On October 29, 2021, the US Food and Drug Administration (FDA) extended the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for children five through 11 years of age. Up until that point, the FDA had authorized use of the vaccine for emergency use for children from 12 years of age. The FDA announced the newest authorization, basing their recommendation on an evaluation of data collected from an independent advisory committee; that committee voted in favor of making the vaccine available to children under 12 years old, though at a lower dose.
In an effort to clarify information regarding use of the vaccine in children for parents and other caregivers, the FDA offers details regarding the safety and effectiveness as they have assessed it. The pediatric COVID-19 vaccine’s safety is currently being studied. Though the study is ongoing so that more data can be collected, at the time of the FDA’s decision to authorize emergency use of the vaccine, no serious side effects had been detected in the approximately 3,100 children aged 5 through 11 years who were given the vaccine and observed for a short period. And as for the effectiveness of the pediatric vaccine, the FDA says the data shows immune responses of the children in the study were comparable to those of individuals aged 16 through 25 years who were included in earlier studies, with the vaccine being found to be over 90% effective in preventing COVID-19 in children 5 through 11.
Upon the FDA’s emergency use authorization of the Pfizer-BioNTech pediatric COVID-19 Vaccine, the Centers for Disease Control and Prevention’s (CDC) chose to recommend that children between the ages of 5 and 11 years receive it. They argue that while the symptoms of COVID-19 tend to be milder in children as compared with adults, the possibility of illness and/or hospitalization of infected children is a key reason for the recommendation, noting that in some situations, complications from infection can lead to death.
The CDC notes that children ages 5 through 11 years who receive the vaccine will be administered a dose that is one-third of the adult dose of Pfizer-BioNTech COVID-19 vaccine, as authorized by the FDA; a 10-microgram dose of Pfizer’s vaccine is being made available for children in this age group, which is lower than the 30 microgram dose authorized for emergency use for children age 12 and older.
The pediatric COVID-19 Vaccine for children 5 through 11 years of age is authorized to be administered as a two-dose primary series, 3 weeks apart. The CDC states that children in this age group can get the pediatric COVID-19 vaccine at the same time as receiving other vaccines, including the flu vaccine; they also note that the vaccine dosage is not administered based on the weight of a patient, but rather according to the age of the patient on the day of vaccination.
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
COVID-19 Vaccines for Children and Teens
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