Pain and redness at the injection site and mild fatigue are the two most frequent side effects children ages 5-11 are likely to get from the COVID-19 vaccine, according to the U.S. Food and Drug Administration.
The FDA reviewed results from more than 4,600 children in the 5-11 age range who were part of the Pfizer-BioNTech COVID-19 vaccine trial. Of this group, about 3,100 were given the vaccine while the others were given a placebo.
Those who received the vaccine were monitored for side effects for at least two months after they received the second dose.
The most reported side effects, according to the FDA, include:
· Pain where the shot was given
· Muscle pain
· Joint pain
· Swollen lymph nodes
· Decreased appetite
The side effects were typically present within two days of taking the vaccination and lasted around one to three days.
Except for pain at the injection site, most side effects were seen after the second dose of the vaccine. The age group had side effects from the Pfizer vaccine that were similar to those experienced by those ages 16 and older who received it.
The FDA noted that not everyone had side effects from the shot.
Last month, the FDA authorized a lower dose of Pfizer’s vaccine for emergency use in children ages 5 to 11. The CDC approved the Pfizer vaccine for the age group last week.
The FDA noted that it and the CDC’s safety surveillance systems “have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age.
“Therefore, the FDA conducted its own benefit-risk assessment using modelling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children 5 through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause.
“The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age.”
Moderna is in the process of seeking approval of its vaccine for children. Moderna said in late October the FDA needed more time to complete its review of the vaccine in the 12-17 age group while it studies the risk of a type of heart inflammation called myocarditis that some have developed after getting the vaccination.
It has delayed its application for use of the vaccine in children ages 6 to 11 until the FDA finishes that review.
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