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Authorized Use EUA Fact Sheets EUA Le�ers Report Adverse Event Tools
COVID-19
Emergency uses of the vaccine have not been approved or licensed by the FDA, but
have been authorized by the FDA, under an Emergency Use Authorization (EUA) to
prevent Coronavirus Disease 2019 (COVID-19). The Moderna COVID-19 Vaccine is
authorized in individuals 6 months of age and older as a primary series. The Moderna
COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals 6 months
through 5 years of age at least 2 months a�er the Moderna COVID-19 Vaccine primary
series and is authorized in individuals 6 years of age and older at least 2 months a�er
any authorized or approved vaccine.
The EUA for these products is in e�ect for the duration of the COVID-19 EUA declaration
justifying emergency use of the product, unless the declaration is terminated or the
authorization is revoked sooner.
For more information on the EUA authorized uses of the vaccine, refer to the Vaccine
Fact Sheets for Recipients and Caregivers.
What should you mention to the vaccination provider before you or your child gets
these vaccines?
Tell your vaccination provider about all medical conditions, including if you or your child:
are immunocompromised or are on a medicine that a�ects your or your child’s immune
With the Moderna COVID-19 Vaccine, Bivalent, you and your child's doctor have another
system
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Moderna COVID-19 Vaccines | Info for Teens https://eua.modernatx.com/recipients/teens
tool to
help
protect
your child
from
COVID-19.
Minimize -
AUTHORIZED USE
Eligibility and dosing for teens
Emergency uses of the vaccine have not been approved or licensed by the FDA, but
Moderna COVID-19
have been Vaccine,
authorized by Bivalent
the FDA,should
under be
an given at least
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Use a�er people
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(EUA) to
through 17 years
prevent of age have
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Disease 2019 (COVID-19). The Moderna COVID-19 Vaccine is
authorized in individuals 6 months of age and older as a primary series. The Moderna
A booster Vaccine,
COVID-19 dose of the original
Bivalent Moderna COVID-19
is authorized Vaccine
as a booster doseorinanother authorized
individuals 6 months
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series and(original)
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The EUA for these products is in e�ect for the duration of the COVID-19 EUA declaration
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revoked sooner.
For more information on the EUA authorized uses of the vaccine, refer to the Vaccine
The vaccine is administered as a 2-dose primary series, 1 month apart
Fact Sheets for Recipients and Caregivers.
A third primary series dose may be administered at least 1 month a�er the second dose
to should
What people you
withmention
certain kinds ofvaccination
to the immunocompromise
provider before you or your child gets
these vaccines?
Tell your vaccination provider about all medical conditions, including if you or your child:
have a fever
Primary series
have a bleeding vaccine:
disorder or are onHelps protect against COVID-19
a blood thinner
are immunocompromised or are on a medicine that a�ects your or your child’s immune
A U.S. clinical study conducted by Moderna, known as the TeenCOVE trial, measured the
system
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safety and e�cacy of the Moderna COVID-19 Vaccine in healthy adolescents 12 through 17
years of age.
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Emergency
Based onuses of the vaccine
the Centers have Control
for Disease not been approved
and or licensed
Prevention by the
(CDC) case FDA, but
definition*
have been authorized by the FDA, under an Emergency Use Authorization (EUA) to
prevent Coronavirus Disease 2019 (COVID-19). The Moderna COVID-19 Vaccine is
authorized in individuals 6 months of age and older as a primary series. The Moderna
COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals 6 months
through 5 years of age at least 2 months a�er the Moderna COVID-19 Vaccine primary
series and is authorized in individuals 6 years of age and older at least 2 months a�er
any authorized or approved vaccine.
The EUA for these products is in e�ect for the duration of the COVID-19 EUA declaration
justifying emergency use of the100% e�ective
product, unlessagainst
the declaration is terminated or the
authorization is revoked sooner. COVID-19 infection
What should you mention to the vaccination provider before you or your child gets
* these
CDC case vaccines?
definition: 1 systemic symptom and a positive reverse transcription polymerase chain reaction (RT-PCR).
†
Tell your vaccination provider about all medical conditions, including if you or your child:
COVE case definition: 2 systemic or 1 respiratory symptom and a positive RT-PCR.
have a fever
are immunocompromised or are on a medicine that a�ects your or your child’s immune
system
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have a feveruses of the vaccine have not been approved or licensed by the FDA, but
Emergency
have a been authorized
bleeding by the
disorder FDA,
or are on under anthinner
a blood Emergency Use Authorization (EUA) to
prevent Coronavirus Disease 2019 (COVID-19). The Moderna COVID-19 Vaccine is
are immunocompromised or are on a medicine that a�ects your immune system
authorized in individuals 6 months of age and older as a primary series. The Moderna
are pregnant
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is authorized
through
are 5 years of age at least 2 months a�er the Moderna COVID-19 Vaccine primary
breastfeeding
series and is authorized in individuals 6 years of age and older at least 2 months a�er
have received another COVID-19 vaccine
any authorized or approved vaccine.
have ever fainted in association with an injection
The EUA for these products is in e�ect for the duration of the COVID-19 EUA declaration
justifying emergency use of the product, unless the declaration is terminated or the
authorization
Download What tois revoked sooner.
Expect Guide
For more information on the EUA authorized uses of the vaccine, refer to the Vaccine
Fact Sheets for Recipients and Caregivers.
What should you mention to the vaccination provider before you or your child gets
these vaccines?
Tell your vaccination provider about all medical conditions, including if you or your child:
have a bleeding
Severe disorder or are on a blood thinner
allergic reactions
are immunocompromised or are on a medicine that a�ects your or your child’s immune
Urticaria
system
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If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
For individuals 6 years of age and older, general side e�ects can include: Minimize -
Fatigue
IMPORTANT SAFETY INFORMATION Close
Headache
AUTHORIZED USE
Muscle pain
Joint pain uses of the vaccine have not been approved or licensed by the FDA, but
Emergency
Chillsbeen authorized by the FDA, under an Emergency Use Authorization (EUA) to
have
prevent
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and vomitingDisease 2019 (COVID-19). The Moderna COVID-19 Vaccine is
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through 5 years of age at least 2 months a�er the Moderna COVID-19 Vaccine primary
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The EUA for these products e�ect for the duration the declaration
justifying emergency use of the product, unless the declaration is terminated or the
See Safety Info
authorization is revoked sooner.
For more information on the EUA authorized uses of the vaccine, refer to the Vaccine
Fact Sheets for Recipients and Caregivers.
What should you mention to the vaccination provider before you or your child gets
these vaccines?
Tell your vaccination provider about all medical conditions, including if you or your child:
Frequently Asked
have had myocarditis Questions
(inflammation of the heart muscle) or pericarditis (inflammation of
the lining outside the heart)
We have answers in the FAQ section.
have a fever
are immunocompromised or are on a medicine that a�ects your or your child’s immune
system
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AUTHORIZED USE
Phone
What Number
should you mention to the vaccination provider before you or your child gets
these vaccines?
Tell your vaccination provider about all medical conditions, including if you or your child:
haveI'dany
likeallergies
to receive Moderna communications via email. I understand that I can opt out
haveathad
anymyocarditis
time (inflammation of the heart muscle) or pericarditis (inflammation of
the lining outside the heart)
By submi�ing your information, you agree to Moderna’s Terms and Conditions. You also
have a fever
acknowledge that your information will be processed in accordance with Moderna’s Privacy
have a bleeding disorder or are on a blood thinner
Policy.
are immunocompromised or are on a medicine that a�ects your or your child’s immune
system
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This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Services
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Subscribe
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About Moderna
IMPORTANT SAFETY INFORMATION Close
ModernaTX.com
AUTHORIZED USE
1-866-MODERNA (1-866-663-3762)
Emergency
8:00AM uses
- 8:00PM ofMonday-Friday
EST, the vaccine have not been approved or licensed by the FDA, but
(nothave beenHolidays)
including authorized by the FDA, under an Emergency Use Authorization (EUA) to
prevent Coronavirus Disease 2019 (COVID-19). The Moderna COVID-19 Vaccine is
MedInfo@modernatx.com
authorized in individuals 6 months of age and older as a primary series. The Moderna
COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals 6 months
through 5 years of age at least 2 months a�er the Moderna COVID-19 Vaccine primary
series and is authorized in individuals 6 years of age and older at least 2 months a�er
any authorized or approved vaccine.
The EUA for these products is in e�ect for the duration of the COVID-19 EUA declaration
justifying emergency use of the product, unless the declaration is terminated or the
© 2023 Moderna US-COV-2200381 03/2023
authorization is revoked sooner.
Privacy Policy Terms of Use
For more information on the EUA authorized uses of the vaccine, refer to the Vaccine
Fact Sheets for Recipients and Caregivers.
What should you mention to the vaccination provider before you or your child gets
these vaccines?
Tell your vaccination provider about all medical conditions, including if you or your child:
have a fever
are immunocompromised or are on a medicine that a�ects your or your child’s immune
system
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