Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve.
Click here to learn how we are responding.
Indication & Authorized Use
Authorized Use & Indication
Important Safety Information
Indication & Authorized Use
COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus disease 2019
The FDA-approved COMIRNATY®
COMIRNATY®
The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older to provide:
Important Safety Information
Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
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/
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. 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 (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
The vaccine may not protect all vaccine recipients.
Primary Series Adverse Events:
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%).
In a clinical study (30 mcg modRNA) of adolescents 12 through 15 years of age, adverse reactions following the administration of the primary series included 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%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).
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%).
Booster Dose Adverse Events:
In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a 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%).
Before administration of the vaccine, please click to see
Labeling Update: Effective 04/26/22
The Emergency Use Authorization (EUA) Fact Sheets for Vaccination
Providers for individuals 12 years of age and older have been updated. Changes include (but are not limited to) the following sections:
New Information in Teal
2.3 Vaccination Schedule
Booster Doses
Second Booster Dose
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) may be administered at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine to individuals 12 years of age and older with certain kinds of immunocompromise.
Click below to view:
Three vaccine presentations are available with different preparation and storage guidelines.
As of 04/13/22,
Ages 12 years and older, DO NOT DILUTE (Gray Cap)
and
5 through 11 years, DILUTE BEFORE USE (Orange Cap)
have extended expiry from 9 months to 12 months from the date of
manufacture printed on the vial and cartons
in an Ultra-Low-Temperature (ULT) Freezer -90°C to -60°C (-130°F to
-76°F).
As of 04/26/22, Ages 12 years and older, DILUTE BEFORE USE (Purple Cap), has extended the expiry date from 9 months to 12 months from the printed expiry date on the vial and cartons in a ULT Freezer -90°C to -60°C (-130°F to -76°F).
Children ages 5 through 11 years old should only be vaccinated with the Ages 5 through 11 years (“Age 5y to <12y” on vial label) DILUTE BEFORE USE ORANGE CAP presentation. No other vaccine presentation should be used for children 5 through 11 years old because of the potential for vaccine administration errors, including dosing errors. For children who will turn 12 between their first and second dose, consult the EUA Fact Sheets for Vaccination Providers.
For questions, contact US Medical Information at 1-800-438-1985 or visit PfizerMedicalInformation.com.
| Description | Dilute Before Use | Do Not Dilute | Dilute Before Use |
|---|---|---|---|
| Age Group | 12 years and older | 12 years and older |
5 through 11 years ("Age 5y to <12y" on vial label) |
| Vial Cap Color |
PURPLE
|
GRAY
|
ORANGE
|
| Dose | 30 mcg | 30 mcg | 10 mcg |
| Dose Volume | 0.3 mL | 0.3 mL | 0.2 mL |
| Amount of Diluent Needed per Vial* | 1.8 mL | NO DILUTION | 1.3 mL |
| Doses per Vial | 6 doses per vial (after dilution) |
6 doses per vial | 10 doses per vial (after dilution) |
| Emergency Use Authorization (EUA) Fact Sheet | Click here | Click here | Click here |
| Storage Conditions | |||
|
Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C |
12 months† | 12 months‡ | 12 months‡ |
|
Freezer [-25°C to -15°C |
2 weeks | DO NOT STORE | DO NOT STORE |
|
Refrigerator [2°C to 8°C |
1 month | 10 weeks | 10 weeks |
|
Room Temperature [8°C to 25°C |
2 hours prior to dilution (including any thaw time) |
12 hours prior to first puncture (including any thaw time) |
12 hours prior to dilution (including any thaw time) |
|
After First Puncture [2°C to 25°C |
Discard after 6 hours | Discard after 12 hours | Discard after 12 hours |
| Description | Dilute Before Use | ||
|---|---|---|---|
| Age Group | 12 years and older | ||
| Vial Cap Color |
PURPLE
|
||
| Dose | 30 mcg | ||
| Dose Volume | 0.3 mL | ||
| Amount of Diluent Needed per Vial* | 1.8 mL | ||
| Doses per Vial | 6 doses per vial (after dilution) |
||
| Emergency Use Authorization (EUA) Fact Sheet | Click here | ||
| Storage Conditions | |||
|
Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C |
12 months† | ||
|
Freezer [-25°C to -15°C |
2 weeks | ||
|
Refrigerator [2°C to 8°C |
1 month | ||
|
Room Temperature [8°C to 25°C |
2 hours prior to dilution (including any thaw time) |
||
|
After First Puncture [2°C to 25°C |
Discard after 6 hours | ||
| Description | Do Not Dilute | ||
|---|---|---|---|
| Age Group | 12 years and older | ||
| Vial Cap Color |
GRAY
|
||
| Dose | 30 mcg | ||
| Dose Volume | 0.3 mL | ||
| Amount of Diluent Needed per Vial* | NO DILUTION | ||
| Doses per Vial | 6 doses per vial | ||
| Emergency Use Authorization (EUA) Fact Sheet | Click here | ||
| Storage Conditions | |||
|
Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C |
12 months‡ | ||
|
Freezer [-25°C to -15°C |
DO NOT STORE | ||
|
Refrigerator [2°C to 8 °C |
10 weeks | ||
|
Room Temperature [8°C to 25°C |
12 hours prior to first puncture (including any thaw time) |
||
|
After First Puncture [2°C to 25°C |
Discard after 12 hours | ||
| Description | Dilute Before Use | ||
|---|---|---|---|
| Age Group |
5 through 11 years ("Age 5y to <12y" on vial label) |
||
| Vial Cap Color |
ORANGE
|
||
| Dose | 10 mcg | ||
| Dose Volume | 0.2 mL | ||
| Amount of Diluent Needed per Vial* | 1.3 mL | ||
| Doses per Vial | 10 doses per vial (after dilution) |
||
| Emergency Use Authorization (EUA) Fact Sheet | Click here | ||
| Storage Conditions | |||
|
Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C |
12 months‡ | ||
|
Freezer [-25°C to -15°C |
DO NOT STORE | ||
|
Refrigerator [2°C to 8°C |
10 weeks | ||
|
Room Temperature [8°C to 25°C |
12 hours prior to dilution (including any thaw time) |
||
|
After First Puncture [2°C to 25°C |
Discard after 12 hours | ||
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) in individuals 5 years 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.
I acknowledge that this website is being updated on an ongoing basis. I will check back for further updates.
