Pfizer-BioNTech’s COVID-19 vaccine received emergency use authorization (EAU) use in children ages 5 through 11. This move comes weeks after Pfizer submitted its application for EAU consideration. The Federal Drug Administration (FDA) assures parents and guardians this move is based on the agency’s thorough and transparent evaluation of data that included input from the independent advisory committee experts.
After reviewing Pfizer’s study results of children 5 to 11, the Human Drug Advisory Committee overwhelmingly voted to make the COVID-19 vaccine available to kids in this age group.
COVID-19 Vaccination Safety and Effecacy
The study results compared the vaccine’s effectiveness for children ages 5 through 11 and individuals 16-25. Immune responses showed Pfizer-BioNTech’s vaccine was 90.7% effective in the prevention of COVID-19 was compatible. Moreover, the FDA indicates that approximately 3,100 children were vaccinated. In addition, researchers report no serious side effects have been detected in the ongoing study. Therefore, the benefits of the COVID-19 vaccine outweigh the known and potential risks.
Acting FDA Commissioner Janet Woodcock, M.D., explained that as a mother and physician, she knows many people anxiously waited for the agency’s authorization. “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.” She reiterated the comprehensive and rigorous evaluation of the data should ease the minds of parents and guardians about the vaccine meeting the FDA’s high safety and effectiveness standards.
COVID-19 Dosage and Common Side-Effects
Children, ages 5 to 11, will receive a two-dose course of the Pfizer-BioNTech COVID-19 vaccine three weeks apart. The dosage for this age group is 10 micrograms, which is lower than the 30 micrograms dosage prescribed for those 12 and older.
Commonly reported side effects observed during the clinical trial were typical of those seen in other age groups; injection site pain, redness, swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite. A greater number reported side effects after the second shot than after the first. As reported by previous studies, these side effects were commonly mild to moderate in severity and most often occurred about 48 hours after the injection. Typically, most went away within 24-48 hours.
Ongoing COVID-19 Vaccination Safety Monitoring
The FDA and Centers for Disease Prevention and Control (CDC) safety monitoring system previously identified an increased risk of myocarditis and pericarditis after a Pfizer-BioNTech COVID-19 injection, especially after the second dose. Those at the highest risk are males 12 to 17. However, based on the FDA benefit-risk assessment, they determined the benefits outweigh the risks in children 5 to 11.
Pfizer’s safety monitoring plan includes evaluating myocarditis, pericarditis, and other events of interest for this younger age group. Moreover, the FDA and CDC have multiple systems set up to monitor COVID-19 vaccine safety. These systems are also used to detect and investigate potential safety events rapidly.
The FDA mandates Pfizer and other vaccination providers to report any serious adverse events and vaccine administration errors promptly.
Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., announced the agency has posted documents supporting their decision and will post further data soon.
We hope this information helps build the confidence of parents who are deciding whether to have their children vaccinated.
Health experts recently announced it is safe to take both the COVID-19 and influenza vaccinations simultaneously.
COVID-19 vaccinations are free of charge for every eligible individual in the United States regardless of insurance or immigration status.
Written by Cathy Milne-Ware
FDA: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
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