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*. Comirnaty and Pfizer COVID-*9 Vaccine Fact Sheet for Recipients and Caregivers 2 2. Moderna COVID-19 Vaccine Fact Sheet for Recipients and Caregivers 10 3. Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers 16 1 Revised: 22 September 2021

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA)

AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

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 FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).

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.[1]

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; and

• a single booster dose in individuals:

o 65 years of age and older

• 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; and

• a single booster dose in individuals:

o 65 years of age and older

[1] The licensed vaccine has the same formulation as the EUA-authorized 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.

2 Revised: 22 September 2021

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 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; 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 have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.1

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:

• have any allergies

• have had myocarditis (inflammation of the heart muscle) or pericarditis

(inflammation of the lining outside the heart)

• have a fever

1 The licensed vaccine has the same formulation as the EUA-authorized 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.

3 Revised: 22 September 2021

• 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 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

The vaccine may not protect everyone.

WHO SHOULD NOT GET THE VACCINE?

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. WHAT ARE THE INGREDIENTS IN THE VACCINE?

The vaccine includes the following ingredients: mRNA, lipids ((4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, 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 Vaccine and the approval of COMIRNATY (COVID-19 Vaccine, mRNA). Millions of individuals have received the vaccine under EUA since December 11, 2020. 4 Revised: 22 September 2021

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 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

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 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

5 Revised: 22 September 2021

• 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-***-**** 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-***-**** 1-800-***-**** 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 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. 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 PFIZER-BIONTECH COVID-19 VACCINE?

Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

6 Revised: 22 September 2021

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 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, 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.

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 Telephone number

www.cvdvaccine.com

1-877-***-****

(1-877-VAX-CO19)

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.

• Contact your local or state public health department. 7 Revised: 22 September 2021

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 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 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 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-***-****.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

An Emergency Use Authorization (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. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, 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 in the treatment of patients during the COVID-19 pandemic.

This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer 8 Revised: 22 September 2021

exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

Manufactured by

Pfizer Inc., New York, NY 10017

Manufactured for

BioNTech Manufacturing GmbH

An der Goldgrube 12

55131 Mainz, Germany

LAB-1451-9.3

Revised: 22 September 2021

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

Barcode Date: 08/2021

Revised: Aug/12/2021 1

FACT SHEET FOR RECIPIENTS AND CAREGIVERS

EMERGENCY USE AUTHORIZATION (EUA) OF

THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019

(COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER You are being offered the Moderna 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 the Moderna COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19. The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19. Read this Fact Sheet for information about the Moderna COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19 Vaccine.

The Moderna COVID-19 Vaccine is administered as a 2-dose series, 1 month apart, into the muscle.

The Moderna COVID-19 Vaccine may not protect everyone. This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit www.modernatx.com/covid19vaccine-eua.

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. 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 MODERNA COVID-19 VACCINE?

The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

The FDA has authorized the emergency use of the Moderna 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.

Revised: Aug/12/2021 2

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE MODERNA COVID-19 VACCINE?

Tell your 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 or plan to become pregnant

• are breastfeeding

• have received another COVID-19 vaccine

WHO SHOULD GET THE MODERNA COVID-19 VACCINE?

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

WHO SHOULD NOT GET THE MODERNA COVID-19 VACCINE?

You should not get the Moderna 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 MODERNA COVID-19 VACCINE? The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid

(mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose. HOW IS THE MODERNA COVID-19 VACCINE GIVEN?

The Moderna COVID-19 Vaccine will be given to you as an injection into the muscle. The Moderna COVID-19 Vaccine vaccination series is 2 doses given 1 month apart. If you receive one dose of the Moderna COVID-19 Vaccine, you should receive a second dose of the same vaccine 1 month later to complete the vaccination series. If you are immunocompromised, you may receive a third dose of the Moderna COVID-19 Vaccine at least 1 month after the second dose.

HAS THE MODERNA COVID-19 VACCINE BEEN USED BEFORE? The Moderna COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna COVID-19 Vaccine.

Revised: Aug/12/2021 3

WHAT ARE THE BENEFITS OF THE MODERNA COVID-19 VACCINE? In an ongoing clinical trial, the Moderna COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE? There is a remote chance that the Moderna COVID-19 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 Moderna 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

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the Moderna COVID-19 Vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the Moderna COVID-19 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 Moderna COVID-19 Vaccine:

• Chest pain

• Shortness of breath

• Feelings of having a fast-beating, fluttering, or pounding heart Side effects that have been reported in a clinical trial with the Moderna COVID-19 Vaccine include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever

Side effects that have been reported during post-authorization use of the Moderna COVID-19 Vaccine include:

• Severe allergic reactions

• Myocarditis (inflammation of the heart muscle)

• Pericarditis (inflammation of the lining outside the heart) These may not be all the possible side effects of the Moderna COVID-19 Vaccine. Serious and unexpected side effects may occur. The Moderna COVID-19 Vaccine is 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. Revised: Aug/12/2021 4

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-***-**** or report online to https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine EUA” in the first line of box #18 of the report form.

In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663- 3762).

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 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.

WHAT IF I DECIDE NOT TO GET THE MODERNA COVID-19 VACCINE? It is your choice to receive or not receive the Moderna COVID-19 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 MODERNA COVID-19 VACCINE?

Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19. Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization. CAN I RECEIVE THE MODERNA COVID-19 VACCINE WITH OTHER VACCINES? There is no information on the use of the Moderna COVID-19 Vaccine with other vaccines. WHAT IF I AM IMMUNOCOMPROMISED?

If you are immunocompromised, you may receive a third dose of the Moderna COVID-19 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, 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 MODERNA COVID-19 VACCINE GIVE ME COVID-19? No. The Moderna COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

Revised: Aug/12/2021 5

KEEP YOUR VACCINATION CARD

When you receive your first dose, you will get a vaccination card to show you when to return for your second dose of the Moderna COVID-19 Vaccine. Remember to bring your card when you return.

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. Moderna COVID-19 Vaccine website Telephone number

www.modernatx.com/covid19vaccine-eua

1-866-MODERNA

(1-866-***-****)

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

• Contact your state or local 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?

(private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).

WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?

The United States FDA has made the Moderna 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 Moderna 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 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. The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

Moderna US, Inc.

Cambridge, MA 02139

Patent(s): www.modernatx.com/patents

Revised: Aug/12/2021

Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization

Contact this candidate