Novavax COVID-19 Vaccine

Generic name: Sars-cov-2 (covid-19) NVX-CoV2601, Recombinant, Adjuvanted, 2023-2024 Formula
Brand names: Novavax
Dosage form: intramuscular injection

Usage of Novavax COVID-19 Vaccine

The Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) is authorized by the FDA under an Emergency Use Authorization (EUA) for active immunization to prevent COVID-19 in adults and children aged 12 years of age and older.

This vaccine will not treat an active COVID-19 infection. Like any vaccine, Novavax COVID-19 Vaccine, Adjuvanted 2023-2024 formula may not protect every person.

Each 0.5 mL dose of the Novavax COVID-19 Vaccine, Adjuvanted 2023-2024 formula contains 5 mcg of recombinant spike (rS) protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant comes from saponins, naturally occurring compounds in the bark of the Quillaja saponaria (Soapbark) tree, and enhances the immune response to the vaccine. The vaccine elicits an immune response to the rS protein, which protects against COVID-19.

Non-clinical data showed that Novavax's COVID-19 vaccine induced a functional immune response against XBB.1.5, XBB.1.16 and XBB.2.3 variants and neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as robust CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

The Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) is not authorized for use in children younger than 12 years of age.

Novavax COVID-19 Vaccine side effects

The Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) may cause severe side effects including allergic reactions. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. If you experience a severe allergic reaction and you are no longer at your place of vaccination, call 9-1-1, or go to the nearest hospital.

Signs of a severe allergic reaction may include:

Difficulty breathing

Swelling of your face and throat

A fast heartbeat

A bad rash all over your body

Dizziness and weakness.

Myocarditis and pericarditis

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) are rare side effects that have occurred in some people who have received COVID-19 vaccines, including Novavax. In most, symptoms began within 10 days following the vaccine, and symptoms resolved with conservative management. You should seek medical attention right away if you 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.

Common side effects

Common side effects of the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) include:

Pain or tenderness at the injection site (up to 80%)

Tiredness (up to 58%)

Muscle pain (up to 50%)

Headache (up to 47%)

Joint pain (up to 23%)

Nausea or vomiting (up to 12%)

Injection site redness (up to 7%)

Fever (up to 6%)

Injection site swelling (up to 6%).

These may not be all the possible side effects of the vaccine. 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 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Novavax COVID-19 Vaccine, Adjuvanted EUA” in the first line of box #18 of the report form.

Before taking Novavax COVID-19 Vaccine

You should not get the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) if you have:

had a severe allergic reaction after a previous dose of this vaccine

had a severe allergic reaction to any ingredient of this vaccine.

Tell your vaccination provider about all of your medical conditions, including if you:

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.

Pregnancy and breastfeeding

Available data on the use of Novavax Covid-19 vaccines during pregnancy are insufficient to inform about vaccine-associated risks during pregnancy. If you are pregnant or breastfeeding, discuss your 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/.

It is not known if the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) is excreted in human breastmilk.

How to use Novavax COVID-19 Vaccine

The Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) is given by injection in the muscle, usually the deltoid muscle of the arm.

Individuals not previously vaccinated with any COVID-19 vaccine

For adults and children 12 years of age and older NOT previously vaccinated with any COVID-19 vaccine, administer a series of two doses (0.5mL each), 3 weeks apart.

Previously Covid-19 vaccinated individuals

For adults and children 12 years of age and older previously vaccinated with any COVID-19 vaccine, administer the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) at least 2 months after the last dose of a COVID-19 vaccine. Administer as a single intramuscular dose of 0.5mL.

Warnings

Contraindicated in people who have had a severe allergic reaction (such as anaphylaxis) to any component of a Novavax COVID-19 Vaccine.

There is an increased risk of myocarditis and pericarditis occurring following the administration of Covid-19 vaccines, including Novavax.

Fainting may occur in association with vaccine administration. Tell your healthcare provider if you are prone to fainting and take measures to protect yourself from injury (such as lying down).

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have less of a response to vaccinations, including the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula).

What other drugs will affect Novavax COVID-19 Vaccine

Before receiving the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula), 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.

There is no information on the administration of the Novavax COVID-19 Vaccine, Adjuvanted at the same time as other vaccines. If you are considering receiving the Novavax COVID-19 Vaccine, Adjuvanted with other vaccines, discuss your options with your healthcare provider.

Disclaimer

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