An Additional Dose of the Vaccine Is Authorized for Persons Who Meet the Guidelines Below
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.”
A third dose is administered to individuals who have been determined to have certain kinds of immunocompromise. CDC recommends that people with moderately to severely compromised immune systems receive an additional dose of the vaccine.
According to the CDC, a booster shot is administered when a person has completed their vaccine series and protection against the virus has decreased over time.
What should I mention to my vaccination provider before I get the booster dose?
How do I know if I qualify for a booster dose?
Can I get the Pfizer-BioNTech COVID-19 Vaccine booster dose if the original vaccine I received was not the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)?
A single booster dose of the vaccine may be administered to certain individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Please check with your healthcare provider regarding eligibility for, and timing of, the booster dose.
Where can I get a booster dose?
To learn about where you can get a booster dose, visit www.vaccines.gov.
What if I am immunocompromised?
When do I receive my third dose of the vaccine?
Is the Pfizer-BioNTech COVID-19 Vaccine the same as COMIRNATY® (COVID-19 Vaccine, mRNA)?
What are the risks of the vaccine?
What should I do about side effects?
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® (COVID-19 Vaccine, mRNA)” or “Pfizer-BioNTech COVID-19 Vaccine EUA”, as appropriate, in the first line of box #18 of the report form.
In addition, you can report side effects to Pfizer Inc. at the contact information provided below.
Fax number: 1-866-635-8337
Telephone number: 1-800-438-1985
Who should not get the booster dose?
Is there preservative in the vaccine?
No, the vaccine does not contain preservative.
Are the components of the vaccine vial made with latex?
The vial stoppers are not made with natural rubber latex.
Where can I learn more?
For more information about COVID-19 vaccination, please visit the CDC website.
Patients should always ask their healthcare providers for medical advice about adverse events. Report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1‐800‐822‐7967. In addition, you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Indication & Authorized Use
You should not get the vaccine if you or your child:
Tell the vaccination provider about all medical conditions, including if you or your child:
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for medical advice about adverse events. Report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1-800-822-7967. In addition, you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, Purple Cap
Full Prescribing Information (16 years of age and older) DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
Indication & Authorized Use