MODERNA COVID VACCINE

VACCINE INFORMATION SHEET (VIS)

Revised: 12/2020

FACT SHEET FOR RECIPIENTS AND CAREGIVERSEMERGENCY 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,1month 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 preventCOVID-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: 12/2020

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 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 breast feeding •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 NOTGET 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:

  1. Messenger ribonucleic acid (mRNA),

  2. Lipids (SM-102, polyethylene glycol [PEG]2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]),

  3. Tromethamine,

  4. Tromethamine Hydrochloride,

  5. Acetic Acid,

  6. Sodium Acetate, and

  7. 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.

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

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 1month apart. The duration of protection against COVID-19 is currently unknown.

Revised: 12/20203

WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE? Side effects that have been reported 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. 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 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. 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 “Moderna COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Moderna TX, 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

.Revised: 12/20204

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 PREGNANT OR BREAST FEEDING? 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.

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:

www.modernatx.com/covid19vaccine-eua

Telephone number 1-866-MODERNA (1-866-663-3762)

HOW CAN I LEARN MORE? •Ask the vaccination provider •Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.htm 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

Revised: 12/20205

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

WHAT IS THE COUNTER MEASURES INJURY COMPENSATION PROGRAM? The Counter measures 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 with in 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 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).

©2020 Moderna TX, Inc. All rights reserved. Patent(s): www.modernatx.com/patents Revised: 12/2020


PFIZER BIONTECH COVID VACCINE

VACCINE INFORMATION SHEET (VIS) Revised: December 2020

FACT SHEET FOR RECIPIENTS AND CARE GIVERS EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONA VIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 16 YEARS OF AGE AND OLDER

You are being offered the Pfizer-BioNTech 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 Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.

The Pfizer-BioNTech 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 Pfizer-BioNTech COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. 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. This type of corona virus 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 2to14days 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 PFIZER-BIONTECH COVID-19 VACCINE? The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19. Revised: December 2020. The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 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 PFIZER-BIONTECHCO VID-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 immune-compromised 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 PFIZER-BIONTECH COVID-19 VACCINE? FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older.

WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE? 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.

WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE? The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients:

  1. mRNA,

  2. 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),

  3. Potassium chloride,

  4. Monobasic potassium phosphate,

  5. Sodium chloride,

  6. Dibasic sodium phosphate dihydrate, and

  7. Sucrose.

HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN? The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle. The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.

HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE? The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16years of age and older have received at least 1dose of the Pfizer-BioNTech COVID-19 Vaccine.

WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE? In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech 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 911, or go to the nearest hospital. Revised: December 2020. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Complete and submit reports to VAERS online athttps://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call1-800-822-7967.

Please include “Pfizer-BioNTech COVID-19 Vaccine EUA” 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 www.pfizersafetyreporting.com

Fax number :1-866-635-8337

Telephone number :1-800-438-1985

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-19vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe

WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE? It is your choice to receive or not receive the Pfizer-BioNTech 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 PFIZER-BIONTECH COVID-19 VACCINE? Currently, there is no 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 PFIZER-BIONTECH COVID-19 VACCINE WITH OTHER VACCINES? There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

WHAT IF I AM PREGNANT OR BREAST FEEDING? If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19? No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

Revised: December 2020

KEEP YOUR VACCINATION CARD: When you get your first dose, you will get a vaccination card to show you when to return for your second dose of Pfizer-BioNTech 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. Global website: www.cvdvaccine.com Telephone Number: 1-877-829-2619(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.

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

WHAT IS THE COUNTER MEASURES 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 1-855-266-2427.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? The United States FDA has made the Pfizer-BioNTech 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 (Revised: December 2020) justify the emergency use of drugs and biological products during the COVID-19 pandemic. The Pfizer-BioNTech 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, 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.

The EUA for the Pfizer-BioNTech 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). Manufactured by Pfizer Inc., New York, NY 10017 Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany LAB-1451-1.

Revised: December 2020