The vaccine’s safety was studied in approximately 3,100 children aged 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.

• COVID-19 vaccines were developed using science that has been around for decades.
• COVID-19 vaccines are safe—much safer than getting COVID-19.
• COVID 19-vaccines are effective at preventing severe illness from COVID-19 and limiting the spread of the virus that causes it.

Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.

The vaccine that is authorized for use in children 5 through 11 years of age includes the same mRNA and lipids but different inactive ingredients compared to the vaccine that has been used under EUA in individuals 12 years of age and older.

The use of these different inactive ingredients helps stabilize the vaccine under refrigerated temperatures and the formulation can be readily prepared to deliver appropriate doses to the 5 through 11-year-old population.

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.

The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product.

All these criteria must be met to allow the product to be used in the treatment of patients during the COVID-19 pandemic.

No, there is no evidence that any vaccines, including COVID-19 vaccines, cause fertility or long-term health problems in women or men. Learn more about this and other myths and misunderstandings about the vaccine.

Although fewer children have been infected with COVID-19 compared to adults, children can:

• Be infected with the virus that causes COVID-19
• Get sick from COVID-19, and require hospitalization because of the illness
• Spread COVID-19 to others

In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. Along with the CDC, FDA, and other groups committed to protecting children's health, we strongly recommend that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine.

Tell us about your child’s medical conditions, including whether your child:

• has any allergies
• has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• has a fever
• has a bleeding disorder or is on a blood thinner
• is immunocompromised or is on a medicine that affects your child’s immune system
• has received another COVID-19 vaccine
• has ever fainted in association with an injection

Your child may have some side effects, which are normal signs that their body is building protection. Side-effects vary by person, and may include things such as fever, injection site swelling or redness, feeling unwell, decreased appetite or upset stomach, tiredness, or swollen lymph nodes. These side effects may affect their ability to do daily activities, but these should go away in a few days. Some people have no side effects.

Talk to your doctor about taking over-the-counter medicine, such as ibuprofen, acetaminophen, aspirin, or antihistamines for any pain and discomfort your child may experience after getting vaccinated.

In most cases, discomfort from pain or fever is a normal sign that your child’s body is building protection. Contact your doctor or healthcare provider:

• If the redness or tenderness where your child got the shot gets worse after 24 hours
• If your child’s side effects are worrying you or do not seem to be going away after a few days
• If your child gets a COVID-19 vaccine and you think they might be having a severe allergic reaction after leaving the vaccination site, seek immediate medical care by calling 911.

Learn more about COVID-19 vaccines and rare severe allergic reactions.

The vaccine does not contain SARS-CoV-2 and cannot give your child COVID-19. Therefore, your child will not be contagious and cannot infect anyone else because of the vaccine.

If your child feels well enough to go to school, it is safe and fine for them to continue with regular activities.

You might need to plan for a day to rest in case your child experiences any of the potential side-effects.

• Talk to your child’s pediatrician.
• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
• Contact your local or state public health department.

Your child’s vaccination will be entered into their Kelsey-Seybold Clinic records, which can be viewed in your MyKelsey app or MyKelsey online account. Your child’s COVID-19 vaccination record will also be entered into the Texas Immunization Registry, as required by the state. This helps ensure that your child receives the same vaccine when your child returns for the second dose.

For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.