Novavax COVID-19 Vaccine

Pronunciation: No-VA-Vax
Generic name: sars-cov-2 (covid-19) NVX-CoV2601, recombinant, adjuvanted, 2023-2024 formula
Brand name: Novavax
Dosage form: intramuscular injection

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 5, 2023.

What is the Novavax COVID-19 Vaccine, Adjuvanted?

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.

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).

Related/similar drugs

Paxlovid, Lagevrio, remdesivir, molnupiravir, Actemra, nirmatrelvir / ritonavir

Before taking this medicine

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 is the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) given?

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.

What are the side effects of the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 formula) vaccine?

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.

What other drugs will affect the Novavax COVID-19 Vaccine, Adjuvanted?

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.

Storage

Unpunctured Vial

• Store between 2° to 8°C (36° to 46°F).
• Do not freeze. Protect from light.

Punctured Vial

• Store between 2° to 25°C (36° to 77°F) for up to 6 hours.
• Discard the vial 6 hours after the first puncture.

Ingredients

Active: 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 is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina.

Other ingredients: cholesterol, phosphatidylcholine, potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg) and polysorbate 80 (0.050 mg).

The pH is adjusted with sodium hydroxide or hydrochloric acid.

Each 0.5 mL dose of the Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (< 0.92 mcg), pluronic F-68 (< 2.19 mcg), Triton X-100 (< 0.025 mcg), and Tergitol (NP9) (< 0.05 mcg).

Contains no preservatives.

The vial stoppers are not made with natural rubber latex.

Manufacturer

Novavax.

Further information

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

Medical Disclaimer