In a CDC survey of over 13,000 children, more than 55 percent of the subjects between the ages of 6 months and two years had a “systemic reaction” in response to their first dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines, the CDC said on Sept. 1.
A systemic reaction is a response beyond the injection site. The CDC said almost 60 percent had a systemic reaction to the second dose of the Moderna vaccine.
While the most common systemic reactions were fatigue, fever, irritability, and crying, parents of more than 6 percent of the children in the study said their child was unable to perform normal activities after the second dose of either the Pfizer-BioNTech or Moderna vaccine.
The CDC collected the data through a program called V-Safe—a smartphone-based monitoring system that operates through an app that parents download to their phones.
Between June 18 and Aug. 21, parents of more than 10,000 young children reported reactions to the CDC through V-Safe in the seven days after their child received a COVID-19 vaccination.
Parents of 8,338 children ages six months to 2 years who received the Moderna vaccine reported information through V-Safe, with 55.7 percent reporting a systemic reaction after the first dose and about 58 percent after the second dose. For the Pfizer vaccine, parents of 4,749 children ages six months to 2 years submitted reports showing that 55.8 percent had a systemic reaction after the first dose and about 47 percent after the second dose of the vaccine.
The most frequently reported reactions for children six months to 2 years were irritability or crying, sleepiness, and fever. The most common reactions for children aged 3-5 years were injection site pain, fatigue, and fever.
The data also showed a more serious reaction category labeled “any health impact.”
About 10 percent of all children six months to 2 years were reported to have a “health impact” after getting their first dose of either the Moderna or Pfizer vaccine. For the Moderna vaccine, slightly more children had a health impact after the second dose; for the Pfizer vaccine, it was slightly less.
The information was presented to the CDC’s Advisory Committee on Immunization Practices (ACIP) on Sept. 1 as part of an overview of all data related to the safety of COVID-19 vaccines.
In addition to V-Safe, data was presented summarizing reports from the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Data Link (VSD), which includes data from several large health maintenance organizations in the United States.
All three systems look at the safety of vaccines after they’ve already gone to market and have been administered to large numbers of people.
Tom Shimabukuro, the head of the CDC’s vaccine safety team, headed the presentation and told committee members that no “statistical signals” of COVID-19 vaccine reactions were found for young children in the VSD data.
Shimabukuro also said that systemic reactions were “commonly reported” following vaccines.
However, other medical professionals like Dr. Meryl Nass from Children’s Health Defense have expressed caution over the reported reactions, pointing to the high number of systemic reaction reports among very young children.
The FDA approved the emergency-use authorization of COVID-19 vaccines for children aged six months to 5 years on June 17. According to the CDC, about 599,460 children in this age group have received the Pfizer-BioNTech vaccine, and about 440,770 have received the Moderna vaccine.
From June 18 through Aug. 31, approximately 1 million doses of the Moderna and Pfizer vaccines were administered to children in this age group.
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