Study by German researchers didn’t find significant safety concerns with Pfizer-BioNTech COVID-19 vaccine, contrary to claim by Alex Berenson
The American Academy of Pediatricians recommends that all eligible infants, children, and adolescents six months and older be vaccinated against COVID-19. Although the U.S. Advisory Committee on Immunization Practices (ACIP) voted to add the COVID-19 vaccine to the childhood immunization schedule, this addition doesn’t make the vaccine mandatory for attending schools. Whether a vaccine is mandatory to attend school is up to states.
Misleading: The study reported that children younger than five were more likely to experience an adverse event after receiving the Pfizer-BioNTech COVID-19 vaccine compared to non-COVID-19 vaccines. However, the vast majority of these were mild and short-lived.
Misrepresents source: The researchers collected survey results of post-vaccination adverse events. However, they didn’t have enough information to attribute the adverse events to the vaccine. Characterizing these adverse events as “vaccine injury” is inaccurate.
The claim that German researchers found the COVID-19 mRNA vaccines to cause more side effects in young children began circulating in October 2022. Journalist Alex Berenson made this claim in a Substack post and an Instagram post, while Will Jones, who holds a PhD in political philosophy and writes for the website The Daily Sceptic, reported on the study in a similar manner, claiming that “One in every 500 children under five years who received the Pfizer mRNA Covid vaccine were hospitalised with a vaccine injury”.
The study cited in both articles was published in the journal JAMA Network Open on 18 October 2022. Performed by researchers in Germany, the study gathered survey responses by guardians of children younger than five regarding post-vaccination symptoms after the Pfizer-BioNTech COVID-19 vaccine.
All in all, the study included 7,806 children who had received at least one dose of the vaccine. The dose administered differed among children, from three, five, and ten micrograms. It’s important to note that the use of the vaccine in these children is off-label. The vaccine is currently only approved for use in children aged five and above in Germany, but parents may decide to seek vaccination for their child even if the child is not of age yet.
The researchers reported that ten of the children required hospitalization at some point after vaccination; all ten had received either five or ten-microgram doses of the COVID-19 vaccine. Importantly, the researchers noted that none of the children who had received a three-microgram dose—the approved dosage for the Pfizer-BioNTech COVID-19 mRNA vaccine in the U.S. and Canada for children under five—required hospitalization.
The researchers also found that certain types of vaccine adverse events occurred significantly more often after the Pfizer-BioNTech COVID-19 vaccine as compared to non-COVID-19 vaccines, such as local injection site reactions, as well as otolaryngological and musculoskeletal symptoms.
Conversely, other types of adverse events, such as general symptoms and fever, were less likely to occur with the Pfizer-BioNTech COVID-19 vaccine compared to non-COVID-19 vaccines. No cases of myocarditis were reported. There were also no deaths.
Based on the supplemental information included in the study, the most frequently reported musculoskeletal symptoms were muscle pain (ranging from 16 to 20 percent) and pain in the arms (ranging from 34 to 42 percent). The most frequent otolaryngological symptom was swollen lymph nodes (21 to 22 percent).
The portrayal of the study as evidence that the COVID-19 mRNA vaccines are dangerous, as given by Berenson and the Daily Sceptic, is at odds with the researchers’ findings and conclusions:
“In this study, the overall frequency of adverse events after vaccination with BNT162b2 was comparable with the frequency of adverse events after vaccination with approved non–SARS-CoV-2 vaccines in children younger than 5 years.”
Moreover, the methods of the study impose limitations on the conclusions that can be drawn from the study.
Specifically, the study was based on a survey of vaccine adverse events. These are undesirable medical events that occur after vaccination, but may not necessarily be related to the vaccine. In order to determine whether the vaccine was a likely cause of the adverse event, one needs to rely on more than just a temporal association, as Health Feedback explained in a previous Insight article.
As such, the Daily Sceptic’s use of the term “vaccine injury”—which attributes the cause of the adverse events to the vaccine—to describe the adverse events reported misrepresented the study.
In addition, the authors also stated that “no medical records data were accessed for this study”, meaning that the authors didn’t know about the children’s medical history. This is important since the adverse event following vaccination could have been explained by pre-existing conditions or some other condition that happened to develop after vaccination. Indeed, of the ten children who were hospitalized, six had comorbidities, while two were on long-term medication.
A table in the study presenting the characteristics of children who required hospitalization. Note that six of the ten had comorbidities, while two were on long-term medication.
Without such information, it’s difficult to understand if the vaccine contributed to the adverse event or if it could have been coincidental. In any event, the data didn’t show significant safety concerns.
Currently, most data regarding the COVID-19 vaccines have been derived from adolescent and adult populations, and there is comparatively little data regarding children younger than five. But studies in older children haven’t found significant problems with safety.
A study by the U.S. Centers for Disease Control and Prevention (CDC) in children aged five to 11, which used data from the Vaccine Adverse Event Reporting System and V-safe, found that the vast majority of adverse events (about 97 percent) reported after COVID-19 vaccination were mild and brief. The most common adverse events were injection site pain, fatigue, and headache.
Apart from the reassuring safety profile, clinical trials in children aged five to 11 found that the Pfizer-BioNTech COVID-19 vaccine had 90.7% efficacy at reducing the risk of COVID-19; no vaccine-related serious adverse events were reported.
The American Academy of Pediatricians recommends that all infants, children, and adolescents six months and older who are eligible be vaccinated against COVID-19.
This claim, casting doubt over the safety of the COVID-19 vaccine in children, arose against the backdrop of a meeting by the U.S. Advisory Committee on Immunization Practices (ACIP) to discuss the addition of the COVID-19 vaccine to children’s immunization schedule. Members of the ACIP voted unanimously for the addition on 20 October 2022.
Some, like Tucker Carlson, claimed that this would mean the COVID-19 vaccine would be mandatory for children to attend school.
But this is false. Nirav Shah, an ACIP member and Director of Maine’s Center for Disease Control and Prevention, told Reuters that “Adding the COVID-19 vaccine to the recommended childhood immunization schedule does not constitute a requirement that any child receive the vaccine”.
Indeed, the seasonal flu vaccine and HPV vaccine are also part of the child immunization schedule in the U.S., but they haven’t been made mandatory for attending school throughout the U.S. Whether a vaccine is mandatory for attending school is up to states to decide, as the CDC stated here.
- 1 – Toepfner et al. (2022) Comparative Safety of the BNT162b2 Messenger RNA COVID-19 Vaccine vs Other Approved Vaccines in Children Younger Than 5 Years. JAMA Network Open.
- 2 – Hause et al. (2021) COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021. Mortality and Morbidity Weekly.
- 3 – Walter et al. (2022) Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. New England Journal of Medicine.