Authorized Use: Booster Info

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Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is available for ages 5 years & up, currently at no cost to you.

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Bivalent booster for people
5 years of age and older Pfizer-BioNTech
COVID-19 Vaccine,
Bivalent

Updated to help protect
against COVID-19
Omicron variant BA.4/BA.5

The vaccine may not protect everyone.

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Bivalent booster for people
5 years of age and older

PFIZER-BIONTECH
COVID-19
VACCINE,
BIVALENT

Updated to help protect against COVID-19
Omicron variant BA.4/BA.5

The vaccine may not protect everyone.

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 individuals aged 5 years 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.

Emergency uses of the vaccines 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 individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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.

Emergency uses of the vaccines 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 individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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.

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WHAT IS THE BIVALENT BOOSTER?

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)* was designed as a response to increasing rates of infection caused by certain COVID-19 variants—in particular the Omicron variant BA.4/BA.5.

*Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

The bivalent booster is available as:

A single booster dose for people 5 years of age and older administered at least 2 months after:

  • Completion of primary vaccination with any authorized or approved monovalent† COVID-19 vaccine; or
  • Receipt of the most recent booster dose with any authorized or approved monovalent† COVID-19 vaccine

†Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the original SARS-CoV-2.

For ages 5 through 11 years, the bivalent booster comes in a vial with an orange cap

For ages 12 years and older, the bivalent booster comes in a vial with a gray cap

Please check back for more information and further updates about Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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YOUR QUESTIONS ABOUT THE
BIVALENT BOOSTER —- ANSWERED

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If you’re considering the bivalent booster for yourself or your child aged 5 years and older, the information below can help you get started.

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What’s the difference between the original monovalent booster formulation called Pfizer-BioNTech COVID-19 Vaccine and the updated bivalent booster formulation called Pfizer-BioNTech COVID-19 Vaccine, Bivalent?
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Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) was designed as a response to increasing rates of infection caused by certain COVID-19 variants—in particular Omicron variant BA.4/BA.5. It is made in the same way as Pfizer-BioNTech COVID-19 Vaccine. However, it contains two components—one component for the original strain of SARS-CoV-2 and the other for the Omicron variant BA.4/BA.5.

Authorization of the updated booster (called Pfizer-BioNTech COVID-19 Vaccine, Bivalent) means that the original booster (called Pfizer-BioNTech COVID-19 Vaccine) is no longer authorized and should not be used for individuals 5 years of age and older as a booster.

Is the bivalent vaccine booster designed to help protect against the Omicron variant?
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Pfizer-BioNTech COVID-19 Vaccine, Bivalent contains two components: one component of the original strain of SARS-CoV-2 and the other for the Omicron variant BA.4/BA.5. The Omicron variant BA.4/BA.5 is currently causing many cases of COVID-19 in the US and is predicted to circulate this fall and winter.

I’ve already had COVID-19. Should I still get a booster dose?
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Even if you’ve already had COVID-19, a booster dose can help provide added protection against COVID-19. Talk to your healthcare provider to see when a booster dose is right for you.

How soon after my last booster dose can the updated booster—called Pfizer-BioNTech COVID-19 Vaccine, Bivalent—be given?
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For individuals 5 years of age and older, the dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent can be administered as a single booster at least 2 months after your most recent booster dose of any authorized or approved monovalent COVID-19 vaccine.

I’ve never been vaccinated for COVID-19. Can I get Pfizer-BioNTech COVID-19 Vaccine, Bivalent for my primary series?
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No, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not authorized to be given as a primary series vaccination. It is authorized as a single booster dose to individuals 5 years of age and older at least 2 months after completion of a primary vaccine series with any authorized or approved monovalent COVID-19 vaccine or as a single booster dose at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Is the bivalent booster available in my area?
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Pfizer-BioNTech COVID-19 Vaccine, Bivalent is available wherever any previously authorized or approved original monovalent Pfizer-BioNTech COVID-19 Vaccine is available.

You can quickly see if Pfizer-BioNTech COVID-19 Vaccine, Bivalent is available in your area by using the CDC Vaccine Finder here.

What should I mention to my vaccination provider before I get the vaccine?
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Tell your 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 the 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
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Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
Authorized Uses, and
Important Safety Information

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
Authorized Uses, and
Important Safety Information

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AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either:

  • completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or
  • receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine

*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus.


EMERGENCY USE AUTHORIZATION

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 individuals aged 5 years 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.

IMPORTANT SAFETY INFORMATION

Tell your 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 the 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
  • Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) may not protect all vaccine recipients
  • You should not receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) if you have had a severe allergic reaction after a previous dose of COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine or had a severe allergic reaction to any ingredient in these vaccines
  • There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms:

  • difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the 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 COMIRNATY® (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. 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:
  • chest pain
  • shortness of breath
  • feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported with these vaccines 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)
  • Decreased appetite
  • Diarrhea
  • Vomiting
  • Arm pain
  • Fainting in association with injection of the vaccine

These may not be all the possible side effects of these vaccines. Serious and unexpected side effects may occur. The possible side effects of these vaccines are still being studied.

Some people with weakened immune systems may have reduced immune responses to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).

  • Individuals should always ask their healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov/reportevent.html. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Fact Sheets for individuals 5 years of age and older:

EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)

EUA Fact Sheet for Vaccination Providers (12 years of age and older), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age) BIVALENT (Original and Omicron BA.4/BA.5), DILUTE BEFORE USE, Orange Cap

AUTHORIZED USES

IMPORTANT SAFETY INFORMATION

Vector

IMPORTANT SAFETY INFORMATION

Vector

Tell your vaccination provider about all of your medical conditions, including if you:

  • have any allergies
  • have had myocarditis (inflammation

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either:

  • completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or
  • receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine

*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus.


EMERGENCY USE AUTHORIZATION

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 individuals aged 12 years 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.

Booster Series

  • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine
  • a first booster dose 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)
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or 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 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

COMIRNATY® INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.


HOW IS COMIRNATY® GIVEN?

COMIRNATY® is administered as an injection into the muscle as a 2-dose primary series, 3 weeks apart.


COMIRNATY® AUTHORIZED USES

COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:


Primary Series

  • a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise

Booster Dose

  • a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or 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 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

EMERGENCY USE AUTHORIZATION

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.


INTERCHANGEABILITY

FDA approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.


The formulations of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, 5 through 11 years of age, and 12 years of age and older are different and should therefore not be used interchangeably.


Read Full Indication and Authorized UseArrow

IMPORTANT SAFETY INFORMATION

Tell your 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 the 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
  • Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) may not protect all vaccine recipients
  • You should not receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) if you have had a severe allergic reaction after a previous dose of COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine or had a severe allergic reaction to any ingredient in these vaccines
  • There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) could cause a severe allergic reaction A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
  • Seek medical attention right away if the vaccine recipient has any of the following symptoms:difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the 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 vaccine, more commonly in adolescent males and adult 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 the vaccine. The chance of having this occur is very low

Seek medical attention right away if the vaccine recipient has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a vaccine dose:

  • Chest pain
  • Shortness of breath or difficulty breathing
  • Feelings of having a fast-beating, fluttering, or pounding heart
  • Fainting
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin

  • Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine
  • Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • Additional side effects include rash, itching, hives, swelling of the face, injection site pain, tiredness, feeling weak or lack of energy, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, arm pain, fainting in association with injection of the vaccine, and irritability

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

  • You should always ask your healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov/reportevent.html. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Fact Sheets and Prescribing Information for individuals 6 months of age and older:

Recipients and Caregivers Fact Sheet (6 months through 4 years of age)
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
Recipients and Caregivers Fact Sheet (12 years of age and older)
COMIRNATY® Full Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap
COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
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Read Full Indication and Authorized UseArrow
Read Full Important Safety InformationArrow

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REPORT VACCINE SIDE EFFECTS

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Report an adverse event to the FDA/CDC Vaccine Adverse
Event Reporting System (VAERS).

Report to VAERS
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Report an adverse event to
Pfizer Inc.

Report to Pfizer

Report an adverse event to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

Report to VAERS

Report an adverse event to
Pfizer Inc.

Report to Pfizer
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VACCINE AUTHENTICITY:

WHAT YOU NEED TO KNOW

WHAT YOU NEED
TO KNOW

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Around the world, Pfizer and BioNTech are working in partnership with government agencies to safely and efficiently distribute the vaccine. There are currently no legitimate COVID-19 vaccines produced by any manufacturer that are available for purchase by individuals.


We urge everyone to be wary of any offers for COVID-19 vaccinations that do not come from an authorized source—meaning, from anyone other than a healthcare provider or local government health agency.

The vaccine:

  • Is NOT sold online. Any sales of COVID-19 vaccines over the Internet, including from online pharmacies, are not legitimate
  • Cannot be purchased in individual doses
  • Is not taken by mouth and is not available in a capsule or tablet form
  • Can only be administered by licensed healthcare professionals at government-authorized vaccination centers—such as doctors’ offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals
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FOR MORE INFORMATION

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Call your healthcare provider with any additional questions.

General Product Inquiries:

General Product Inquiries:
Call 1-877-829-2619

Call 1-877-829-2619

Medical Information:

Visit PfizerMedicalInformation.com or call 1-800-438-1985

Medical Information: Visit
PfizerMedicalInformation.com or call 1-800-438-1985