Booster Doses of the Vaccine Are Authorized for Persons Who Meet the Guidelines Below
First Booster Dose Available:
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To individuals 12 years of age and older who have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) -
To individuals 18 years of age and older who have completed primary vaccination with another FDA-authorized or FDA-approved
COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
Second Booster Dose Available:
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To individuals 50 years of age and older who have received a first booster dose of any FDA-authorized or FDA-approved
COVID-19 vaccine -
To individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any FDA-authorized or FDA-approved
COVID-19 vaccine
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID‑19) in either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
What you need to know about the vaccine
Frequently Asked Questions
What Is Emergency Use Authorization?
According to the FDA, “During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.”
Getting Your Booster Doses
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Tell the vaccination provider about all of your medical conditions, including if you:
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have any allergies
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have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
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have a fever
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have a bleeding disorder or are on a blood thinner
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are immunocompromised or are on a medicine that affects your immune system
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are pregnant or plan to become pregnant
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are breastfeeding
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have received another
COVID-19 vaccine -
have ever fainted in association with an injection
A first booster dose of the vaccine may be administered after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® to individuals 12 years of age and older.
A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed a primary vaccination series with another FDA-authorized or FDA-approved COVID-19 vaccine.
A second booster dose may be administered to individuals 50 years of age and older, or to individuals 12 years of age and older with certain kinds of immunocompromise, who have received a first booster dose of any FDA-authorized or FDA-approved COVID-19 vaccine.
Individuals should check with their healthcare provider regarding timing of their booster dose.
A first booster dose of the vaccine may be administered at least 5 months after completion of a primary vaccination series of the vaccine to individuals 12 years of age and older.
A second booster dose of the vaccine may be administered to individuals 50 years of age and older, or to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any FDA-authorized or FDA-approved COVID-19 vaccine.
Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine First Booster in Immunocompromised
The CDC has provided guidance that differs from the above FDA-authorized first booster interval for individuals 12 years of age and older who are immunocompromised. The CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for healthcare professionals recommends that a first booster dose of an mRNA COVID-19 vaccine be given at least 3 months after completion of a third primary series dose for people 12 years of age and older who are moderately or severely immunocompromised.
Your healthcare or vaccination provider will help you decide the timing of your first booster dose that is right for you.
A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed a primary vaccination series with another FDA-authorized or FDA-approved COVID-19 vaccine.
A second booster dose may be administered to individuals 50 years of age and older, or to individuals 12 years of age and older with certain kinds of immunocompromise, who have received a first booster dose of any FDA-authorized or FDA-approved COVID-19 vaccine.
Individuals should check with their healthcare provider regarding timing of their booster doses.
To learn about where you can get a booster dose, visit www.vaccines.gov.
Considerations If You Are Immunocompromised
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According to the Emergency Use Authorization Recipients and Caregivers Fact Sheet (12 years of age & older) and Recipients and Caregivers Fact Sheet (5 through 11 years of age), individuals 5 years of age and older with moderately or severely immunocompromising conditions may receive a third primary series dose of vaccine 28 days after their second primary series dose. Immunocompromised persons may have a diminished immune response to the vaccine, and you should continue to maintain physical precautions to help prevent COVID‑19. In addition, your close contacts should be vaccinated as appropriate.
- For individuals 5 years of age and older who have certain kinds of immunocompromise, the vaccine is FDA authorized under Emergency Use Authorization (EUA) as a 3-dose primary series. The first and second dose of the vaccine should be given 3 weeks apart, and the third dose should be given at least 4 weeks (28 days) after the second dose. A booster dose is not FDA authorized for individuals 5 through 11 years of age
For individuals 12 years of age and older who have certain kinds of immunocompromise, the vaccine is FDA authorized under Emergency Use Authorization as a 3-dose primary series. The first and second dose of the vaccine should be given 3 weeks apart, and the third dose should be given at least 4 weeks (28 days) after the second dose. A first booster dose of the vaccine may be administered at least 5 months after completion of a primary vaccination series. A second booster dose of the vaccine may be administered at least 4 months after receipt of a first booster dose of any FDA-authorized or FDA-approved COVID-19 vaccine.
Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine First Booster in Immunocompromised
The CDC has provided guidance that differs from the above FDA-authorized first booster interval for immunocompromised individuals 12 years of age and older. The CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines for healthcare professionals recommends that a booster dose of an mRNA COVID-19 vaccine be given at least 3 months after completion of the third primary series dose for people 12 years of age and older who are moderately or severely immunocompromised.
Your healthcare or vaccination provider will help you decide the timing of your first booster dose that is right for you.
For individuals 12 years of age and older who have certain kinds of immunocompromise, a booster dose of the vaccine is FDA authorized to be given at least 5 months after completion of the 3-dose primary series. A booster dose is not FDA authorized for people 5 through 11 years of age.
Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine First Booster in Immunocompromised
The CDC has provided guidance that differs from the above FDA-authorized first booster interval. The CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines for healthcare professionals recommends that a first booster dose of an mRNA COVID-19 vaccine be given at least 3 months after completion of the third primary series dose for people 12 years of age and older who are moderately or severely immunocompromised.
Your healthcare or vaccination provider will help you decide the timing of your first booster dose that is right for you.
Knowing More About the Vaccine
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When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns.
Individuals 5 through 11 years can only receive the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation identifiable with an orange cap.
There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting the single booster dose. For this reason, your vaccination provider may ask you to stay at the place where you received your booster dose for monitoring after vaccination. Signs of a severe allergic reaction can include:
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Difficulty breathing
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Swelling of your face and throat
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A fast heartbeat
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A bad rash all over your body
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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 vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of 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 vaccine:
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Chest pain
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Shortness of breath
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Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with the vaccine include:
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severe allergic reactions
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non-severe allergic reactions such as rash, itching, hives, or swelling of the face
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myocarditis (inflammation of the heart muscle)
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pericarditis (inflammation of the lining outside the heart)
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injection site pain
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tiredness
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headache
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muscle pain
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chills
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joint pain
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fever
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injection site swelling
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injection site redness
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nausea
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feeling unwell
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swollen lymph nodes (lymphadenopathy)
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decreased appetite
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diarrhea
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vomiting
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arm pain
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fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.
If you experience a severe allergic reaction or other severe symptom, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
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 either “COMIRNATY® (
In addition, you can report side effects to Pfizer Inc. at the contact information provided below.
Website:
www.pfizersafetyreporting.com
Fax
number: 1-866-635-8337
Telephone number: 1-800-438-1985
You should not get the single booster dose if you:
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had a severe allergic reaction after a previous dose of this vaccine
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had a severe allergic reaction to any ingredient of this vaccine
No, the vaccine does not contain preservative.
The vial stoppers are not made with natural rubber latex.
For more information about
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS) and Pfizer Inc.
Updates to non-English Fact Sheets may be delayed.
Español - EUA Fact Sheet for Recipients & Caregivers (12 Years & Up) Español - EUA Fact Sheet for Recipients & Caregivers (5 Through 11 Years of Age)- Patients should always ask their doctors for medical advice about adverse events.
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You are encouraged to report negative side effects of vaccines to the
U.S. Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC). Visit
https://vaers.hhs.gov/reportevent.html
or call
1-800-822-7967 .