Have ‘1 in 9 Vaccinated Adolescents Suffered a Severe Adverse Reaction’ From the Pfizer Vaccine?

No.

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Update, January 12, 2022: The Physcians for Informed Consent updated its post to describe “severe adverse events” as reactogenicity. We removed our “partly false” rating from the Facebook post.

A viral Facebook post from Physicians for Informed Consent, self-described as a “nonprofit organization focused on science and statistics,” claims that “1 in 9 vaccinated adolescents suffered a severe adverse reaction” from the Pfizer/BioNtech COVID-19 vaccine. 

This is a false claim.

The clinical trial data PIC links to in their Short-Term Efficacy & Safety Data sheet shows not 1 in 9 vaccinated trial participants experiencing serious adverse events, but 5 out of 1,131—or roughly .4 percent of trial participants who received the vaccine. The CDC defines a serious adverse event as “Death, life-threatening event, hospitalization, incapacity to perform normal life functions, medically important event, or congenital anomaly/birth defect.” None of the serious adverse events reported in the clinical trials were determined by the FDA to be related to the study.

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  1. Avatar photo
    Pat @ Tavi Hall

    Math people!: "This comes out to 10.7 percent of vaccinated participants, or about 1 in 9 participants." 10.7% is 1 in 10.

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    BWG

    "None of the serious adverse events reported in the clinical trials were determined by the FDA to be related to the study." Glad to hear, because 1 in 226.2 doesn't make me feel all that much better than 1 in 9.

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    Show Jay Janney the 🚪!

    T"he CDC defines a serious adverse event as “Death, life-threatening event, hospitalization, incapacity to perform normal life functions, medically important event, or congenital anomaly/birth defect.”

    So hollering "𝙊𝙬𝙬𝙬!!!" when you got shot doesn't count? Had they told me that prior to the survey...

    Definitions matter!

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  4. CatoTheElder

    I know of one adolescent who was turned into a newt. But he got better.

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  5. Ingenero.lux

    It’s a bad sign when my first reaction to a nonprofit that says it’s focused on “science and statistics” is to assume it’s focused on something entirely other than actual science or real statistics. And be entirely correct. These days it feels like most new organizations that claim “science” are like used car dealerships with “honest” in their name - expect anything but. What a world.

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    CynthiaW

    Sons D, E, and F got sore arms.

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    1. Avatar photo
      Jake

      When I get a fever of 99, I’m not able to perform normal life functions. Just ask my wife.

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        CynthiaW

        99? Really?

        My mother wouldn't let us stay home from school with a temperature under 101.

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    Picov Andropov

    So sorry you all at the Dispatch have to keep shoveling through this garbage. Thanks for dealing with this flood of misinformation for us.

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    1. JVS

      Wait a minute. Am I reading this correctly? 0.4% of adolescents got a serious medical reaction, defined in the CDC report as "Serious adverse event (SAE) is defined as any untoward medical occurrence that, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or is a congenital anomaly/birth defect” That's one child out of every 250 (1 out of every 226 actually, according to the study). The initial interpretation may have been severely overstated, but if this is the underlying truth, as reported by the CDC itself, that's pretty significant! How many students would that be in an average high school? I'd like to know more before writing the whole thing off as "misinformation."

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        Pat @ Tavi Hall

        If you're working from https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-05-12/03-COVID-Wallace-508.pd, it's worth noting the placebo had 0.2% of these as well.

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          DrBlud

          I agree. That is reassuring. But knowing what the SAEs are in the two arms would be more helpful. Vaccine-associated side effects are rare events (even VITT is 1:1K-5K at most). The seminal approval study was large enough to do a subanalysis of 12-15 yo to query efficacy in the prevention of infection (vaccine is superior to placebo), but not large enough to perform a meaningful statistical analysis about whether a rare life-threatening SAE such as myocarditis or VTE (both reported in post-approval studies) was more common. A back of the hand power calculation suggests about 20K subjects in each arm with safety as the primary endpoint. The challenge for the approving agencies is that the incidence of SAEs due to SARS-CoV-2 infection in individuals 12-15 y is around 1/1K as well. At some age the number needed to treat (NNT) to prevent a SAE due to SARs_CoV-2 may be equivalent to the NNT to have a vaccine-induced SAE. That leaves the regulatory agency in a quandary as they are charged to look at the risk/benefit to the individual, it really might not be there. The benefits to the community are harder to assess.

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        DrBlud

        The nature of the SAE has been described somewhere and may be part of an addendum. I think you question is a good one, but Joe Higashi may be right it could be a hit over the head by a meteor. All must be reported to the sponsor and included in the report. But it's worth looking. At the time the study was being performed (the NEJM article was published in May 2021 so best guess as to subject enrollment would be late 2020 early 2021), the SAE could have been a venous thromboembolism (VTE) or stroke which a local investigator at one site could reasonably state "not related to study drug". How could they have known that VTE/stroke 4 weeks later would be associated with vaccination with a vaccine (see AstraZeneca experience)? That is why all events must be reported but... the "not related to study drug" assessment should be taken with a grain of salt. That is always based on previous experience of the investigator with that class of drugs at the time the SAE occurs so would miss a completely unexpected SAE.

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          DrBlud

          For those who wonder, this is not an "I'm just saying..." argument. Someone who has the time, maybe the fact checker might look this up. I really have no idea what the SAEs were

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      3. Joe Higashi

        "None of the serious adverse events reported in the clinical trials were determined by the FDA to be related to the study." It would be a little interesting to know what happened to the 5 kids that had a problem after the vaccine. It sounds like if a kid got hit by a car after getting the vaccine that would count as an "SAE unrelated to the study."

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