely to change the experience for the overwhelming majority of people who are vaccinated, but will mean more children get sick, more develop MIS-C, and more children die from COVID, all while further dragging out the pandemic.
Those human costs are critical when we think about long term effects of vaccination: the primary long term effect in every other vaccine is a high rate of disease prevention. As parents, when we weigh the chance of a serious but as-yet unknown side effect greater than two months after vaccination against the very real risks of the virus and an ongoing pandemic, the choice is obvious: we want to vaccinate our kids. Indeed, one risk is relatively low and static (side effects of vaccination) and the other risk is severe and may only grow worse with new variants.
As parents and physicians, we can’t help but worry about ongoing, significant COVID vaccine hesitancy in adults. Without high rates of vaccination, we will live with cyclic outbreaks, negatively impacting children’s welfare and safety. Given lagging adult vaccination rates, we are skeptical we can reach stable herd immunity without vaccinating at least some of the 50 million U.S. children under age 12. Large pockets of low vaccination rates among adults means many localities and regions are particularly at risk for outbreaks which will likely infect children. Reaching and maintaining a stable herd immunity must take into account that while the COVID vaccines are remarkably effective, they are not perfect; we expect a small but real level of breakthrough infections even among vaccinated people. Additionally, the vaccine may not be effective in the estimated 3-4% of Americans are immunocompromised (for example, due to chemotherapy). Keeping children and communities safe from infection requires continued mitigation efforts and lower community spread. Vaccinating children directly protects children, and as a bonus, protects the adults around them, even if some adults cannot or will not vaccinate themselves. Ending the pandemic is the best thing we can do for our children.
The scale of the pandemic is why we have a EUA process: to quickly respond to the devastating threat of public health emergencies. Childhood vaccination is a cornerstone of public health. Generations of children vaccinated against other devastating diseases confer safety for themselves, with further benefit to those around them who cannot be vaccinated. We have long vaccinated children against infectious diseases, many which are far less dangerous than COVID. Making our kids wait for full FDA approval dismisses the serious, life threatening risks children face in the pandemic. As parents and physicians, we see the big picture and the need to accelerate the availability of vaccinations for all our kids as the EUA process was designed to provide.
Editor’s note: This article has been updated to include an estimated range for pediatric hospitalizations.