COVID-19 (12y+) vaccine, Novavax (2024-2025)

Generic name: COVID-19 (12y+) vaccine, Novavax (2024-2025) [ KOE-vid-19 VAX-een ]
Brand names: Novavax COVID-19 (2024-2025) Vaccine, Adjuvanted PF (cvx 313), Novavax COVID-19 (2023-2024) Vaccine, Adjuvanted PF (cvx 313), Novavax COVID-19 (2024-2025) Vaccine, Adjuvanted PF (cvx 313)
Dosage form: intramuscular suspension (preservative-free 5 mcg/0.5 mL)
Drug class: Viral vaccines

Medically reviewed by Drugs.com on Sep 17, 2024. Written by Cerner Multum.

What is the COVID-19 vaccine?

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 COVID-19 vaccine is used to help prevent COVID-19 caused by SARS-CoV-2.

The FDA has authorized emergency use of the Novavax vaccine 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.

This vaccine side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

The vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine.

You should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive this vaccine.

Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within the first couple weeks after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

• chest pain;

• shortness of breath; or

• fast or pounding heartbeats or fluttering in your chest.

Common side effects of COVID-19 (12y+) vaccine, Novavax 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.

Related/similar drugs

Warnings

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

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;

• have any allergies;

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

• have had inflammation in or around your heart (myocarditis or pericarditis);

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

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

• have received any other COVID-19 vaccine or if you are scheduled to receive a 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.

How is this vaccine given?

Read all vaccine information sheets provided to you.

Novavax COVID-19 vaccine is given as an injection into a muscle.

Novavax COVID-19 vaccine is given to:

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

• people who have received one dose of a previous version of Novavax COVID-19 vaccine: a single dose of Novavax COVID-19 vaccine is given at least 3 weeks after the last dose.

• people who have already received a dose of any COVID-19 vaccine: a single dose of Novavax COVID-19 vaccine is given at least 2 months after the last dose of any COVID-19 vaccine.

• people who have a received two or more doses of a previous version of Novavax COVID-19 vaccine: a single dose of Novavax COVID-19 vaccine is given at least 2 months after the last dose.

The doctor or vaccination provider will determine whether an immunocompromised person needs additional doses.

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.

Keep using infection control methods when you are in public or around others who may not have been 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 (12y+) vaccine, Novavax dosing information

Usual Adult Dose for COVID-19:

FOR INVESTIGATIONAL USE ONLY

No prior history of vaccination: 0.5 mL IM as a series of 2 doses, administered 3 weeks apart
Previously vaccinated with 1 dose of any Novavax vaccine: 0.5 mL IM ONCE to complete the 2-dose series, administered at least 3 weeks after the last dose of Novavax
Previously vaccinated with any COVID-19 vaccine other than Novavax: 0.5 mL IM ONCE, administered at least 2 months after the last dose of COVID-19 vaccine

Comments:
-This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued an Emergency Use Authorization (EUA) for the use of this drug to prevent COVID-19.
-An additional dose administered at least 2 months following the last dose of this vaccine may be considered for patients who are severely immunocompromised (based on the healthcare provider's discretion).
-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)

Usual Pediatric Dose for COVID-19:

For investigational use only

12 years and older:
-No prior history of vaccination: 0.5 mL IM as a series of 2 doses, administered 3 weeks apart
-Previously vaccinated with 1 dose of any Novavax vaccine: 0.5 mL IM ONCE to complete the 2-dose series, administered at least 3 weeks after the last dose of Novavax
-Previously vaccinated with any COVID-19 vaccine other than Novavax: 0.5 mL IM ONCE, administered at least 2 months after the last dose of COVID-19 vaccine

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.
-An additional dose administered at least 2 months following the last dose of this vaccine may be considered for patients who are severely immunocompromised (based on the healthcare provider's discretion).
-No data are available regarding the use of this vaccine to complete a COVID-19 vaccine series initiated with another vaccine.

Use: For the emergency use for the active immunization to prevent SARS-CoV-2

What happens if I miss a dose?

Contact your vaccination provider or health department if you miss a 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.

Further information

• The vaccination provider, pharmacist, or doctor can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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