Important Safety Information
Do not administer Pfizer-BioNTech
COVID-19 Vaccine, Bivalent to individuals with a known
history of a severe allergic reaction (e.g., anaphylaxis) to any
component of Pfizer-BioNTech
COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY® (COVID-19 Vaccine, mRNA).
Management of Acute Allergic Reactions
Appropriate medical treatment 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,
Bivalent.
Monitor Pfizer-BioNTech COVID-19 Vaccine,
Bivalent recipients for the occurrence of immediate adverse
reactions according to the Centers for Disease Control and
Prevention (CDC) guidelines ().
Myocarditis and Pericarditis
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 vaccination. For the Pfizer-BioNTech
COVID-19 Vaccine, 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. Procedures should be in place to avoid injury
from fainting.
Altered Immunocompetence
Immunocompromised persons, including individuals receiving
immunosuppressive therapy, may have a diminished response to
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent.
Limitation of Vaccine Effectiveness
Pfizer-BioNTech COVID-19 Vaccine, Bivalent
may not protect all vaccine recipients.
Adverse Reactions
The safety of Pfizer-BioNTech
COVID-19 Vaccine, Bivalent in individuals 6 months of
age and older is based on the safety data accrued from the
formulations described below because these vaccines are manufactured
using the same process:
-
safety data from clinical trials which evaluated primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine (monovalent formulation is no longer authorized for use in the United States),
-
safety data from clinical trials which evaluated booster
vaccination with Pfizer-BioNTech COVID-19 Vaccine, Bivalent,
-
safety data from a clinical study which evaluated a booster dose
of bivalent vaccine (Original and Omicron BA.1), [not authorized
or approved in the U.S., hereafter referred to as bivalent vaccine
(Original and Omicron BA.1)] and
-
postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine (monovalent formulation is no longer authorized for use in the United States) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Solicited adverse reactions include:
-
6 months through 23 months of age:
Injection site redness, swelling, and tenderness; decreased appetite, drowsiness, fever, irritability.
-
2 years of age and older:
Injection site pain, redness, and swelling; chills, diarrhea, fatigue, fever, headache, new or worsened joint pain, new or worsened muscle pain, vomiting.
Additional adverse reactions, some of which may be serious, may
become apparent with more widespread use of Pfizer-BioNTech COVID-19
Vaccine, Bivalent.
Vaccination providers enrolled in the federal COVID-19 Vaccination
Program must report all vaccine administration errors and all
serious adverse events to the Vaccine Adverse Event Reporting System
(VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer‑BioNTech COVID‑19 Vaccine, Bivalent EUA” in the description section of the report. To the extent feasible, report adverse events to Pfizer 1-800-438-1985 or provide a copy of the VAERS form to Pfizer www.pfizersafetyreporting.com
Please click for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider and Recipient and Caregiver EUA Fact Sheets