Comment Submitted to FDA/Advisory Committee on “Authorizing” Use of Pfizer Vaccine in Kids Ages 5-11

As I discussed in the show on Saturday, yesterday I submitted a comment to the FDA about the “Authorization” of Pfizer’s COVID vaccine in kids ages 5-11. It seems that over 139,000 others did the same, and so it will likely be weeks before they will be able to sift through and publish all that! So I may as well share my comment here as well. Note that I wrote my entire comment within the 5,000 character limit, with no attachments, and so I did not use embedded links for the references I included. (It was just a text submission box, for those unfamiliar with the process, as I was. This was a first for me!)

To whom it may concern, including members of the Advisory Committee,

I am not normally the type of person who would weigh in on whether a government agency should *authorize* the use of anything. But in this case, we learned last week that our government has already purchased enough doses to vaccinate the entire population of our country ages 5-11.  This means it’s reasonable to infer that, not only is the “authorization” a forgone conclusion—with this meeting being just a rubber stamp—but also that our government anticipates that every last child in this age range will be vaccinated. (The Hill article also details elaborate plans to “nudge” parents using pediatricians and children’s hospitals.) In other words, what is being contemplated by your committee is not just an “authorization” – an “Emergency Use” authorization at that — but a *mandate*.

Whether an authorization of the use of this vaccine, apart from a mandate, would be appropriate, is a question best left for medical experts. But note that, even in the briefing published here, it is acknowledged both that (1) the reported study included too few participants to rule out significant known side effects—myocarditis and pericarditis, and (2) the long-term side effects of this vaccine are currently unknown for any age group and so much more study is needed to do a proper risk-benefit calculation. Now combine what is acknowledged in this briefing with (1) the common-sense observation that if there are long-term side-effects, the burden of them will fall disproportionately on our children, and (2) the known risk to this age group, from the disease to be vaccinated against, is extremely low.  Furthermore, we know that there are currently studies underway to determine the effect of this vaccine on women’s menstrual cycles, a known side-effect of the vaccine in adult women.  The natural inference from this last is that there may be an impact on girls’ future fertility from this vaccine, and there is no way to rule that out at this time. And because disturbances in males’ reproductive systems often aren’t quite as patent as are those in females, it would probably be worth conducting further investigations as to effects on male fertility as well, even if there have not been many verified complaints yet.

Given all of the above, I would be hesitant to even authorize the use of this vaccine in otherwise healthy children in this age group, much less to grant an “emergency use” authorization. I cannot understand how weighing the risks against the benefits—with the wellbeing of an individual, otherwise healthy child in mind—would result in a decision to vaccinate, especially given that so much is currently and necessarily unknown. 

But what is clear is that the use of this vaccine in young children should not be mandated. And again, while this hearing is stated to be about mere “authorization,” everyone seems to understand that, in this context, for some reason that many of us do not understand, “authorization” will mean a green light to mandate. (Ask Gavin Newsom what his plans are in this regard.) Accordingly, I urge the committee to recommend against authorization, unless any authorization issued clearly and unequivocally states that, while it applies to *voluntary* use of the vaccine in this age group, it strongly recommends against mandates or any government program designed to “nudge” parents to get their otherwise healthy children vaccinated. 

Our children are the most vulnerable minority. And while many in government seem willing to curb online speech in the name of protecting them from harm, just as many seem eager to force them to risk their physical health and wellbeing as part of a scientific experiment, because we adults are afraid of what a virus will do to us. Enough is enough.

1 Comment

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One response to “Comment Submitted to FDA/Advisory Committee on “Authorizing” Use of Pfizer Vaccine in Kids Ages 5-11

  1. Stacey Hoffman

    Wow! Great article. Thanks for all your hard work.

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