Document text
PFIZER
COVID -19 vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0426
877-829-2619 (877-VAX -CO19)
PP-CVV-USA -0426_Pfizer -BioNTech Covid -19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 1 of 8
Confidential Pfizer document - for internal use only.
Reproduction and/or distr bution of this document for any purpose without express written consent from Pfizer is prohibited.
1.0 Live Operator Script Welcome for PP-CVV -USA- 0303
1.0 New Greeting
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 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.
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 12 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.
My name is . How may I help you today?
Before we continue, I need to share the following important safety information with
you…
INDICATION & AUTHORIZED USE
HOW IS THE VACCINE GIVEN?
The vaccine will be given to you as an injection into the muscle.
Primary Series: The vaccine is administered as a 2-dose series, 3 weeks apart. A third
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 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 whose frequent institutional or occupational exposure to SARS -CoV -2 puts them at high risk of serious complications of
COVID -19 including severe COVID‑ 19
WHAT IS THE INDICATION AND AUTHORIZED USE?
The FDA -approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the FDA -
authorized Pfizer -BioNTech COVID-19 Vaccine under Emergency Use Authorization
(EUA) have the same formulation and can be used interchangeably to provide the COVID -19 vaccination 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 al so authorized under EUA to provide: This is an update to PP -CVV-
USA-0303, Section 1.0
Greeting and replaces PP -
CVV-USA -0378-01 Section
1.0. 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 a copy to APLB on 08/04/2021
FDA-CBER-2021-5683-0951793
PFIZER
COVID -19 vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0426
877-829-2619 (877-VAX -CO19)
PP-CVV-USA -0426_Pfizer -BioNTech Covid -19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 2 of 8
Confidential Pfizer document - for internal use only.
Reproduction and/or distr bution of this document for any purpose without express written consent from Pfizer is prohibited.
• a two -dose primary series in individuals 12 through 15 years
• a third primary series dose in individuals 12 years of age and older
who have been determined to have certain kinds of immunocompromise
• a single booster dose in individuals:
o 65 years of age and older
o 18 through 64 years of age at high risk of severe COV ID-19
o 18 through 64 years of age whose frequent institutional or occupational exposure to SARS -CoV -
2 puts them at high risk
of serious complications of COVID-19 including severe
COVID ‑19
The Pfizer -BioNTech COVID-19 Vaccine has received EUA from FDA to pr ovide:
• a two-dose primary series in individuals 12 years of age and older
• a third primary series dose for individuals 12 years of age and older who have
been determined to have certain kinds of immunocompromise
• a single booster dose in 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 whose frequent institutional or occupational exposure to SARS -CoV -2 puts them at high risk of
serious complications of COVID-19 including severe COVI D‑19
IMPORTANT SAFETY INFORMATION
You should not get the 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
FDA-CBER-2021-5683-0951794
PFIZER
COVID -19 vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0426
877-829-2619 (877-VAX -CO19)
PP-CVV-USA -0426_Pfizer -BioNTech Covid -19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 3 of 8
Confidential Pfizer document - for internal use only.
Reproduction and/or distr bution of this document for any purpose without express written consent from Pfizer is prohibited.
• 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. You should seek medical attention right away if you 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
• 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 vac cine
are 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
Data on administration of this vaccine at the same time as other vaccines have not ye t
been submitted to FDA. If you are considering receiving this vaccine with other vaccines, discuss your options with your 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
http://www.vaers.hhs.gov or call 1 ‑800 ‑822 ‑7967. In addit ion, you can report side
effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
For the most recent full Prescribing Information (16 + years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age) , and Recipient s and Caregiver s Fact
Sheet (12 + years of age) please visit www.Comirnaty.com
PP-CVV -USA -0426- 01
FDA-CBER-2021-5683-0951795
PFIZER
COVID -19 vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0426
877-829-2619 (877-VAX -CO19)
PP-CVV-USA -0426_Pfizer -BioNTech Covid -19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 4 of 8
Confidential Pfizer document - for internal use only.
Reproduction and/or distr bution of this document for any purpose without express written consent from Pfizer is prohibited.
1.0 IVR Script Welcome and 1.1 Welcome Transfers from Pfizer Trade IVR for PP-CVV -0304
New Greeting
callrecording
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.
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 12 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.
Before we continue, I need to share the following important safety information with
you…
INDICATION & AUTHORIZED USE
HOW IS THE VACCINE GIVEN?
The vaccine will be given to you as an injection into the muscle.
Primary Series: The vaccine is administered as a 2- dose series, 3 weeks apart. A third
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 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 whose frequent institutional or occupational exposure to SARS -CoV -2 puts them at high risk of serious complications of
COVID -19 including severe COVID‑ 19
WHAT IS THE INDICATION AND AUTHORIZED USE?
The FDA -approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the FDA -
authorized Pfizer -BioNTech COVID-19 Vaccine under Emergency Use Authorization
(EUA) have the same formulation and can be used interchangeably to provide the COVID -19 vaccination 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 two-dose primary series in individuals 12 through 15 years
• a third primary series dose in individuals 12 years of age and older
who have been determined to have certain kinds of
immunocompromise This is an update to PP -CVV-
USA-0304, Section 1.0
Welcome and 1.1 Welcome
Transfers from Pfizer Trade
IVR and replaces PP -CVV -
USA-0378-02 Section 1.0 IVR
Script Welcome and 1.1 Welcome Transfers from Pfizer Trade IVR for PP -CVV -USA -
0304. Only the updated section has been submitted. Please see live operator 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 a copy to APLB on 08/04/2021
FDA-CBER-2021-5683-0951796
PFIZER
COVID -19 vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0426
877-829-2619 (877-VAX -CO19)
PP-CVV-USA -0426_Pfizer -BioNTech Covid -19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 5 of 8
Confidential Pfizer document - for internal use only.
Reproduction and/or distr bution of this document for any purpose without express written consent from Pfizer is prohibited.
• a single booster dose in individuals:
o 65 years of age and older
o 18 through 64 years of age at high risk of severe COVID-19
o 18 through 64 years of age whose frequent institutional or
occupational exposure to SARS -CoV -2 puts them at high risk
of serious complications of COVID-19 including severe
COVID ‑19
The Pfizer -BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
• a two-dose primary series in individuals 12 years of age and older
• a third primary series dose for individuals 12 years of age and older who have
been determined to have certain kinds of immunocompromise
• a single booster dose in 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 whose frequent institutional or occupational exposure to SARS -CoV -2 puts them at high risk of
serious complications of COVID-19 including severe COVID‑ 19
IMPORTANT SAFETY INFORMATION
You should not get the 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 vaccine. In most of these people, symptoms began within a few
FDA-CBER-2021-5683-0951797
PFIZER
COVID -19 vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings
PP-CVV -USA-0426
877-829-2619 (877-VAX -CO19)
PP-CVV-USA -0426_Pfizer -BioNTech Covid -19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 6 of 8
Confidential Pfizer document - for internal use only.
Reproduction and/or distr bution of this document for any purpose without express written consent from Pfizer is prohibited.
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
• 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); 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 your healthcare provider if you have any side effects that bother you or do not go
away
Data on administration of this vaccine at the same time as other vaccines have not yet
been submitted to FDA. If you are considering receiving this vaccine with other vaccines, discuss your options with your 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
http://www.vaers.hhs.gov or call 1 ‑800 ‑822 ‑7967. In addit ion, you can report side
effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
For the most recent full Prescribing Information (16 + years of age), EUA Fact Sheet
for Vaccination Providers (12+ years of age) , and Recipients and Caregivers Fact
Sheet (12 + years of age) please visit www.Comirnaty.com
PP-CVV -USA -0426- 02
FDA-CBER-2021-5683-0951798
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Pfizer -BioNTech COVID -19 Vaccine IVR Script
PP-CVV-USA- 0303
877-829-2619 (877-VAX-CO19)
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877- 829-2619 (877 -VAX-CO19)
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Pfizer -BioNTech COVID -19 Vaccine IVR Script
PP-CVV-USA- 0304
877-829-2619 (877-VAX-CO19)
HCP
Consumer
FDA-CBER-2021-5683-0951800