By Chris Kresser, from his newletter

Is this a good idea?

Under the FDA guidelines, a product must meet the following four criteria to obtain an EUA:

  1. There must be an emergency.
  2. A vaccine must be at least 30% to 50% effective.
  3. The known and potential benefits of the product must outweigh the known and potential risks of the product.
  4. There can be no adequate, approved, and available alternative treatments (drugs or vaccines).

The Pfizer vaccine for kids under 5 years old fails on at least three of the four criteria above.

First, as I have documented at length in previous emailsthe risk of hospitalization and death from Covid-19 in kids is extremely low. That is even more true now that the Omicron variant is dominant. And recent reports have shown that as many as 40% of pediatric Covid hospitalizations are “with Covid” rather than “for Covid.” This means that the child was hospitalized for another condition, injury, or infection, but tested positive for Covid on admission. Thus, the risk of Covid in kids this age doesn’t qualify as an emergency, and the first criterion hasn’t been satisfied.

Second, the clinical trial that Pfizer ran last year on their mRNA vaccine in kids 2 to 5 years of age showed that it didn’t work. Pfizer then said that it thought a third dose might be more effective, but so far, that has not been tested. It is merely a theory or a guess, and there are no data whatsoever to support it. Thus, the second criterion hasn’t been satisfied.

Third, we don’t know enough about the potential risks of the Pfizer mRNA vaccine in kids under 5 years of age. Pfizer claimed that “no safety concerns were identified” in their initial trial, but the number of participants was small—they initially enrolled 4,500 young kids, but it’s not clear how many actually participated in the trial. 

I’ve previously shared data from the Centers for Disease Control and Prevention (CDC) suggesting that the risk of an adverse effect from the Covid vaccines in 5- to 11-year-olds may be as high as 1 in 1,104. If the risk of an adverse event is even close to this in kids under 5 years old, it doesn’t make any sense to approve a vaccine in this age group when we have absolutely no evidence of benefit. Thus, the third criterion hasn’t been satisfied.

Finally, we have the question of whether there are adequate, approved, and available alternative treatments. It’s less clear how to answer this question for young children. But to a certain extent, it’s a moot point because the Pfizer vaccine has already failed the first three of the four criteria that need to be met in order for an EUA to be approved. 

Nevertheless, Pfizer has submitted an EUA application, and the FDA will review it on February 15. I cannot for the life of me understand how the FDA can review an EUA application when there are no data on the vaccine’s efficacy to support the application!

This is incredibly disturbing. The FDA seems to be rushing to approve a completely unproven medical treatment for an age group that is at extremely low risk for the disease that product is intended to treat. 

Where is the emergency? Why should this be rushed? We’re talking about the health of our children here—and in this case, the health of our youngest and most vulnerable kids.

If the Pfizer vaccine is approved for kids under 5 years old, most parents will (understandably) assume that it has been shown to be effective and safe. That is not the case. 

Aaron Siri (who has sued the FDA to force it to release the documents it relied on to approve the Pfizer EUA) has been writing about this issue, and I think this paragraph from one of his recent articles sums up the predicament we are in:

“Just look at this circus – the government mandates Pfizer’s product, gives it immunity for any safety or efficacy issues, promotes its product using taxpayer money, gives Pfizer over $17 billion and then uses taxpayers’ money to fight to avoid providing even the most basic level of transparency to the public.”

This is not how science and medicine should work. We need more rigor, more transparency, and more oversight from the federal agencies that are supposed to play this role. 

In health,
Chris

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