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The FDA Briefing On Vaccines for Young Children

By November 1, 2021Commentary

I mentioned these materials before, and they can be found here for parents who want to do a thorough investigation before making a decision about getting younger kids vaccinated.  (FDA Materials)

I have also noted that the advisory committee and subsequently the FDA, are recommending use in this age group with completely inadequate data on safety, which is extremely important because there also is essentially no evidence of benefit, given the incredibly low background rates of serious disease in this group.  I would encourage you to read this Twitter thread from a physician to get a better understanding of the issues.  (Twitter thread)

As noted in that thread, several problems exist with the FDA’s safety analysis.  They build a model which used a selective time frame to compare hospitalizations related to CV-19 with those from only one adverse vaccine event–myocarditis.  That time frame was during the peak of a CV-19 wave, not averaged over the epidemic, so it exaggerates the risk of CV-19 hospitalization.  And why is the FDA ignoring hospitalizations from other adverse events?  If you look at slide 2 in this presentation, you see how the FDA set up the analysis in such a limited manner.  (FDA Slides)   If you continue on through that specific presentation you can see how different scenarios were modeled and the assumptions used.  Please note that by now absurd assumption that vaccine effectiveness remains constant over a six-month period.  It doesn’t.  If you continue on through the presentation, you will see that even under these overly-favorable assumptions tilted toward vaccination, there is little benefit from vaccination and in fact in at least one scenario there is greater risk of hospitalization from an adverse event than from CV-19.

And this presentation from the inestimable CDC covers the supposed disease effects in young children from CV-19. I just want to note that any estimates of hospitalizations and deaths in this group are grossly excessive, as they have very high rates of merely incidental positive tests.  The CDC, of course, is not going to tell us that.  And because they so often are asymptomatic, cases are far higher than reported among this group, so true rates of hospitalization and death are much lower.  And you can see that even as reported, there is basically zero risk to children from CV-19.     (FDA Slides)

The CDC can’t ever give up its habit, like the Minnesota DOH, of using statistics to lie.  Note on slide 4 how they claim the proportion of cases among this young 5 to 11 age group is rising, but make absolutely zero adjustment for the fact that the older age groups all are vaccinated to some degree, and many to a very high degree.  There is no actual rise in the proportion of 5 to 11 cases.

Also note on slide 6 the estimate that at least 42% of children 5 to 11 have already been infected.  If that is true, then what is the point of vaccination, either in general in this group or certainly in any who have been infected.  The risk of the vaccine to this group of previously infected children far, far exceeds any benefit to them.  

You can see on that slide 6 as well, that children have a far greater ratio of undetected to detected cases than do adults, again indicating that most cases in this group are mild.

Slide 8 (forgive me if I screw up on numbering, the slides aren’t numbered I am counting), you will see that this age group among children has the lowest hospitalization rates, and what CDC doesn’t tell you is that many of these, especially recently, are for RSV with only incidental positive tests.

Slide 10, hmmm, note that flu hospitalizations were always much higher than CV-19 hospitalizations in children and that any CV-19 hospitalizations during the epidemic were completely substitutive for flu.  And again the recent rise in rates is an illusion caused largely by actual RSV cases, not CV-19.

On slide 12, healthy children are not getting severely ill and don’t get hospitalized from CV-19.

Slide 14, ooops, they really didn’t mean to show us this.  No difference in hospitalizations and outcomes during Delta than before Delta.  Note zero deaths during Delta phase.

Ahhh, my favorite slide, 16, look at the comparative rates of death.  CV-19 is far less risky to children than many other things, and note that it is referred to as “covid-19 associated deaths”.  That “associated” is telling, because most deaths in this age group are not caused by CV-19, but just children who had incidental tests.

Nobody in their right mind, which leaves out the CDC staff, the current administration in toto, as exemplified by our nominal Senilist-in-Chief, and most of the public health community, would think there is any risk to children from CV-19.  So why do they need to be vaccinated?

Ohhh, I forgot the most important thing, they need to be vaccinated to protect the teachers’ union, since it gives hundreds of millions of dollars to our corrupt, senile, incompetent leader’s political party.

Join the discussion 9 Comments

  • Susan A says:

    Kevin thank you for all your efforts to present clear and accurate information on this site. Your work is very much appreciated! While I totally agree with the position that parents should have as much information as possible in order to make an informed decision about vaccinating their children for Covid, the amount of pressure to do so is almost overwhelming. My girls are are in the older age group and from the day approval was given, I was told repeatedly by family, friends, schools, doctors, my workplace (I work for a public health agency in a large NE state), that there was no reason to hesitate and they should be protected. I was only able to resist until late summer and the start of school. Now my son (age 10) will be subjected to this and I am already dreading going through it again.
    I am not anti-vaccine – my kids are up to date on all childhood vaccinations and I received the covid vaccine myself. I just want to be able to wait and see how everything plays out, especially for kids. This issue has gotten so twisted and irrational that I don’t know how we as a society will ever make it through.
    Please keep fighting the good fight – we need a voice of rationality and sanity!

    • Kevin Roche says:

      I think what you are experiencing is the dilemma many parents face, they aren’t anti-vax, but why do children need this one, which does have safety issues

  • Abhijit Bakshi says:

    For me the term “public health” triggers the same reaction as the terms “expert” and “misinformation”: the urge to vomit.

  • shannon iacovino says:

    Kevin you are doing an awesome job. Keep up the good work. Glad you survived your booster. I have read your posts every day for the last year plus.

  • Wendy says:

    As I was awake last night with one of my kids (he has a cold) I was listening to the cough which is a normal cough I was thinking about the rise in RSV cases, and it made me realize that it is very possible that we will see a rise on croup as well. The kids’ immune systems are not be exercised as they should be and I fear that croup will be conflated with COVID and drive the paranoia-porn and will be one of the unintended consequences of these awful COVID policies in relation to kids.

    After reading the FDA took the cowards way out as expected, I am not looking at online schools for my kids. The mask policy is horrendous, and it is a vaccine mandate the state just refuses to call it what it is. The mask mandate states that you can remove masks when your school building (not district but it is build by building policy) when 80% (combined students and staff) are vaccinated and only the vaccinated can remove masks, if that isn’t a vaccine mandate I don’t know what is. And they just pushed the mask policy to AT LEAST Jan 15, 2022 sure that is being litigated but I need to start looking at options for moving my kids in January, I cannot trust the legal system.

  • Tim says:

    So far, 1.9M cases in a population of 52.7M => 3.6% have gotten sick w/COVID
    of those 1.9M, ~8,300 have been hospitalized => 0.44% of cases
    summary slide states “Children 5-11 years of age are at risk of severe illness from COVID-19” which is technically true I guess because EVERYONE is at risk – the issue is that the level of risk for severe illness would seem to be very, very small for the young.
    I just don’t see the justification for mandating vax in this population

  • Wendy says:

    Correction to my post above, I should have has I am NOW looking at online learning (public ‘cyber schools’) for my children or sending them to a private school out of the state in NH rather than keeping them in MA public schools. The NH option is a mere 20 minute drive which is not much longer than my child’s current bus ride, plus he won’t have to wear a mask.

  • Debbie M says:

    Here’s another look at the FDA’s fraudulent data to vaccinate 5-11yr olds.

    Tim, not only do I agree there’s no justification for a vax mandate in this population, I would add there’s no justification to mandate anyone for the vaccine. Offer it to the most vulnerable but no mandates.

    And Wendy, your story saddens me. Maybe there’s a charter in your area that won’t follow suit on the mask mandates. I can feel the despair in your post. What are we doing to our little children??

    The world has done lost it’s mind…

  • Wendy says:

    Debbie thank you, I range between despair, rage, and frustration. There are some like me but I also know that many are afraid to speak and it for some it is simply is not feasible to home school or send to private school so I continue to fight for reasonable policies that make sense because in the long run it will be easier to keep my kids where they are. I am fighting for those that have told me they agree with me but they are afraid to speak up. I am hoping the the newest election results encourage more to speak up.

    Any school in MA public or private is bowing down to the state mandates, even the Catholic schools. However just over the border in NH is a different story all together in both public and Catholic schools.

    In the mean time I am watching the legal battle the first hearing was last week here in MA challenging the State Mandate which is based on exigent circumstances, that they fail to define other than “COVID”.

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