Important Safety Information
Do not administer Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY (COVID-19 Vaccine, mRNA), or Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the 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 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 ().
Myocarditis and Pericarditis
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
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 ().
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 Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Limitation of Effectiveness
Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.
Adverse Reactions
The safety of a booster dose of Pfizer-BioNTech
COVID-19 Vaccine, Bivalent (individuals 5 years of age and older) and the safety of Pfizer-BioNTech COVID-19 Vaccine for the third dose of the primary series or booster dose in individuals 6 months through 4 years of age is based on:
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safety data from clinical studies which evaluated a booster dose of Pfizer-BioNTech, Bivalent (Original and Omicron BA.4/BA.5) in individuals 6 months of age and older,
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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) in individuals greater than 55 years of age,
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The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID‑19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
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safety data from clinical studies which evaluated primary vaccination with Pfizer-BioNTech
COVID-19 Vaccine in individuals 6 months of age and older and
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safety data from clinical studies which evaluated booster vaccination with Pfizer-BioNTech
COVID-19 Vaccine (previously, but no longer, authorized) in individuals 5 years of age and older, and
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postmarketing safety data with Pfizer-BioNTech
COVID-19 Vaccine and Pfizer-BioNTech
COVID-19 Vaccine, Bivalent
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 of
Pfizer-BioNTech COVID-19 Vaccine 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 of
Pfizer-BioNTech COVID-19 Vaccine 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 participants
5 through 11 years of age, adverse reactions
following administration of any primary series dose of
Pfizer-BioNTech COVID-19 Vaccine 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%).
In a clinical study (10 mcg modRNA) in participants 5 through 11 years of age, adverse reactions following administration of a single booster dose of Pfizer-BioNTech COVID-19 Vaccine 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%).
In clinical studies (30 mcg modRNA) in participants 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) following any dose of Pfizer-BioNTech COVID-19 Vaccine 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) in participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) following any dose of Pfizer-BioNTech COVID-19 Vaccine 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 a clinical study (30 mcg modRNA) in 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%). Severe allergic reactions (including anaphylaxis), myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine.
In clinical studies (30 mcg modRNA) in participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) following any dose of Pfizer-BioNTech COVID-19 Vaccine 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%).
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
In a clinical study (3 mcg modRNA) in participants 6 through 23 months of age who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, adverse reactions following administration of the vaccine included irritability (18.2%), drowsiness (9.1%), injection site redness (8.3%), decreased appetite (4.5%), fatigue (4.2%), fever (4.2%), pain at the injection site (4.2%), and injection site swelling (4.2%).
In a clinical study (3 mcg modRNA) in participants 2 through 4 years of age who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, adverse reactions following administration of the vaccine included fatigue (30.6%), pain at the injection site (27.8%), injection site redness (8.3%), diarrhea (5.6%), injection site swelling (2.8%), vomiting (2.8%), headache (2.8%), joint pain (2.8%), and chills (2.8%).
In a clinical study (10 mcg modRNA) in participants 5 through 11 years of age who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, adverse reactions following administration of the vaccine included pain at the injection site (64.0%), fatigue (40.5%), headache (25.2%), muscle pain (13.5%), joint pain (9.0%), chills (9.0%), injection site redness (7.2%), fever (4.5%), injection site swelling (4.5%), vomiting (3.6%), diarrhea (3.6%), and lymphadenopathy (0.9%).
In a clinical study (30 mcg modRNA) in participants 12 years of age and older who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, adverse reactions following administration of the vaccine included pain at the injection site (68.5%), fatigue (56.4%), headache (41.4%), muscle pain (25.8%), chills (16.9%), joint pain (13.4%), diarrhea (9.6%), fever (7.3%), injection site swelling (5.4%), injection site redness (4.5%), vomiting (1.9%), and lymphadenopathy (0.3%).
Bivalent Vaccine (Original and Omicron BA.1)
The clinical study (30 mcg modRNA) that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. 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%).
Post Authorization Experience
Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), syncope, and dizziness have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
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 Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Before administration, please click to see:
EUA Fact Sheet for Vaccination Providers
Full Prescribing Information
EUA Fact Sheet for Recipients and Caregivers
