The FDA’s inexcusable foot-dragging on child vaccination

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Many American parents are extremely anxious about returning their kids to school amid the resurgent COVID-19 pandemic — which is especially frustrating because the country is swimming in vaccines. Yet instead of scrambling to issue an emergency use authorization so children can get vaccinated, the FDA has asked Pfizer and Moderna to greatly expand the sample size of their clinical trials for children, which will likely push back initial approval by months, into midwinter.

This is unacceptable. The Food and Drug Administration already has data on kids aged between 5-11, and should issue emergency authorization for all children under 12 as soon as possible, so long as that data shows an acceptably low risk of complications. Dithering to understand very rare side effects is simply bad risk management with the Delta variant spreading like wildfire.

The reason the FDA is asking for more data is concerns over rare side effects, myocarditis and pericarditis (types of inflammation of the heart) that were seen in a few young people in Israel and the elsewhere. The worry is that younger kids might be at higher risk due to differences in their immune systems. In the abstract, that makes sense — obviously in ideal conditions one would want the best possible data on what the vaccines do in kids. We should be cautious when approving new treatments for children.

But we are just as obviously not in ideal conditions. The pandemic is absolutely out of control in many southern states, and even in heavily-vaccinated states cases are still rising. Meanwhile, the school year is close to starting or has already started across much of the country, and school districts in many conservative states are in an open battle with their state governments over the right to have even slight protections in the classroom. Texas Governor Greg Abbott and Florida Governor Ron DeSantis are both in court over this question.

Even so, whatever protections schools do set up will likely be inadequate, given how cash-strapped American schools tend to be and the extreme contagiousness of the Delta variant. Sure enough, when schools have started with in-person instruction, instantaneous gigantic outbreaks have commonly been the result. Some 121,000 COVID cases were reported among children last week, and a record 1,900 kids are currently hospitalized. Multiple cities have run out of pediatric ICU beds.

So the FDA is facing a tough choice. The raging pandemic means there is no way to avoid risk: Either approve the vaccine for kids aged 5-11 right away, chancing that a few kids will come down with complications, or sit back and let most of them get COVID. The correct choice will depend on which option causes less harm.

Obviously I am not an expert in the science of what mRNA vaccines might do in kids. But multiple credentialed doctors and epidemiologists have argued that the data the FDA already has is enough to make an educated guess, and that vaccination will almost certainly be far, far safer than COVID. In Israel, the risk of myocarditis was roughly between one in 3000 and one in 6000 for men between 16 and 24 (the highest-risk group), and all but two of them recovered. “Ninety-nine percent of the experts in this area are convinced these vaccines are absolutely safe in children and adults from what we’ve seen,” Dr. Yvonne Maldonado, a Stanford professor of pediatric diseases, told Michelle Goldberg at The New York Times.

Pediatrician Aaron E. Carroll writes that he is confident enough in the vaccines that if his kids were younger, he would have them vaccinated at the earliest possible moment, because COVID is no joke even for kids:

But last fall, as many schools went online or hybrid, it became apparent that while kids were at reduced risk, that risk was real. At least 354 kids have died from COVID-19. Many more thousands have been hospitalized. More than 4,400 have been diagnosed with multisystem inflammatory syndrome in children (MIS-C), a “rare but serious condition associated with COVID-19,” and many more have been ill, even if they’ve recovered pretty well. Although COVID-19 has been nowhere near the danger that it has posed to adults and the elderly, it’s still been worse than most flu seasons for children. [The Atlantic]

The American Academy of Pediatrics wrote an open letter to the FDA making the same argument I have above. “The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort, which are already available, while continuing to follow safety data from the expanded cohort in the post-market setting,” they wrote.

But perhaps the strongest argument for child vaccination has to do with adults and society as a whole. Kids are a big hole in the vaccination wall — there are about 31 million people aged between 5 and 11 years old, or about 10 percent of the population (and another 6 percent between 0-4). Practically speaking, that means it is impossible for even the most-vaccinated states to get up to the 85-90 percent vaccination rate scientists estimate is probably necessary for Delta to die out. Until we can vaccinate kids, the pandemic is going to keep burning for months, even in Vermont.

What’s more, unlike single adults or childless couples, almost all kids live in larger households, which necessarily means greater risk of transmission — particularly with Delta. Sure enough, a recent study found that kids can easily get COVID from school (or other activities) and spread it around their household. To the probable benefits of children avoiding sickness and death must be added the benefits of reduced risk for their family members and friends.

At any rate, while I may not be an epidemiologist, I know bureaucratic rear-covering when I see it. When a microscopic handful of people got a rare blood-clotting side effect as a result of the Johnson & Johnson vaccine, the FDA issued a pause on its use — showing a wildly disproportionate sensitivity towards vaccine-caused illness as compared to that caused by COVID, which is indeed much, much worse.

For whatever reason, bureaucrats often seem to believe that the worst kind of failure is when the government takes some action and bad things happen. Bad things happening because the government didn’t take swift action doesn’t register in the same way. But the truth is that if the FDA has sufficient evidence to know that vaccinating kids will make them and the American people safer on net, and they refuse to do so, they will be directly responsible for a tremendous amount of unnecessary illness and death.


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