COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

The U.S. Food and Drug Administration (FDA) has authorized emergency use of this vaccine to prevent COVID-19. The Novavax COVID-19 vaccine is for use in people who are at least 12 years old.

COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19. This vaccine will not treat an active COVID-19 infection.

Like any vaccine, COVID-19 vaccine may not provide protection in every person.

The U.S. Food and Drug Administration (FDA) has authorized emergency use of this vaccine to prevent COVID-19 in people 12 years and older. This vaccine has not been approved to treat COVID-19.

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

If you have a certain type of reaction after the first dose of this vaccine, your healthcare provider will determine if you can safely receive the second dose.

Read all vaccine information sheets provided to you. Follow the label directions or your vaccination provider's instructions.

Novavax COVID-19 vaccine is given as an injection (shot) into a muscle in people at least 12 years old.

For people who have already received one or more doses of any COVID-19 vaccine: a single dose of Novavax COVID-19 vaccine is given 2 months after the last dose of any COVID-19 vaccine.

For unvaccinated individuals: two doses of Novavax COVID-19 vaccine are given. The second dose is given 3 weeks after the first dose.

Additional doses of the vaccine may be given if you have a weak immune system. Your doctor will determine whether you need an additional dose.

You will receive a reminder card showing the date and type of your first injection. Take this card with you if you get an additional dose.

Even after you are fully vaccinated, this vaccine will not make you less contagious if you are already infected with COVID-19 but you have no symptoms. Keep using infection control methods when you are in public or around others who may not be vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Receiving a COVID-19 vaccine will not cause you to test positive on a coronavirus test. However, once your body develops immunity to COVID-19, you could test positive on an antibody test (a test to detect immunity in your body from previous exposure to coronavirus).

It is not known how long this vaccine will protect you from infection with COVID-19. It also is not known how long immunity will last in a person who's been infected with and recovered from COVID-19. COVID-19 vaccine is still being studied and all of its risks are not yet known. Updated federal public health recommendations may be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

Usual Adult Dose for COVID-19:

FOR INVESTIGATIONAL USE ONLY

Primary series: 0.5 mL IM for 2 doses, administered 3 weeks apart

First Booster Dose: 0.5 mL IM, at least 6 months after completing a primary series

Comments:
-This drug is not approved by the US FDA to prevent coronavirus disease 2019 (COVID-19). The US FDA has issued an Emergency Use Authorization (EUA) for the use of this drug to prevent COVID-19.
-No data are available regarding the use of this vaccine to complete a COVID-19 vaccine series initiated with another vaccine.

Use: For active immunization to prevent COVID-19 due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for whom other US FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in those who elect to receive this vaccine because they would otherwise not receive a COVID-19 vaccine

Usual Pediatric Dose for COVID-19:

FOR INVESTIGATIONAL USE ONLY

12 years and older:
-Primary series: 0.5 mL IM for 2 doses, administered 3 weeks apart

Comments:
-This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued an EUA for the use of this drug to prevent COVID-19.
-No data are available regarding the use of this vaccine to complete a COVID-19 vaccine series initiated with another vaccine.

Use: For active immunization to prevent COVID-19 due to SARS-CoV-2 for whom other US FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in those who elect to receive this vaccine because they would otherwise not receive a COVID-19 vaccine

You should not receive this vaccine if you've ever had an allergic reaction to a Novavax COVID-19 vaccine.

Your healthcare provider will determine whether any reaction you have would prevent you from safely getting the second dose.

If you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19: You may not be able to receive this vaccine until you have no symptoms and/or your required quarantine period has ended. Receiving this vaccine will not make you less contagious to other people if you are infected with COVID-19 but you have no symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you received.

Tell your vaccination provider if:

• you have a fever;

• you have any allergies;

• you have bleeding problems, or if you use a blood thinner (warfarin, Coumadin, Jantoven);

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

• you have a weak immune system caused by disease or by using certain medicine;

• you are pregnant, plan to become pregnant, or breastfeeding;

• you've received any other COVID-19 vaccine; or

• have ever fainted when or after receiving an injection.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this vaccine on the baby.

Tell your doctor if you are pregnant or breastfeeding.

Be sure to receive all recommended doses of COVID-19 vaccine or you may not be fully protected. Contact your vaccination provider or health department if you miss your dose.

An overdose of this vaccine is unlikely to occur.

Avoid receiving other vaccines without first seeking medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, confusion, dizziness, fainting, vomiting, diarrhea, fast heartbeats, wheezing, difficult breathing, swelling of your face, lips, tongue, or throat.

An allergic reaction is more likely to occur within 30 minutes after you receive the vaccine. You will be treated quickly if you have a reaction.

You should not receive another dose if the first shot caused an allergic reaction. Your healthcare provider will determine if you can safely receive the second dose.

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine. Serious side effects other than an allergic reaction may include:

• chest pain, shortness of breath, fast or pounding heartbeats.

Fever may be a normal symptom as your body begins to develop immunity to COVID-19. However, you should call your doctor right away if you have any side effects that concern you.

Common side effects of COVID-19 vaccine, Novavax (2023-2024) may include:

• fever, chills, swollen glands;

• pain, redness, or swelling where the shot was given;

• nausea, vomiting, not feeling well;

• feeling tired; or

• headache, muscle pain, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems you have after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

Warnings

The U.S. Food and Drug Administration (FDA) has authorized emergency use of this vaccine to prevent COVID-19 in people 12 years and older. This vaccine has not been approved to treat COVID-19.

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

If you have a certain type of reaction after the first dose of this vaccine, your healthcare provider will determine if you can safely receive the second dose.

Before taking this medicine

You should not receive this vaccine if you've ever had an allergic reaction to a Novavax COVID-19 vaccine.

Your healthcare provider will determine whether any reaction you have would prevent you from safely getting the second dose.

If you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19: You may not be able to receive this vaccine until you have no symptoms and/or your required quarantine period has ended. Receiving this vaccine will not make you less contagious to other people if you are infected with COVID-19 but you have no symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you received.

Tell your vaccination provider if:

• you have a fever;

• you have any allergies;

• you have bleeding problems, or if you use a blood thinner (warfarin, Coumadin, Jantoven);

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

• you have a weak immune system caused by disease or by using certain medicine;

• you are pregnant, plan to become pregnant, or breastfeeding;

• you've received any other COVID-19 vaccine; or

• have ever fainted when or after receiving an injection.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this vaccine on the baby.

Tell your doctor if you are pregnant or breastfeeding.

How is this vaccine given?

Read all vaccine information sheets provided to you. Follow the label directions or your vaccination provider's instructions.

Novavax COVID-19 vaccine is given as an injection (shot) into a muscle in people at least 12 years old.

For people who have already received one or more doses of any COVID-19 vaccine: a single dose of Novavax COVID-19 vaccine is given 2 months after the last dose of any COVID-19 vaccine.

For unvaccinated individuals: two doses of Novavax COVID-19 vaccine are given. The second dose is given 3 weeks after the first dose.

Additional doses of the vaccine may be given if you have a weak immune system. Your doctor will determine whether you need an additional dose.

You will receive a reminder card showing the date and type of your first injection. Take this card with you if you get an additional dose.

Even after you are fully vaccinated, this vaccine will not make you less contagious if you are already infected with COVID-19 but you have no symptoms. Keep using infection control methods when you are in public or around others who may not be vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Receiving a COVID-19 vaccine will not cause you to test positive on a coronavirus test. However, once your body develops immunity to COVID-19, you could test positive on an antibody test (a test to detect immunity in your body from previous exposure to coronavirus).

It is not known how long this vaccine will protect you from infection with COVID-19. It also is not known how long immunity will last in a person who's been infected with and recovered from COVID-19. COVID-19 vaccine is still being studied and all of its risks are not yet known. Updated federal public health recommendations may be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

COVID-19 vaccine, Novavax (2023-2024) dosing information

Usual Adult Dose for COVID-19:

FOR INVESTIGATIONAL USE ONLY

Primary series: 0.5 mL IM for 2 doses, administered 3 weeks apart

First Booster Dose: 0.5 mL IM, at least 6 months after completing a primary series

Comments:
-This drug is not approved by the US FDA to prevent coronavirus disease 2019 (COVID-19). The US FDA has issued an Emergency Use Authorization (EUA) for the use of this drug to prevent COVID-19.
-No data are available regarding the use of this vaccine to complete a COVID-19 vaccine series initiated with another vaccine.

Use: For active immunization to prevent COVID-19 due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for whom other US FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in those who elect to receive this vaccine because they would otherwise not receive a COVID-19 vaccine

Usual Pediatric Dose for COVID-19:

FOR INVESTIGATIONAL USE ONLY

12 years and older:
-Primary series: 0.5 mL IM for 2 doses, administered 3 weeks apart

Comments:
-This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued an EUA for the use of this drug to prevent COVID-19.
-No data are available regarding the use of this vaccine to complete a COVID-19 vaccine series initiated with another vaccine.

Use: For active immunization to prevent COVID-19 due to SARS-CoV-2 for whom other US FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in those who elect to receive this vaccine because they would otherwise not receive a COVID-19 vaccine

What happens if I miss a dose?

Be sure to receive all recommended doses of COVID-19 vaccine or you may not be fully protected. Contact your vaccination provider or health department if you miss your dose.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid after receiving this vaccine?

Avoid receiving other vaccines without first seeking medical advice.

What other drugs will affect this vaccine?

Before receiving this vaccine, tell your vaccination provider about all other vaccines you have received. Other drugs may affect this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Before receiving this vaccine, tell your vaccination provider about all other vaccines you have received. Other drugs may affect this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.