Vaccination Is Emergency Use Authorization Parents Be Informed Of Adverse Effects

Updated: Dec 18, 2021

New Label Effective: 10/29/21 The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization from FDA to provide a two-dose primary series to individuals 5 through 11 years of age. This Vaccine Information Fact Sheet (which you can find here) contains information to help you understand the benefits and risks of the vaccine. Talk to your child's vaccination provider if you have questions. The vaccine may not protect everyone. EMERGENCY USE AUTHORIZATION INFORMATION The 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 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.


  • Indication

  • Important Safety Info

  • Report Adverse Event

  • Prescribing Info & Fact Sheets for Vaccination Providers

  • Fact Sheets for Recipients & Caregivers

  • FDA APPROVED 16 Years & Up

  • AUTHORIZED USE 12 Years & Up


​​​​​​​COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA APPROVED for 16 years old & up COMIRNATY® (COVID-19 Vaccine, mRNA) is also known as Pfizer-BioNTech COVID-19 Vaccine* On December 11, 2020, the US Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 of years and older. On August 23, 2021, COMIRNATY® (COVID-19 Vaccine, mRNA)* received FDA approval. ​​​​​​​ The licensed COMIRNATY® vaccine has the same formulation as the authorized vaccine Pfizer-BioNTech COVID-19 Vaccine, and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct, with certain differences that do not impact safety or effectiveness. ​​​​​​​ STAY INFORMEDCDC VACCINE FINDER*SHARE THE NEWS

IMPORTANT SAFETY INFORMATION AND INDICATION & AUTHORIZED USE INDICATION & AUTHORIZED USE HOW IS THE VACCINE GIVEN? The vaccine will be given to you as an injection into the muscle. Primary Series: In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. ​​​​​​​In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise. Booster Dose:

  • A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals:

  • 65 years of age and older

  • 18 through 64 years of age at high risk of severe COVID-19

  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2


  • 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

WHAT IS THE INDICATION AND AUTHORIZED USE? The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

  • a 2-dose primary series to individuals 5 years of age and older

  • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

  • a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:

  • 65 years of age and older

  • 18 through 64 years of age at high risk of severe COVID-19

  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2


  • a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

  • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older

  • It is also authorized under EUA to provide:

  • a 2-dose primary series to individuals 12 through 15 years

  • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

  • a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:

  • 65 years of age and older

  • 18 through 64 years of age at high risk of severe COVID-19

  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2


  • a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series


IMPORTANT SAFETY INFORMATION You should not get the vaccine if you or your child:​​​​​​​

  • had a severe allergic reaction after a previous dose of this vaccine

  • had a severe allergic reaction to any ingredient of this vaccine

Tell the vaccination provider about all medical conditions, including if you or your child:

  • 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

The vaccine may not protect everyone. Side effects reported with the vaccine include:

  • There is a remote chance that the vaccine 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, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination

  • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over your body, dizziness, and weakness

  • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital

  • 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. 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. Individuals should seek medical attention right away if they 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


  • ​​​​​​​Additional side effects that have been reported with the vaccine 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 the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects that do not go away

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.​​​​​​​ ​​​​​​​​​​​Click for Fact Sheets and Prescribing Information for individuals 12 years of age and older Full Prescribing Information (16 years of age and older) 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)​​​​​​​


Health care


Label Update: Effective 10/29/21 THREE VACCINE PRESENTATIONS ARE NOW AVAILABLE Three vaccine presentations are now available with different preparation and storage guidelines. 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. DescriptionDilute Before UseDo Not DiluteDilute Before UseAge Group12 years and older12 years and older 5 through 11 years ("Age 5y to <12y" on vial label)Vial Cap ColorPURPLE GRAY ORANGE Dose30 mcg30 mcg10 mcgDose Volume0.3 mL0.3 mL0.2 mLAmount of Diluent Needed per Vial*1.8 mLNO DILUTION1.3 mLDoses per Vial6 doses per vial (after dilution)6 doses per vial10 doses per vial (after dilution)Emergency Use Authorization (EUA) Fact Sheet Click hereClick hereClick hereStorage ConditionsUltra-Low-Temperature (ULT) Freezer [-90°C to -60°C (-130°F to -76°F)]9 months†6 months‡6 months‡Freezer [-25°C to -15°C (-13°F to 5°F)]2 weeksDO NOT STOREDO NOT STORERefrigerator [2°C to 8°C (35°F to 46°F)]1 month10 weeks10 weeksRoom Temperature [8°C to 25°C (46°F to 77°F)]2 hours prior to dilution (including any thaw time)12 hours prior to first puncture12 hours prior to dilutionAfter First Puncture [2°C to 25°C (35°F to 77°F)] Discard after 6 hoursDiscard after 12 hoursDiscard after 12 hours*Diluent: sterile 0.9% Sodium Chloride Injection, USP. Bacterostatic saline or other diluents must NOT be used. †Regardless of storage condition, vaccine should not be used past the 9 month expiry (6 months printed on the vial plus additional 3 months). ‡Regardless of storage condition, vaccines should not be used after 6 months from the date of manufacture printed on the vial and cartons. I acknowledge that this website is being updated on an ongoing basis. Unless otherwise specified, the remainder of the website applies only to the Ages 12 & Up DILUTE BEFORE USE Purple Cap Presentation. I have read the Important Safety Information below. I will check back for further updates. Continue 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/covid-19/clinical-considerations/managing-anaphylaxis.html). Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. 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 Fact Sheets and Prescribing Information for individuals 12 years of age and older Full Prescribing Information (16 years of age and older) 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 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), DILUTE BEFORE USE, Orange Cap Recipients and Caregivers Fact Sheet (5 through 11 years of age)

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