Burk Declaration

Summary

Document 40-18, filed December 17, 2021 in Case 2:21-cv-00702-CLM in the U.S. District Court, N.D. of Alabama, is Exhibit 18 to the Burk Declaration. The exhibit is the Fact Sheet for Recipients and Caregivers on the Emergency Use Authorization of the Janssen COVID-19 Vaccine for individuals 18 years of age and older. It describes the single-dose primary vaccination and booster doses, the vaccine's ingredients, and reported side effects including blood clots with low levels of platelets and Guillain Barré syndrome. It also covers reporting side effects to VAERS, v-safe, the Countermeasures Injury Compensation Program, and what an Emergency Use Authorization is.

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Case 2:21-cv-00702-CLM Document 40-18 Filed 12/17/21 Page 1 of 9            FILED
                                                                   2021 Dec-17 PM 01:27
                                                                   U.S. DISTRICT COURT
                                                                       N.D. OF ALABAMA




              Burk Declaration
                 Exhibit 18
        Case 2:21-cv-00702-CLM Document 40-18 Filed 12/17/21 Page 2 of 9


                  FACT SHEET FOR RECIPIENTS AND CAREGIVERS

              EMERGENCY USE AUTHORIZATION (EUA) OF
THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019
        (COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER

You are being offered the Janssen COVID-19 Vaccine to prevent Coronavirus Disease 2019
(COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you
understand the risks and benefits of receiving the Janssen COVID-19 Vaccine, which you may
receive because there is currently a pandemic of COVID-19.

The Janssen COVID-19 Vaccine may prevent you from getting COVID-19.

Read this Fact Sheet for information about the Janssen COVID-19 Vaccine. Talk to the vaccination
provider if you have questions. It is your choice to receive the Janssen COVID-19 Vaccine.

The Janssen COVID-19 Vaccine has received EUA from FDA to provide:

•   A single dose primary vaccination to individuals 18 years of age and older.

•   A single booster dose to individuals 18 years of age and older who have completed a primary
    vaccination with Janssen COVID-19 Vaccine.

•   A single booster dose to eligible individuals who have completed primary vaccination with a
    different authorized or approved COVID-19 vaccine.

The Janssen COVID-19 Vaccine may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit
www.janssencovid19vaccine.com.

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

WHAT IS COVID-19?

COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been
seen before. 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. Symptoms
may appear 2 to 14 days after exposure to the virus. Common symptoms may include: fever or
chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or
smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19.


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The FDA has authorized the emergency use of the Janssen COVID-19 Vaccine to prevent
COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization
(EUA).

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 JANSSEN COVID-19 VACCINE?

Tell the vaccination provider about all of your medical conditions, including if you:

•   have any allergies,

•   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 or plan to become pregnant,

•   are breastfeeding,

•   have received another COVID-19 vaccine,

•   have ever fainted in association with an injection.
WHO SHOULD GET THE JANSSEN COVID-19 VACCINE?

FDA has authorized the emergency use of the Janssen COVID-19 Vaccine in individuals 18 years
of age and older.

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?

You should not get the Janssen 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.
WHAT ARE THE INGREDIENTS IN THE JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine includes the following ingredients: recombinant,
replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid
monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD),
polysorbate-80, sodium chloride.




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HOW IS THE JANSSEN COVID -19 VACCINE GIVEN?

The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle.

Primary Vaccination: The Janssen COVID-19 Vaccine is administered as a single dose.

Booster Dose:

•   A single booster dose of the Janssen COVID-19 Vaccine may be administered at least two
    months after primary vaccination with the Janssen COVID-19 Vaccine.

•   A single booster dose of the Janssen COVID-19 Vaccine may be administered to eligible
    individuals who have completed primary vaccination with a different authorized or approved
    COVID-19 vaccine. Please check with your health care provider regarding eligibility for and
    timing of the booster dose.

HAS THE JANSSEN COVID-19 VACCINE BEEN USED BEFORE?

The Janssen COVID-19 Vaccine is an unapproved vaccine. In clinical trials, more than 61,000
individuals 18 years of age and older have received at least 1 dose of the Janssen COVID-19
Vaccine. Millions of individuals have received the vaccine under EUA since February 27, 2021.

WHAT ARE THE BENEFITS OF THE JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine has been shown to prevent COVID-19. The duration of protection
against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?

Side effects that have been reported with the Janssen COVID-19 Vaccine include:

•   Injection site reactions: pain, redness of the skin and swelling.

•   General side effects: headache, feeling very tired, muscle aches, nausea, and fever.

•   Swollen lymph nodes.

•   Blood clots.

•   Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling
    or sensitivity, especially in the skin (hypoesthesia).

•   Persistent ringing in the ears (tinnitus).

•   Diarrhea, vomiting.

Severe Allergic Reactions
There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic
reaction. A severe allergic reaction would usually occur within a few minutes to one hour after

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getting a dose of the Janssen COVID-19 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.
Blood Clots with Low Levels of Platelets
Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of
platelets (blood cells that help your body stop bleeding), have occurred in some people who have
received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels
of platelets, symptoms began approximately one to two weeks after vaccination. Reporting of these
blood clots and low levels of platelets has been highest in females ages 18 through 49 years. The
chance of having this occur is remote.

You should seek medical attention right away if you have any of the following symptoms after
receiving the Janssen COVID-19 Vaccine:

•   Shortness of breath,

•   Chest pain,

•   Leg swelling,

•   Persistent abdominal pain,

•   Severe or persistent headaches or blurred vision,

•   Easy bruising or tiny blood spots under the skin beyond the site of the injection.
These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and
unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical
trials.

Guillain Barré Syndrome
Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages
nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who
have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within
42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is




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very low. You should seek medical attention right away if you develop any of the following
symptoms after receiving the Janssen COVID-19 Vaccine:

•     Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading
      to other parts of the body.

•     Difficulty walking.

•     Difficulty with facial movements, including speaking, chewing, or swallowing.

•     Double vision or inability to move eyes.

•     Difficulty with bladder control or bowel function.

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 “Janssen COVID-19 Vaccine EUA” in the
first line of box #18 of the report form.

In addition, you can report side effects to Janssen Biotech, Inc. at the contact information provided
below.

               e-mail                      Fax number                   Telephone numbers
    JNJvaccineAE@its.jnj.com               215-293-9955             US Toll Free: 1-800-565-4008
                                                                      US Toll: (908) 455-9922

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based
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 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.

WHAT IF I DECIDE NOT TO GET THE JANSSEN COVID-19 VACCINE?

It is your choice to receive or not receive the Janssen COVID-19 Vaccine. Should you decide not
to receive it, it will not change your standard medical care.




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ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES
JANSSEN COVID-19 VACCINE?

Another choice for preventing COVID-19 is Comirnaty, an FDA-approved COVID-19 vaccine.
Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

CAN I RECEIVE THE JANSSEN COVID-19 VACCINE AT THE SAME TIME AS
OTHER VACCINES?

Data have not yet been submitted to FDA on administration of the Janssen COVID-19 Vaccine at
the same time as other vaccines. If you are considering receiving the Janssen COVID-19 Vaccine
with other vaccines, discuss your options with your healthcare provider.

WHAT IF I AM PREGNANT OR BREASTFEEDING?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

WILL THE JANSSEN COVID-19 VACCINE GIVE ME COVID-19?

No. The Janssen COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you
COVID-19.

KEEP YOUR VACCINATION CARD

When you receive the Janssen COVID-19 Vaccine, you will get a vaccination card to document
the name of the vaccine and date of when you received the vaccine.

ADDITIONAL INFORMATION

If you have questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan
the QR code using your device, visit the website or call the telephone numbers provided below.

       QR Code                  Fact Sheets Website                    Telephone numbers
                           www.janssencovid19vaccine.com.          US Toll Free: 1-800-565-4008
                                                                     US Toll: (908) 455-9922




HOW CAN I LEARN MORE?

•   Ask the vaccination provider.

•   Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.

•   Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
    regulatory-and-policy-framework/emergency-use-authorization.
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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. 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, HRSA COVID-19 Uninsured Program for non-insured
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 TIPS.HHS.GOV.

WHAT IS THE COUNTERMEASURE 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 for certain people who have been
seriously injured by certain medicines or vaccines, including this 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)?

The United States FDA has made the Janssen COVID-19 Vaccine available under an emergency
access mechanism called an EUA. The 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.

The Janssen COVID-19 Vaccine has not undergone the same type of review as an FDA-approved
or cleared 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 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.

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