Booster Doses of the Vaccine Are Authorized for Persons Who Meet the Guidelines Below
Single Booster Dose Available:
-
To individuals 5 through 11 years of age who have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine.
First Booster Dose Available:
-
To individuals 12 years of age and older who have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine orCOMIRNATY® (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:
-
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) for use in individuals 6 months of age and older. 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 Booster Doses
Open all
Close all
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 or plan to become pregnant
-
are breastfeeding
-
have received another
COVID-19 vaccine -
have ever fainted in association with an injection
FDA-Approved or FDA-Authorized Vaccination Schedule
A single booster dose may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.
A single booster dose may be administered at least 5 months after completion of a primary series of the
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. The booster schedule is based on the labeling information of the vaccine used for primary series.
A second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine.
A second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.
Individuals should check with their healthcare provider regarding timing of their booster dose.
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. The booster schedule is based on the labeling information of the vaccine used for the primary series.
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
Open all
Close all
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.
FDA-Approved or FDA-Authorized Vaccination Schedule
For individuals 5 through 11 years of age who have certain kinds of immunocompromise,
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 with
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.
FDA-Approved or FDA-Authorized Vaccination Schedule
For individuals 5 through 11 years of age, a single booster dose of the vaccine is FDA authorized to be given at least 5 months after completion of the primary series with
For individuals 12 years of age and older, a first booster dose of the vaccine is FDA authorized to be given at least 5 months after completion of the primary series with
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.
You should not get the single booster dose 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
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.
-
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 .