Document text
PFIZER
Pfizer-BioNTech COVID -19 Vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0378
877-829-2619 (877-VAX -CO19)
PP-CVV-USA-0378_Pfizer-BioNTech Covid-19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 1 of 6
Confidential Pfizer document - for internal use only.
Reproduction and/or distribution of this document for any purpose without express written consent from Pfizer is proh bited. Topic Script Verbiage and Logic
1.0 Live Operator Script Welcome for PP-CVV- USA -0303
1.0 Welcome 1.1 Good (Morning/Afternoon/Evening) and thank you for calling the customer service
center for the Pfizer -BioNTech COVID -19 vaccine, also known as COMIRNATY®
(COVID -19 Vaccine, mRNA)*.
*The licensed COMIRNATY® vaccine has the same formulation as the authorize d
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.
My name is . How may I help you today?
Before we continue, I need to share the following important safety information with
you…
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 Emergency Use Authorization (EUA) to be
administered for emergency use to:
o prevent COVID -19 in individuals 12 through 15 years, and
o provide a third dose to individuals 12 years of age and older who
have been determined to have certain kinds of
immunocompromise
The Pfizer -BioNTech COVID -19 Vaccine has received EUA from FDA to:
• prevent COVID -19 in individuals 12 years of age and older, and
• provide a third dose to individuals 12 years of age and older who have
been determined to have certain kinds of immunocompromise
The FDA -approved COMIRNATY ® (COVID -19 Vaccine, mRNA) and the EUA-
authorized Pfizer -BioNTech COVID -19 Vaccine have the same formulation and
can be used interchangeably to provide the COVID- 19 vaccination series. An
individual may be offered either COMIRNATY ® (COVID -19 Vaccine, mRNA) or
the Pfizer -BioNTech COVID -19 Vaccine to prevent coronavirus disease 2019
(COVID -19) caused by SARS -CoV-2.
The emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID -19) for use in individuals
12 years of age and older; and the emergency use of this product is 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. This is an update to PP -CVV-
USA-0303, Section 1.0
Greeting. Only the updated
section has been submitted.
Please see live operator map
on page 7 for a detailed
explanation of the section that
has been updated and PP -
CVV-USA -0303 for the
remaining pages. PP -CVV -
USA-0303 has been submitted
to CBER with copy to APLB on
08/04/2021
FDA-CBER-2021-5683-0951443
PFIZER
Pfizer-BioNTech COVID -19 Vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0378
877-829-2619 (877-VAX -CO19)
PP-CVV-USA-0378_Pfizer-BioNTech Covid-19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 2 of 6
Confidential Pfizer document - for internal use only.
Reproduction and/or distribution of this document for any purpose without express written consent from Pfizer is proh bited. You should not get the Pfizer -BioNTech COVID -19 Vaccine if you:
• 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 of your medical conditions, including if you:
• 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 your
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 one
hour after getting a dose of the vaccine. For this reason, your vaccination
provider may ask you to stay at the place where you received your
vaccine for monitoring after vaccination
▪ Signs of a severe allergic reaction can include difficulty
breathing, swelling of your face and throat, a fast heartbeat, a
bad rash all over your body, dizziness, and weakness
▪ If you experience a severe allergic reaction, 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 vacc ine. 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. You
should seek medical attention right away if you have any of the
following symptoms after receiving the vaccine:
▪ chest pain
FDA-CBER-2021-5683-0951444
PFIZER
Pfizer-BioNTech COVID -19 Vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0378
877-829-2619 (877-VAX -CO19)
PP-CVV-USA-0378_Pfizer-BioNTech Covid-19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 3 of 6
Confidential Pfizer document - for internal use only.
Reproduction and/or distribution of this document for any purpose without express written consent from Pfizer is proh bited. ▪ shortness of breath
▪ feelings of having a fast-beating, fluttering, or pounding heart
• 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); diarrhea; vomiting; arm pain
• These may not be all the possible side effects of the vaccine. Serious and
unexpected side effects may occur. The vaccine is still being studied in
clinical trials. Call the vaccination provider or your healthcare provider if
you have any side effects that bother you or do not go away
There is no information on the use of this vaccine with other vaccines.
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 http://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.
Please visit www.comirnaty.com for full Prescribing Information (16+ years of age)
and Recipient and Caregiver Fact Sheet (12+ years of age).
PP-CVV -USA-0378-01
FDA-CBER-2021-5683-0951445
PFIZER
Pfizer-BioNTech COVID -19 Vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0378
877-829-2619 (877-VAX -CO19)
PP-CVV-USA-0378_Pfizer-BioNTech Covid-19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 4 of 6
Confidential Pfizer document - for internal use only.
Reproduction and/or distribution of this document for any purpose without express written consent from Pfizer is proh bited. 1.0 IVR Script Welcome for PP -CVV-USA -0304
1.1 Welcome Transfers from Pfizer Trade IVR for PP -CVV-USA -0304
1.0
1. 1 Welcome Thank you for calling the customer service center for the Pfizer -BioNTech
COVID -19 Vaccine, also known as COMIRNATY® (COVID- 19 Vaccine,
mRNA)*.
*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.
Before we continue, I need to share the following important safety information
with you…
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 Emergency Use Authorization (EUA) to be
administered for emergency use to:
▪ prevent COVID -19 in individuals 12 through 15 years, and
▪ provide a third dose to individuals 12 years of age and older
who have been determined to have certain kinds of
immunocompromise
The Pfizer -BioNTech COVID -19 Vaccine has received EUA from FDA to:
• prevent COVID -19 in individuals 12 years of age and older, and
• provide a third dose to individuals 12 years of age and older who have
been determined to have certain kinds of immunocompromise
The FDA -approved COMIRNATY ® (COVID -19 Vaccine, mRNA) and the EUA -
authorized Pfizer -BioNTech COVID -19 Vaccine have the same formulation and
can be used interchangeably to provide the COVID- 19 vaccination series. An
individual may be offered either COMIRNATY ® (COVID -19 Vaccine, mRNA) or
the Pfizer -BioNTech COVID -19 Vaccine to prevent coronavirus disease 2019
(COVID -19) caused by SARS -CoV-2.
The eme
rgency use of the product has not been approved or licensed by FDA,
but has been authorized by FDA, under an Emergency Use Authorization (EUA)
to prevent Coronavirus Disease 2019 (COVID -19) for use in individuals 12 years
of age and older; and the emergency use of this product is 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.
This is an update to PP -CVV-
USA-0304, Section 1.0
Welcome and Section 1.1
Welcome Transfers from Pfizer
Trade IVR. Only the updated
sections have been submitted.
Please see IVR map on page
8 for a detailed explanation of
the section that has been
updated and PP -CVV -USA -
0304 for the remaining pages.
PP-CVV -USA -0304 has been
submitted to CBER with copy
to APLB on 08/04/2021
FDA-CBER-2021-5683-0951446
PFIZER
Pfizer-BioNTech COVID -19 Vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0378
877-829-2619 (877-VAX -CO19)
PP-CVV-USA-0378_Pfizer-BioNTech Covid-19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 5 of 6
Confidential Pfizer document - for internal use only.
Reproduction and/or distribution of this document for any purpose without express written consent from Pfizer is proh bited.
You should not get the Pfizer -BioNTech COVID -19 Vaccine if you:
• 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 of your medical conditions, including if you:
• 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 your
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 reactio n
▪ A severe allergic reaction would usually occur within a few
minutes to one hour after getting a dose of the vaccine.
For this reason, your vaccination provider may ask you to
stay at the place where you received your vaccine for
monitoring after vaccination
▪ Signs of a severe allergic reaction can include difficulty
breathing, swelling of your face and throat, a fast
heartbeat, a bad rash all over your body, dizziness, and
weakness
▪ If you experience a severe allergic reaction, 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 vacc ine. 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. You
should seek medical attention right away if you have any of the
following symptoms after receiving the vaccine:
▪ chest pain
FDA-CBER-2021-5683-0951447
PFIZER
Pfizer-BioNTech COVID -19 Vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0378
877-829-2619 (877-VAX -CO19)
PP-CVV-USA-0378_Pfizer-BioNTech Covid-19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 6 of 6
Confidential Pfizer document - for internal use only.
Reproduction and/or distribution of this document for any purpose without express written consent from Pfizer is proh bited.
▪ shortness of breath
▪ feelings of having a fast-beating, fluttering, or pounding heart
• 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); diarrhea; vomiting; arm pain.
• These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in
clinical trials. Call the vaccination provider or your healthcare provider if
you have any side effects that bother you or do not go away
There is no information on the use of this vaccine with other vaccines.
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 http://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.
Please visit www.comirnaty.com for full Prescribing Information (16+ years of age)
and Recipient and Caregiver Fact Sheet (12+ years of age).
PP-CVV-USA-0378 -02
FDA-CBER-2021-5683-0951448
FDA-CBER-2021-5683-0951449
FDA-CBER-2021-5683-0951450