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.
PIC appears to have confused serious adverse events with reactogenicity—a general term for inflammation caused by the immune system’s response to a vaccine. This includes vaccine site pain, fever, and headaches, among other events. Such symptoms are graded on a scale of 1 to 4, with 4 being the most severe. Out of 1,131 vaccinated participants in the Pfizer/BioNTech vaccine trial, 121 experienced health events that were categorized as reactogenicity grade 3 or higher. This comes out to 10.7 percent of vaccinated participants, or about 1 in 9 participants.
Since the Pfizer/BioNTech vaccine was approved for children 12 and older in May, serious adverse events have been rare among eligible children who have been vaccinated.
A spokesperson for the Center for Disease Control tells The Dispatch Fact Check via email that “the claim that 1 in 9 adolescents had a severe reaction to a COVID-19 vaccine does not accurately explain reports related to vaccine safety.”
In a Morbidity and Mortality Weekly Report (MMWR), released by the CDC on July 30, researchers reported that “mild local and systemic reactions are common among adolescents following the Pfizer-BioNTech vaccine, and serious adverse events are rare.”
A CDC spokesperson also explained, “out of the 8.9 million U.S. adolescents who received this vaccine, 9 percent of VAERS [Vaccine Adverse Event Reporting System] reports were serious. Out of those, myocarditis, or heart inflammation was listed in just 4 percent of reports.”
For context, VAERS, as described by the CDC, “is the nation’s early warning system that monitors the safety of vaccines after they are authorized or licensed for use by the U.S. Food and Drug Administration (FDA).”
The Dispatch’s Alec Dent has noted previously that “the reports filed through VAERS are not indicative of actual vaccine side effects, they’re simply used as a jumping off point for investigating possible adverse effects. It may turn out that a previously unknown adverse effect is tied to the vaccine in question, though the reported adverse event may turn out to be entirely unrelated to the vaccine. It’s also entirely possible for false reports to be filed with VAERS—Vice shared the story of anesthesiologist James Laidler, who filed a VAERS report claiming a flu shot turned him into the Hulk. Laidler did so to show why unverified reports in VAERS should be taken with a grain of salt.”
The CDC spokesperson also added that less than 1 percent of vaccine recipients ages 12 to 17 needed medical care after vaccination.
Furthermore, according to a peer-reviewed New England Journal of Medicine study published on May 27 of this year, the Pfizer vaccine had a “favorable safety profile” in recipients ages 12 to15.
More specifically, the study found that: “BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86 percent of participants].” The study also noted that: “there were no vaccine-related serious adverse events and few overall severe adverse events.”
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