ModernaTX, Inc. et al v. Pfizer Inc. et al

Filing 1

COMPLAINT against BioNTech US Inc., BioNTech SE, Pfizer Inc., BioNTech Manufacturing GmbH Filing fee: $ 402, receipt number AMADC-9469742 (Fee Status: Filing Fee paid), filed by Moderna US, Inc., ModernaTX, Inc.. (Attachments: #1 Exhibit 1, #2 Exhibit 2, #3 Exhibit 3, #4 Exhibit 4, #5 Exhibit 5, #6 Exhibit 6, #7 Exhibit 7, #8 Exhibit 8, #9 Exhibit 9, #10 Civil Cover Sheet, #11 Category Form)(Lee, William)

EXHIBIT 

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS
ABOUT COMIRNATY (COVID-19 VACCINE, mRNA)
AND THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND
OLDER

FOR 12 YEARS OF AGE AND OLDER

You are being 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.
This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the
Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and also
includes information about the U.S. Food and Drug Administration
(FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in
individuals 12 years of age and older1.
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the
Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use
Authorization (EUA) for individuals 12 years of age and older, when prepared
according to their respective instructions for use, can be used interchangeably. 2
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 12 years of age and older. It is also
authorized under EUA to provide:
x a third primary series dose to individuals 12 years of age and older with
certain kinds of immunocompromise;
x a first booster dose to individuals 12 years of age and older who have
completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY (COVID-19 Vaccine, mRNA);
x a first booster dose to individuals 18 years of age and older who have
completed primary vaccination with another authorized or approved

You may receive this Vaccine Information Fact Sheet even if your child is 11 years old. Children who
will turn from 11 years to 12 years of age between doses in the primary regimen may receive, for any
dose in the primary regimen, either: (1) the Pfizer-BioNTech COVID-19 Vaccine authorized for use in
individuals 5 through 11 years of age; or (2) COMIRNATY (COVID-19 Vaccine, mRNA) or the PfizerBioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older.
2
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY
(COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals
12 years of age and older can be used interchangeably without presenting any safety or effectiveness
concerns.
1

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x
x

COVID-19 vaccine. The booster schedule is based on the labeling
information of the vaccine used for the primary series;
a second booster dose to individuals 50 years of age and older who
have received a first booster dose of any authorized or approved
COVID-19 vaccine; and
a second booster dose to individuals 12 years of age and older with
certain kinds of immunocompromise and who have received a first
booster dose of any authorized or approved COVID-19 vaccine.

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to
provide:
x a 2-dose primary series to individuals 12 years of age and older;
x a third primary series dose to individuals 12 years of age and older with
certain kinds of immunocompromise;
x a first booster dose to individuals 12 years of age and older who have
completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY (COVID-19 Vaccine, mRNA);
x a first booster dose to individuals 18 years of age and older who have
completed primary vaccination with another authorized or approved
COVID-19 vaccine. The booster schedule is based on the labeling
information of the vaccine used for the primary series;
x a second booster dose to individuals 50 years of age and older who
have received a first booster dose of any authorized or approved
COVID-19 vaccine; and
x a second booster dose to individuals 12 years of age and older with
certain kinds of immunocompromise and who have received a first
booster dose of any authorized or approved COVID-19 vaccine.
This Vaccine Information Fact Sheet contains information to help you understand the
risks and benefits of COMIRNATY (COVID-19 Vaccine, mRNA) and the
Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently
a pandemic of COVID-19. Talk to your vaccination provider if you have questions.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please see
www.cvdvaccine.com.
WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE
WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. You can get
COVID-19 through contact with another person who has the virus. It is predominantly a
respiratory illness that can affect other organs. People with COVID-19 have had a wide
range of symptoms reported, ranging from mild symptoms to severe illness leading to
death. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may
include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches;

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headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or
vomiting; diarrhea.
WHAT IS COMIRNATY (COVID-19 VACCINE, mRNA) AND HOW IS IT RELATED TO
THE PFIZER-BIONTECH COVID-19 VACCINE?
COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19
Vaccine, when prepared according to their respective instructions for use, can be used
interchangeably.
For more information on EUA, see the “What is an Emergency Use Authorization
(EUA)?” section at the end of this Fact Sheet.
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE
YOU GET THE VACCINE?
Tell the vaccination provider about all of your medical conditions, including if
you:
x have any allergies
x have had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart)
x have a fever
x have a bleeding disorder or are on a blood thinner
x are immunocompromised or are on a medicine that affects your immune system
x are pregnant or plan to become pregnant
x are breastfeeding
x have received another COVID-19 vaccine
x have ever fainted in association with an injection
HOW IS THE VACCINE GIVEN?
The Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA)
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
primary series dose may be administered at least 4 weeks after the second dose to
individuals with certain kinds of immunocompromise.
Booster Dose:
x A first booster dose of the vaccine may be administered at least 5 months after
completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY (COVID-19 Vaccine, mRNA) to individuals 12 years of age and
older.

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x

x
x

A first booster dose of the vaccine may be administered to individuals 18 years
of age and older who have completed primary vaccination with another
authorized or approved COVID-19 vaccine. Please check with your healthcare
provider regarding timing of the booster dose.
A second booster dose of the vaccine may be administered to individuals 50
years of age and older at least 4 months after receipt of a first booster dose of
any authorized or approved COVID-19 vaccine.
A second booster dose of the vaccine may be administered at least 4 months
after receipt of a first booster dose of any authorized or approved COVID-19
vaccine to individuals 12 years of age and older with certain kinds of
immunocompromise.

The vaccine may not protect everyone.
WHO SHOULD NOT GET THE VACCINE?
You should not get the vaccine if you:
x had a severe allergic reaction after a previous dose of this vaccine
x had a severe allergic reaction to any ingredient of this vaccine.
WHAT ARE THE INGREDIENTS IN THE VACCINES?
COMIRNATY (COVID-19 Vaccine, mRNA) and the authorized formulations of the
vaccine include the following ingredients:
x mRNA and lipids (((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2Distearoyl-sn-glycero-3-phosphocholine, and cholesterol).
Pfizer-BioNTech COVID-19 vaccines for individuals 12 years of age and older contain
1 of the following sets of additional ingredients; ask the vaccination provider which
version is being administered:
x potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic
sodium phosphate dihydrate, and sucrose
OR
x tromethamine, tromethamine hydrochloride, and sucrose
COMIRNATY (COVID-19 Vaccine, mRNA) contains 1 of the following sets of additional
ingredients; ask the vaccination provider which version is being administered:
x potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic
sodium phosphate dihydrate, and sucrose
OR
x tromethamine, tromethamine hydrochloride, and sucrose
HAS THE VACCINE BEEN USED BEFORE?
Yes. In clinical trials, approximately 23,000 individuals 12 years of age and older have
received at least 1 dose of the vaccine. Data from these clinical trials supported the
Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccines and the
approval of COMIRNATY (COVID-19 Vaccine, mRNA). Millions of individuals have
received the vaccine under EUA since December 11, 2020. The vaccine that is
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authorized for use in individuals 12 years of age and older includes two formulations;
one that was studied in clinical trials and used under EUA, and one with the same
mRNA and lipids but different inactive ingredients. The use of the different inactive
ingredients helps stabilize the vaccine under refrigerated temperatures and the
formulation can be administered without dilution.
WHAT ARE THE BENEFITS OF THE VACCINE?
The vaccine has been shown to prevent COVID-19.
The duration of protection against COVID-19 is currently unknown.
WHAT ARE THE RISKS OF THE VACCINE?
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 1 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:
x Difficulty breathing
x Swelling of your face and throat
x A fast heartbeat
x A bad rash all over your body
x Dizziness and weakness
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,
more commonly in adolescent males and adult males under 40 years of age than
among females and older males. In most of these people, symptoms began within a
few days following receipt of the second dose of 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:
x Chest pain
x Shortness of breath
x Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with the vaccine include:
x Severe allergic reactions
x Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
x Myocarditis (inflammation of the heart muscle)
x Pericarditis (inflammation of the lining outside the heart)
x Injection site pain
x Tiredness
x Headache
x Muscle pain

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x
x
x
x
x
x
x
x
x
x
x
x
x

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.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects
that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System
(VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html. Please include either “COMIRNATY (COVID-19
Vaccine, mRNA)” or “Pfizer-BioNTech COVID-19 Vaccine EUA”, as appropriate, in the
first line of box #18 of the report form.
In addition, you can report side effects to Pfizer Inc. at the contact information provided
below.
Website

Fax number

Telephone number

www.pfizersafetyreporting.com

1-866-635-8337

1-800-438-1985

You may also be given an option to enroll in v-safe. V-safe is a voluntary smartphonebased tool that uses text messaging and web surveys to check in with people who have
been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe
asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also
provides second-dose reminders if needed and live telephone follow-up by CDC if
participants report a significant health impact following COVID-19 vaccination. For more
information on how to sign up, visit: www.cdc.gov/vsafe.

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WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR
THE PFIZER-BIONTECH COVID-19 VACCINE?
Under the EUA, it is your choice to receive or not receive the vaccine. Should you
decide not to receive it, it will not change your standard medical care.
ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES
COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19
VACCINE?
Another choice for preventing COVID-19 is SPIKEVAX, an FDA-approved COVID-19
vaccine. Other vaccines to prevent COVID-19 may be available under Emergency Use
Authorization.
CAN I RECEIVE THE COMIRNATY (COVID-19 VACCINE, mRNA) OR
PFIZER-BIONTECH COVID-19 VACCINE AT THE SAME TIME AS OTHER
VACCINES?
Data have not yet been submitted to FDA on administration of COMIRNATY
(COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine at the same
time with other vaccines. If you are considering receiving COMIRNATY (COVID-19
Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine with other vaccines,
discuss your options with your healthcare provider.
WHAT IF I AM IMMUNOCOMPROMISED?
If you are immunocompromised, you may receive a third primary series dose of the
vaccine. The third dose may still not provide full immunity to COVID-19 in people who
are immunocompromised, and you should continue to maintain physical precautions
to help prevent COVID-19. In addition, after you received a first booster dose, you
may receive a second booster dose of the vaccine if you are 12 years of age or older.
Your close contacts should be vaccinated as appropriate.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, discuss your options with your healthcare
provider.
WILL THE VACCINE GIVE ME COVID-19?
No. The vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.
KEEP YOUR VACCINATION CARD
When you get your first dose, you will get a vaccination card to show you when to
return for your next dose(s) of the vaccine. Remember to bring your card when you
return.

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ADDITIONAL INFORMATION
If you have questions, visit the website or call the telephone number provided below.
To access the most recent Fact Sheets, please scan the QR code provided below.
Global website
www.cvdvaccine.com

Telephone number
1-877-829-2619
(1-877-VAX-CO19)

HOW CAN I LEARN MORE?
x Ask the vaccination provider.
x Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
x Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization.
x Contact your local or state public health department.
WHERE WILL MY VACCINATION INFORMATION BE RECORDED?
The vaccination provider may include your vaccination information in your state/local
jurisdiction’s Immunization Information System (IIS) or other designated system. This
will ensure that you receive the same vaccine when you return for the second dose. For
more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html .
CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19
VACCINE?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be
charged an out-of-pocket vaccine administration fee or any other fee if only receiving a
COVID-19 vaccination. However, vaccination providers may seek appropriate
reimbursement from a program or plan that covers COVID-19 vaccine administration
fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health
Resources & Services Administration [HRSA] COVID-19 Uninsured Program for noninsured recipients).
WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?
Individuals becoming aware of any potential violations of the CDC COVID-19
Vaccination Program requirements are encouraged to report them to the Office of the
Inspector General, U.S. Department of Health and Human Services, at
1-800-HHS-TIPS or https://TIPS.HHS.GOV.
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?
The Countermeasures Injury Compensation Program (CICP) is a federal program that
may help pay for costs of medical care and other specific expenses of certain people
who have been seriously injured by certain medicines or vaccines, including this
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vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the
date of receiving the vaccine. To learn more about this program, visit
www.hrsa.gov/cicp/ or call 1-855-266-2427.
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
An EUA is a mechanism to facilitate the availability and use of medical products,
including vaccines, during public health emergencies, such as the current COVID-19
pandemic. An EUA is supported by a Secretary of Health and Human Services (HHS)
declaration that circumstances exist to justify the emergency use of drugs and
biological products during the COVID-19 pandemic. A product authorized for
emergency use has not undergone the same type of review by FDA as an
FDA-approved product.
FDA may issue an EUA when certain criteria are met, which includes that there are no
adequate, approved, and available alternatives. In addition, the FDA decision is based
on the totality of the scientific evidence available showing that the product may be
effective to prevent COVID-19 during the COVID-19 pandemic and that the known and
potential benefits of the product outweigh the known and potential risks of the product.
All of these criteria must be met to allow for the product to be used during the
COVID-19 pandemic.
An EUA is in effect for the duration of the COVID-19 EUA declaration justifying
emergency use of this product, unless terminated or revoked (after which the product
may no longer be used).

Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany

Manufactured by
Pfizer Inc., New York, NY 10017
LAB-1451-19.2a
Revised: 8 July 2022

Scan to capture that this Fact Sheet was provided to vaccine
recipient for the electronic medical records/immunization
information systems.
GDTI: 0886983000332

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