8 Things to Know About Vaccinating Your 12 to 15-Year-Old Against COVID-19

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The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent COVID-19 for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the emergency declaration unless ended sooner. Please see EUA Fact Sheet at www.cvdvaccine-us.com/recipients

The Pfizer-BioNTech COVID-19 Vaccine is available for individuals 12 years of age and older.

Researchers have been studying the safety and efficacy of COVID-19 vaccines in adolescents 12 to 15 years old, and on May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded their Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include use in adolescents 12 to 15 years old.

Here are answers to eight common questions about COVID-19 vaccination for adolescents:

1. How many 12- to 15-year-old adolescents are enrolled in the Pfizer-BioNTech COVID-19 Vaccine trial?

The clinical trial for the Pfizer-BioNTech COVID-19 Vaccine enrolled 2,260 adolescents aged 12 to 15 years in the United States.1 Participants are nearly equally divided between male and female. Approximately 15 percent have racially diverse backgrounds.¹

2. What were the results of the clinical study?

None of the 1,131 adolescents who received the vaccine developed COVID-19, while 18 cases of COVID-19 were observed in the placebo group of 1,129 adolescents.¹

According to the CDC, some vaccinated people may eventually develop COVID-19.² “Breakthrough infections” — defined by the Centers for Disease Control and Prevention (CDC) as “development of a disease despite a person’s having responded to a vaccine” — have been noted in some adults who have been fully vaccinated for COVID-19. If you get COVID-19 after vaccination, your symptoms might be less severe.^2,3 The CDC is currently investigating all breakthrough COVID-19 cases.²

3. What should I mention to my child’s vaccination provider before getting vaccinated?

If your child has a known history of allergic reactions, such as anaphylaxis, discuss this with your child’s healthcare provider before making your appointment.

Tell the vaccination provider about all of your child’s medical conditions, including any allergies, if they have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart), if they have a fever, a bleeding disorder or are on a blood thinner, are immunocompromised or are on a medicine that affects the immune system, are pregnant, plan to become pregnant, are breastfeeding, have received another COVID-19 vaccine, or have ever fainted in association with an injection.

4. Is the dosage the same as it was for adults?

Yes, the vaccine dosage for adolescents is the same as for adults. The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart.¹

5. What are the risks of the Pfizer-BioNTech COVID-19 Vaccine?

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

Difficulty breathing
Swelling of your face and throat
A fast heartbeat
A bad rash all over your body
Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the Pfizer-BioNTech COVID-19 Vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the Pfizer-BioNTech COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the Pfizer-BioNTech COVID-19 Vaccine:

Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include:

severe allergic reactions
non-severe allergic reactions such as rash, itching, hives, or swelling of the face
myocarditis (inflammation of the heart muscle)
pericarditis (inflammation of the lining outside the heart)
injection site pain
tiredness
headache
muscle pain
chills
joint pain
fever
injection site swelling
injection site redness
nausea
feeling unwell
swollen lymph nodes (lymphadenopathy)
diarrhea
vomiting
arm pain

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.

If you have questions, talk to your child’s doctor or vaccination provider.

6. What more does the CDC say about mRNA COVID-19 vaccination and myocarditis and pericarditis?

The CDC has published guidance on “Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination.” The CDC continues to recommend COVID-19 vaccination for eligible individuals aged 12 and older, “given the risk of COVID-19 illness and related, possibly severe complications such as long-term health problems, hospitalizations and even death … If you have concerns about COVID-19 vaccination, talk with your or your child’s doctor, nurse, or clinic.” ⁴

If you have a history of myocarditis or pericarditis, tell your healthcare provider before getting the Pfizer-BioNTech COVID-19 Vaccine.

7. How long will the COVID-19 vaccination last for my 12- to 15-year-old?

To date, no one knows how long vaccine-conferred protection will last in adolescents or adults. Researchers plan to monitor adolescent clinical trial participants for two years after vaccination to assess long-term safety and protection.⁵

8. Will schools require COVID-19 vaccinations?

Many schools require proof of vaccination (or vaccine exemption) for diseases such as measles and whooping cough. Vaccine requirements for school attendance are established by state governments. ⁶

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION

FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 12 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.

You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:

had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine

Tell the vaccination provider about all of your medical conditions, including if you:
have any allergies

have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection

Side Effects:

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction
- A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination
- Signs of a severe allergic reaction can include difficulty breathing, swelling of your face and throat, a fast heartbeat, a bad rash all over your body, dizziness, and weakness
- If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
- chest pain
- shortness of breath
- feelings of having a fast-beating, fluttering, or pounding heart
- severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

For the most recent Fact Sheet, please see www.cvdvaccine-us.com/recipients.

REFERENCES

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