After months of clinical trials and thousands of patients participating in research, the Centers for Disease Control and Prevention (CDC) expanded emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to be administered to children ages 5-11 as a two-dose vaccine series and a booster dose.
The initial two-dose regimen for this age group was approved in November 2021; the booster dose was approved in May 2022.
Pediatrician Steven Schulz, MD, and Pediatric Infectious Disease and Immunology specialist Michael Pichichero, MD,who has been involved in development and testing of more than a dozen pediatric and adult vaccines, are two physicians in the greater Rochester area who have a thorough understanding the vaccine and the process that led to its EUA approval – both in children and adults.
The FDA and CDC reviewed clinical trial data and consulted experts in pediatrics, pediatric infectious disease, pediatric immunology and other specializations before issuing emergency use authorization for children ages 5-11.
First, thousands of parents volunteered their children for clinical trials. Once the trials ended, researchers gathered the data and submitted it to the FDA and CDC for review.
“The same thorough review process occurred for this age group as it did for adult and older child approval. There were no shortcuts,” Dr. Pichichero said.
Expert panels of the FDA and the CDC independently studied the FDA report and recommended approval of the vaccine for emergency use authorization at the FDA and universal recommendation for use at the CDC in the 5-11 year old age group.
The Pfizer mRNA vaccine is the same for both adults and children. The difference is the amount in the dose. A child in the 5-11 age group will receive a dose 1/3 the amount in an adult dose.
Choosing the 1/3 dose size was based on the average weight of a 5-11 year old child in the U.S. and comparing it to the average weight of an adult in the U.S.
Both the adult and child doses of the vaccine were found to be more than 90 percent effective in preventing symptomatic COVID-19 during the clinical trials.
Every child will need two doses just like adults and older children. Those doses will be administered three weeks apart.
This protection guidance is the same as adults and older children. Two weeks after a 5-11 year old child receives their second dose, they will be considered fully vaccinated against the COVID-19 virus.
Five to 11-year-old children in the clinical trials experienced similar side effects to adults and older children who received their dose of the vaccine.
Some of those side effects, similar to a flu vaccine, include:
The side effects last 24-72 hours in most cases.
In rare cases among older children and young adults, mostly among males, transient, self-resolving inflammation of heart muscle called myocarditis has been observed. No 5-11 year old child developed myocarditis during the test of the Pfizer vaccine. However, since fewer than 5,000 children enrolled in the study and the myocarditis side effect occurs in 1 in 125,000, it was not possible to exclude the possibility of the rare side effect from the clinical trial data.
A recent study in the U.K. found patients have a nearly 40 times greater risk of getting myocarditis from a COVID-19 infection than from the vaccine.
Researchers conducting the Pfizer vaccine trials in this age group found the risk of developing myocarditis in adults and older children is extremely rare – roughly a 1 in 125,000 chance. For comparison, the risk of dying from a lightning strike is 1 in 125,000 and in a car crash is approximately 1 in 100.
“The bigger risk is for schools, education, and the teachers,” Dr. Pichichero said. “Five to 11-year-olds need to be in school to learn well. The teachers are worried about their continued exposure. We are in a mental health crisis and children being back in schools is a way to remediate that.”
Estimates suggest as many as 40 percent of kids in the 5-11 age group have already had COVID-19. Some of these children experienced symptoms; others showed no symptoms.
Either way, when your body’s immune system responds to an infection, it produces an immune response. Sometimes those levels of immunity are strong; other times the levels of immunity are lower. Often, the simplest way to determine a person’s level of immunity is to see if they become infected again.
Choosing to get the vaccine is an added insurance policy against becoming re-infected.
“From a public health standpoint, getting 28 million more Americans vaccinated is going to have a big benefit for reducing the likelihood of variants like the Delta variant and other variants emerging and partially escaping the vaccines,” Dr. Schulz said.
On May 19, 2022, the CDC announced children ages 5-11 are now eligible for a booster dose of the COVID-19 vaccine. The booster dose can be administered five months after the initial two-dose regimen.
Rochester Regional Health offers the lower 5-11 year old doses of COVID-19 vaccine at nearly all Pediatric and Family Medicine offices across Western New York and the Finger Lakes.
Patients can contact their provider and schedule a vaccine appointment.
Researchers and clinicians at Rochester Regional Health continue to learn and understand how infectious diseases such as COVID-19 can best be prevented and treated.Review The Facts
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