The Atlantic is running an opinion piece today. suggesting that parents ramp up pressure on the FDA:
Parents of America, Unite!
I think that has no chance of working at this stage, but some other portions are interesting to me...
President Joe Biden has offered little explanation as to why so many must wait. “We can’t take shortcuts with that scientific work,” he said last week. But after telling the public nothing of what the delay was, he assured the audience, the “nation’s top doctors are committed to keeping the public at large updated on the process.” And this past weekend, a little news did slip out: Pfizer expects to submit its data from its trials on 5-to-11-year-olds “in the coming weeks.” But that information is still not not detailed enough, and that timeline is still not soon enough. ACT UP had it right years ago: The FDA doesn’t know how to respond to a crisis, but citizens can pressure it to do what’s right.
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The opponents cited reports of a few cases of a side effect—myocarditis, the inflammation of the heart muscle—in young men. Rare, transitory, and usually not fatal—and anyway what was the rush to vaccinate children?
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A Birmingham, Alabama, pediatric infectious-disease specialist, David Kimberlin, appearing on the former Biden senior adviser Andy Slavitt’s podcast on August 30, revealed more. “Here’s the problem: The few additional subjects are not going to tell you anything at all about rare side effects,” he said. “We are not likely at all to learn anything from an additional thousand subjects enrolled in terms of any rare side effects which may or may not be there … You need an additional hundred thousand to see that, and that’s not a desirable sample size … I personally would not have introduced the additional subjects. The original design was adequate.”
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Parents, too, can both protest and embrace science. ACT UP showed the world that the FDA isn’t the only arbiter of “the science” and that its dilatory procedures cannot be defended simply by invoking the word science. Schools all over America are open. Pediatricians are begging for action. If the FDA wants the parents of American children to wait for its bureaucracy, maybe as long as three more months, it must offer a better reason. And if it can’t, then give us the vaccines already.
I don't have the expertise to know whether this expanded trial is really so useless in determining incidence of rare side effects (though intuitively it would seem to make sense, since even the expanded trial is very small). But if that's true? This delay seems like a terrible mistake given the Delta surge we're currently expriencing.