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The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.
The EUA of this product is in duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated, or the authorization is revoked sooner.
What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
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. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of the 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 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child 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 in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Injection site reactions: pain/tenderness, swelling, redness and itching
- General side effects: fatigue or generally feeling unwell, muscle pain, headache, joint pain, nausea, vomiting, fever, chills
- Allergic reactions such as hives and swelling of the face
- Swollen lymph nodes
Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, Adjuvanted include:
- Severe allergic reactions
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Paresthesia (unusual feeling in the skin such as tingling or a crawling feeling)
- Hypoesthesia (decreased feeling or sensitivity, especially in the skin)
These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied.
What is the Novavax COVID-19 Vaccine, Adjuvanted?
The Novavax COVID-19 Vaccine, Adjuvanted is a vaccine for use in individuals 12 years of age and older to prevent COVID-19. The FDA has authorized the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted under an EUA.
The Novavax COVID-19 Vaccine, Adjuvanted may not protect everyone.
What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
Tell your vaccination provider about all of your or your child’s medical conditions, including if you or your child:
- 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
- have ever fainted in association with an injection
How is the vaccine given?
The Novavax COVID-19 Vaccine, Adjuvanted is given as an injection into the muscle.
Who should not get the Novavax COVID-19 Vaccine, Adjuvanted?
A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
- a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
- a severe allergic reaction to any ingredient of Novavax COVID-19 Vaccine, Adjuvanted
What should I do about side effects?
If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.
Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‑800‑822‑79671‑800‑822‑7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) EUA” in the first line of box #18 of the report form.
In addition, you can report side effects to Novavax, Inc., using the following contact information: Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1‑844‑NOVAVAX (1-844-668-28291-844-668-2829).
What about pregnancy or breastfeeding?
If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c‑viper.pregistry.com
Please see the Fact Sheet for Recipients and Caregivers for more information.
AUTHORIZED USE IN THE U.S.
The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.
The EUA of this product is in duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated, or the authorization is revoked sooner.
IMPORTANT SAFETY INFORMATION
What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
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. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of the 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 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child 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 in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Injection site reactions: pain/tenderness, swelling, redness and itching
- General side effects: fatigue or generally feeling unwell, muscle pain, headache, joint pain, nausea, vomiting, fever, chills
- Allergic reactions such as hives and swelling of the face
- Swollen lymph nodes
Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, Adjuvanted include:
- Severe allergic reactions
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Paresthesia (unusual feeling in the skin such as tingling or a crawling feeling)
- Hypoesthesia (decreased feeling or sensitivity, especially in the skin)
These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied.
What is the Novavax COVID-19 Vaccine, Adjuvanted?
The Novavax COVID-19 Vaccine, Adjuvanted is a vaccine for use in individuals 12 years of age and older to prevent COVID-19. The FDA has authorized the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted under an EUA.
The Novavax COVID-19 Vaccine, Adjuvanted may not protect everyone.
What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
Tell your vaccination provider about all of your or your child’s medical conditions, including if you or your child:
- 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
- have ever fainted in association with an injection
How is the vaccine given?
The Novavax COVID-19 Vaccine, Adjuvanted is given as an injection into the muscle.
Who should not get the Novavax COVID-19 Vaccine, Adjuvanted?
A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
- a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
- a severe allergic reaction to any ingredient of Novavax COVID-19 Vaccine, Adjuvanted
What should I do about side effects?
If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.
Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‑800‑822‑79671‑800‑822‑7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) EUA” in the first line of box #18 of the report form.
In addition, you can report side effects to Novavax, Inc., using the following contact information: Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1‑844‑NOVAVAX (1-844-668-28291-844-668-2829).
What about pregnancy or breastfeeding?
If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c‑viper.pregistry.com
Please see the Fact Sheet for Recipients and Caregivers for more information.
©2025 Novavax, Inc.
COM-US-COV-2300204 12/24
Emergency Use Authorization (EUA)
The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.
The EUA of this product is in duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated, or the authorization is revoked sooner.
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