The Volokh Conspiracy

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Resist the Anti-Vaxxers: Approve Vaccines for Kids 5-11

The FDA needs to put actual lives over politics


[This post was coauthored with Prof. Daniel I. Morales from the University of Houston Law Center]

In the United States, the anti-vaxxers are winning, and some of the biggest victims are children under twelve. Unlike in the countries that have handled COVID-19 successfully, such as Israel, we have no vaccine verification system and few limits on access to public spaces for the unvaccinated. In most of the United States, unvaccinated people can cram into a bar or plane without as much as a COVID-19 test. All these policies that let unvaccinated adults roam "free" endanger children not yet eligible for the vaccine, reducing their choices.

To add insult to injury, in Texas and other states, schools cannot impose mask mandates, and yet parents can't protect their children from the maskless with the vaccine. Most parents have no choice but to send their kids to school, fingers crossed. 

​​Parents of kids under twelve are not okay, and the FDA isn't helping. The news that the agency could delay—for months—the approval of the COVID-19 vaccine for children was greeted with collective despair by parents across the country. We have no other reasonable means to protect our kids from the Delta variant, which spreads as easily as chickenpox and causes more severe infections. Yet the FDA and the rest of our society have once again left parents to fend for themselves during a global pandemic.

This is no coincidence: the government seems much more concerned about any injury from the vaccine even if it means that while we wait, a much larger number of children contract long COVID or in the worst cases end up on ventilators or die. Why? Because the government is terrified that anti-vaxxers will use even a small number of bad outcomes from the vaccine as grist for their mill. The FDA's response has been to draw out the regulatory process without scientific basis, keeping parents from saving our kids.

Officially, we are told that our children must assume the risk of the Delta variant so that the prevalence of a vanishingly rare, relatively mild side effect of the vaccine (temporary heart muscle inflammation) can be investigated in a larger sample of children. Unstated is that COVID infection itself causes the very same problem in far greater numbers.

This is all backwards. If adults are allowed to opt out of vaccines and masks, then parents should be allowed to opt in to the vaccine to protect our kids from people spreading the Delta variant. The FDA should do everything in its power to extend downward in age the emergency use authorization (EUA) that exists for the 12-15 age group.

To reasonable concerns about COVID-19 exposure parents are told, patronizingly, to trust  bureaucrats to make these decisions. Yet, CDC director Rochelle Walensky not only initially enabled the broad removal of mask mandates across the country (which the CDC has had to revise), but has also dismissively declared earlier this month that the country is now seeing a "pandemic of the unvaccinated." Forgotten are the immunocompromised and those with no access to the vaccine–like our kids. 

There is no magical transformation that a child's immune system undergoes at age twelve. How is it scientific to bar access to a vaccine that has proven astoundingly safe for adolescents, while the pandemic rages on and the emotional costs of continued isolation pile up?  

We understand that the risks of the vaccine are not fully known. But in light of our laissez-faire social context, parents should get to decide to vaccinate children–right away. 

Even erring on the hyper-conservative side, scientists know that vaccine side effects tend to show up within the first two months after administration or not at all. Pfizer will have this data by September, and the FDA should assure the public now that–barring any extraordinary new information available at that time–it will approve the vaccine immediately no later than that point. 

As part of this, the FDA should withdraw its request for more participants' data. What was good enough for approval before doesn't cease being good enough because a small number of adolescents got temporary heart inflammation. Every week that American children spend in school, especially in states without mask mandates, is a week when countless children will become sick and not a few, chronically so. Some of us will not forget the role the FDA played in that.

Any talk of approval by "mid-winter" must stop. Instead of choosing the appeasement of anti-vaxxers over the safety of our children, the least the government can do at this stage is get out of the way.