COVID-19 (coronavirus 2019) vaccine, Novavax

Generic name: COVID-19 (coronavirus 2019) Vaccine, Novavax (KOE Vid (koe ROE Na Vye Rus) VAX Een)
Dosage form: intramuscular suspension (-)

Usage of COVID-19 (coronavirus 2019) vaccine, Novavax

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 US 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.

COVID-19 (coronavirus 2019) vaccine, Novavax side effects

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 the second vaccine 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.

Not all possible side effects are known. Common side effects 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.

Before taking COVID-19 (coronavirus 2019) vaccine, Novavax

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);

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

you are pregnant, plan to get pregnant, or breastfeeding; or

you've received any other COVID-19 vaccine;

have ever fainted when or after receiving an injection; or

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

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 to use COVID-19 (coronavirus 2019) vaccine, Novavax

Usual Adult Dose for COVID-19:

For investigational use onlyPrimary series: 0.5 mL IM for 2 doses, administered 3 weeks apartBooster dose: 0.5 mL IM once, at least 6 months after completing a primary series with an authorized/approved COVID-19 vaccineComments:-The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this unapproved product for active immunization to prevent coronavirus disease 2019 (COVID-19); this product is not approved by the US FDA for this use.-This vaccine is authorized to provide a 2-dose primary series.-This vaccine is authorized to provide a first booster dose to adult patients for whom a US FDA-authorized messenger RNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to adult patients who elect to receive this vaccine because they would otherwise not receive a booster dose of a COVID-19 vaccine.---Authorized bivalent COVID-19 vaccines encode the spike protein of the original severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the Omicron BA.4/BA.5 SARS-CoV-2.-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationUse: For active immunization to prevent COVID-19 caused by SARS-CoV-2

Usual Pediatric Dose for COVID-19:

For investigational use only12 years or older:-Primary series: 0.5 mL IM for 2 doses, administered 3 weeks apartComments:-The US FDA issued an EUA to allow the emergency use of this unapproved product for active immunization to prevent COVID-19; this product is not approved by the US FDA for this use.-This vaccine is authorized to provide a 2-dose primary series.-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationUse: For active immunization to prevent COVID-19 caused by SARS-CoV-2

Warnings

The US 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.

What other drugs will affect COVID-19 (coronavirus 2019) vaccine, Novavax

Before receiving this vaccine, tell your vaccination provider about all other vaccines you have received and all medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Disclaimer

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