By Dorit Rubinstein Reiss
On May 10, 2021 the U.S. Food and Drug Administration (FDA) expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include children aged 12-15.
The vaccine was previously authorized for use in those aged 16 and older. The company has announced it will seek emergency use authorization for younger children by September.
Now that children over the age of 12 can get vaccinated against COVID-19, will immunization against SARS-CoV-2 become a requirement for the return to public schools this fall?
My answer: In the near term, we probably will not see COVID-19 vaccine mandates for school children. And in the longer term, it depends.
Though many colleges and universities have already issued COVID-19 vaccination mandates, there are several important differences to consider for the context of K-12 schools.
First, although there are some university-level mandates in statutes, most higher education vaccination mandates are set by the institution itself. On the other hand, K-12 school vaccination mandates are, in every state, addressed in some detail by state law. Higher education institutions thus have more flexibility and variation regarding vaccination mandates than K-12 schools.
All 50 states and the District of Columbia have school immunization mandates that set out which vaccines are required for schools, which exemptions are permitted, and what the process is. In some states, the authority to add vaccines to the required schedule resides with the state’s health department. In most, the legislature sets the schedule of required vaccines.
To add COVID-19 vaccine to the K-12 roster in any state, there will have to be action by the state. In most states, this will require passing legislation, which can be a complicated endeavor. Passing legislation is a long process that requires political capital. And in this context, we can expect aggressive pushback from the national anti-vaccine movement, which mobilizes to oppose any effort to add to or strengthen school mandates.
This would likely also affect timing: state law makers are unlikely to want to go through a legislative battle on this twice, so are likely to wait until the vaccine is authorized or approved for all school-aged children, and not just those over the age of 12. This makes it highly unlikely there will be a mandate in place for the 2021-2022 school year.
In states where the health department can add vaccines to the required schedule, they may be able to act faster, but would still be subject to the same sensitive political context.
Another legal wrinkle is that currently the vaccines are still under Emergency Use Authorization. There is legal uncertainty around whether you can require a vaccine that has only been authorized for emergency use and not yet licensed by the FDA. Some schools may issue mandates that offer students an opt-out until the vaccines have received full licensure, as, for example, Caltech did.
My view is that there are good arguments for the legality of a mandate for an EUA vaccine. But there are arguments the other way, and there is no legal precedent on this, though there are several cases in the courts now. This legal risk may affect decision-making around K-12 mandates. That said, by the time a legislative school mandate has passed or become operative this issue may be moot, since Pfizer has already applied for a full biologic license.
Whether we should mandate COVID-19 vaccines for school children is a different question, which, for me, at this point, does not have a clear answer.
COVID-19, while typically less fatal and severe in children, still poses significant risks to young people. Hundreds of children have died from COVID-19 and at least tens of thousands have been hospitalized in the past year. The long-term effects of COVID-19 on children are not yet fully known; we already know that in rare cases, children may develop a long-term syndrome — multisystem inflammatory syndrome in children — that can leave them with permanent harm and potentially shorten their lives.
Children can also transmit the disease to adults, including caretakers. Already tens of thousands of children have lost parents due to COVID-19. Requiring vaccination of school children will further protect their families and other adults they come into contact with, such as school staff.
On the other hand, we are seeing dramatic declines in COVID-19 in both Israel and the UK without vaccinating children, but with high percentages of the adult population vaccinated. And even without a mandate, enough children may be vaccinated to achieve herd immunity in school. If a mandate is not needed, we should not adopt one.
In an ideal world, by the time school mandates are feasible — which I suspect would be when the vaccine is available to children five and up, not only 12 and up — COVID-19 would be sufficiently under control that school mandates would not be necessary. My hope is that we will not need them.
However, this depends on achieving good control of COVID-19 outside of schools. This is where vaccinating adults becomes critically important. The potential evolution of the virus also matters a great deal: if it becomes substantially more dangerous to children, or spreads more because of variants, mandates may be necessary.
If communities have not controlled COVID-19 sufficiently by other means, and if the documented risks of the vaccines continue to be absolutely very small, and relatively much smaller than the virus, communities may be justified in considering school COVID-19 mandates.