CDC and FDA Authorize Pfizer-BioNTech’s COVID-19 Vaccine for Children 5-11 Years of Age

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News Release
 
For Immediate Release: 11/4/2021
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CONTACT
Olga Dack, Office of Communications, 402-840-0711, olga.dack@nebraska.gov  

Lincoln – On Tuesday, November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) of the Center of Disease Control and Prevention (CDC) issued a recommendation for the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11. The CDC announcement follows the Food and Drug Administration (FDA) authorization of the Pfizer-BioNTech COVID-19 Vaccine for emergency use in children 5 through 11 years of age on October 29, 2021. This recommendation applies to all children of age 5 through 11, including those with underlying conditions and previous COVID infection.

The vaccine was found to be 90.7% effective against symptomatic COVID disease. ACIP voted unanimously for the vaccine and stated that the “safety and efficacy data were clear, and that benefits of the vaccine overwhelmingly outweigh the risks of COVID disease."

There are about 28 million children between the ages of 5 and 11 in the U.S. Nearly 2 million cases of COVID-19 have involved children in this age group since the start of the pandemic, and approximately 8,300 (0.4%) of these cases resulted in hospitalization.

Vaccine Administration

The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose series, 3 weeks apart, but at a lower dose (0.2 mL) than the dose used for individuals 12 years of age and older (0.3 mL).

COVID-19 vaccine dosage does not vary by patient weight but by age on the day of vaccination. If a child turns from 11 to 12 years of age in between their first and second dose and receives the pediatric Pfizer-BioNTech COVID-19 Vaccine for their second dose, they do not need to repeat the dose.

Distribution of pediatric vaccinations across the country has already started, and some shipments are expected to arrive in Nebraska this week. Vaccines will be available at pediatric healthcare provider offices, pharmacies, Federally Qualified Health Centers, local health departments, and more.

Vaccine Effectiveness

Compared to adults, children are at a lower risk of becoming severely ill with COVID-19. However, they can be still infected with the virus. Getting your child vaccinated can help protect them against COVID-19.

Data obtained from State Health Information Exchange and Nebraska State Immunization Information System (NESIIS) show that Nebraskans who are not fully vaccinated are 10 times more likely to be hospitalized with COVID-19.

Dr. Matthew Donahue, Nebraska's Acting State Epidemiologist, comments, “Pediatric COVID-19 vaccinations are now available, and parents should be reassured that vaccinations are safe, that they work, and that they are the best way to protect ourselves and our children. We encourage Nebraskans to visit with their doctor about the vaccine."

Parents are encouraged to discuss any questions they may have with their pediatrician, school nurse, or pharmacist to learn more about the vaccine and to make an informed decision about getting their children vaccinated.

Side Effects

The vaccine's safety was studied in approximately 3,100 children ages 5 through 11 who received the vaccine, and no serious side effects, including myocarditis, Bell's palsy, anaphylaxis, or death, were detected. Vaccine recipients were followed for safety for at least 2 months after the second dose.

Side effects occurred within two days of vaccination, were generally mild to moderate in severity, and included soreness at the site, headaches, muscle aches and low-grade fevers, fatigue, nausea, and decreased appetite, which are common in the adult population. More side effects were reported after the second dose than after the first dose. These side effects are normal signs that the body is building protection, and most of them should go away within a day or two.

Cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) have been reported following vaccination of children ages 12 through 17 years of age. These reactions are rare; in one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12–17 years. In general, people who developed these conditions following COVID-19 vaccination responded well to medical treatment and rest and recovered.

Serious side effects are rare, but may occur. Parents/caregivers may enroll their children in v-safe, a free, smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins. Through v-safe, parents can report how their child is feeling after being vaccinated.

Ongoing Safety Monitoring

Pfizer Inc. has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children 5 through 11 years of age. In addition, the FDA and the CDC will continue to monitor COVID-19 vaccine safety and investigate potential safety problems.

Additionally, patients, caregivers, and vaccine providers are also asked to report adverse events after vaccination to the Vaccine Adverse Event Reporting System (VAERS), even if it is not clear that the vaccine caused the adverse event. CDC reviews all of the information and reports any serious adverse reactions.

DHHS continues to share new information via the Coronavirus website, as well as Facebook and Twitter. For more information about vaccinations or how to get vaccinated, talk to your healthcare provider or visit the COVID-19 Vaccine Information page.

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