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Primary Series

12 years of age and older

COMIRNATY® (COVID-19 Vaccine, mRNA): FDA APPROVED FOR INDIVIDUALS 12 YEARS OF AGE AND OLDER AS A TWO-DOSE PRIMARY SERIES1,2

In individuals 12 years of age and older, COMIRNATY® (COVID-19 Vaccine, mRNA) has been approved as a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2.


FDA AUTHORIZED FOR EMERGENCY USE3-7

Emergency uses of Pfizer-BioNTech COVID-19 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 individuals aged 6 months 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 (Primary Series for Individuals 12 Years of Age and Older)
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Because of the potential for vaccine administration errors, including dosing errors, vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

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The vaccine is available in four presentations with different dosing, preparation, and storage guidelines.1-4 There are two presentations (Purple Cap or Gray Cap) for individuals 12 years of age and older, outlined below.

Learn more about the vaccine presentations.

12 YEARS OF AGE AND OLDER,
DO NOT DILUTE
(GRAY CAP)
12 YEARS OF AGE AND OLDER,
DILUTE BEFORE USE
(PURPLE CAP)

Learn about the clinical trial experience and results for the Pfizer-BioNTech COVID-19 Vaccine

When prepared according to their respective
instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Because of the potential for vaccine administration errors, including dosing errors, COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

For vaccination of individuals advancing into the next age group (4 years of age turning 5 years of age or 11 years of age turning 12 years of age) between any primary series dose, refer to the respective age-based Fact Sheet for Healthcare Providers for instructions for administration.

References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; July 8, 2022.
  2. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; July 8, 2022.
  3. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; August 31, 2022.
  4. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose for 12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; August 31, 2022.
  5. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; August 31, 2022.
  6. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; August 31, 2022.
  7. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap. Pfizer and BioNTech; August 31, 2022.

Indication & Authorized Use

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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Indication & Authorized Use


COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated 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. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

Pfizer-BioNTech COVID-19 Vaccine

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Because of the potential for vaccine administration errors, including dosing errors, vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use under an Emergency Use Authorization (EUA) 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.



Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of these vaccines.

Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the 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. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Limitation of Effectiveness

Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.

Adverse Reactions

Primary Series Adverse Events:

Pfizer-BioNTech COVID-19 Vaccine

In a clinical study (3 mcg modRNA) in participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (3 mcg modRNA) in participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY

In clinical studies (30 mcg modRNA) of adolescents 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) were pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), and injection site redness (8.6%).

In clinical studies (30 mcg modRNA) of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).

In clinical studies (30 mcg modRNA) of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).

Booster Dose Adverse Events:

Pfizer-BioNTech COVID-19 Vaccine

In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).

Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY

In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent is based on:

  • safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1),
  • safety data from clinical trials which evaluated primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, and
  • post marketing safety data with Pfizer-BioNTech COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants 55 years of age and older. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).

In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Pfizer-BioNTech COVID-19 Vaccine and post authorization use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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