>>52590, >>52576 pb

COVID-19 Vaccine: What is an Emergency Use Authorization (EUA)?

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

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Are the COVID-19 vaccines rigorously tested?

Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.

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What are the plans for continued monitoring of COVID-19 vaccines authorized by FDA for emergency use?

FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA.

FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval).

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

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>>52590, >>52576

FDA FACT SHEET for Healthcare Providers and Moderna Covid-19 FACT SHEET for Recipients

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)EMERGENCY USE AUTHORIZATION (EUA) OFTHE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.modernatx.com/covid19vaccine-eua to obtain the Fact Sheet) prior to the individual receiving the Moderna COVID-19 Vaccine, including:

•FDA has authorized the emergency use of the Moderna COVID-19 Vaccine, which is not an FDA-approved vaccine.

•The recipient or their caregiver has the option to accept or refuse the Moderna COVID-19 Vaccine.

•The significant known and potential risks and benefits of the Moderna COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.•Information about available alternative vaccines and the risks and benefits of those alternatives

https://www.fda.gov/media/144637/download

MODERNA COVID-19 VACCINE FACT SHEET

Revised: 12/20201

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 visitwww.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: 12/20202 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 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.

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https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf

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>>54345 >>52590, >>52576

FDA FACT SHEET for Healthcare Providers and Moderna Covid-19 FACT SHEET for Recipients

cont...

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]2000dimyristoylglycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, 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.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 olderhave 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 lymphnodes 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 ModernaTX, Inc.at 1-866-MODERNA (1-866-663-3762).You may also be given an option to enroll in v-safe. V-safeis 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.

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https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf

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cont...

FDA FACT SHEET for Healthcare Providers and Moderna Covid-19 FACT SHEET for Recipients

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 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.

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 websiteTelephone number www.modernatx.com/covid19vaccine-eua1-866-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.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

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 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 1-855-266-2427. 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 ModernaTX, Inc.All rights reserved.Patent(s): www.modernatx.com/patentsRevised: 12/2020

https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf

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FACT SHEET for PFIZER-BIONTECH COVID-19 VACCINE

COVID-19 Vaccine: What is an Emergency Use Authorization (EUA)?

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

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Accessed 2/6/21

1 Revised: January 2021

FACT SHEET FOR RECIPIENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OFTHE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS 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 weeksapart, 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 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 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.

2 Revised: January 2021

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.

cont...

https://www.fda.gov/media/144414/download

>>54354

FACT SHEET Pfizer-BioNTech COVID-19 Vaccine

cont…

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE PFIZER-BIONTECH 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

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: 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.

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 weeksapart. 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 16 years of age and older have received at least 1 dose 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?Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: •injection site pain•tiredness•headache•muscle pain •chills•joint pain•fever•injection site swelling•injection site redness•nausea•feeling unwell•swollen lymph nodes (lymphadenopathy)There is a remote chance that the Pfizer-BioNTech 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 Pfizer-BioNTech 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 weaknessThese 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 9-1-1, or go to the nearest hospital.

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https://www.fda.gov/media/144414/download

>>54354, >>54355

FACT SHEET Pfizer-BioNTech COVID-19 Vaccine

cont…

4 Revised: January 2021

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/CDCVaccine Adverse Event Reporting System(VAERS). The VAERS toll-free number is1- 800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. 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 Fax number Telephone numberwww.pfizersafetyreporting.com1- 866-635-83371- 800-438-1985You 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 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 BREASTFEEDING?If you are pregnant or breastfeeding, discuss your options with your healthcare provider. WILL THE PFIZER-B IONTECH 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.

5 Revised: January 2021

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 websiteTelephone numberwww.cvdvaccine.com1- 877-829-2619(1-877-VAX-CO19)

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https://www.fda.gov/media/144414/download

>>54354, >>54355, >>54357

FACT SHEET Pfizer-BioNTech COVID-19 Vaccine

cont…

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 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 1-855-266-2427.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

6 Revised: January 2021justify 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, unlessterminated or revoked (after which the products may no longer be used).

Manufactured byPfizer Inc., New York, NY 10017 Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, GermanyLAB-1451-1.1 Revised: January 2021

https://www.fda.gov/media/144414/download>>54354