Novavax vaccine
Pronunciation: No-VA-vax
Generic name: sars-cov-2 (covid-19) nvx-cov2705 vaccine, adjuvanted
Brand names: Novavax COVID-19 (2024-2025) Vaccine, Adjuvanted
Dosage form: Intramuscular injection
What is the Novavax COVID-19 Vaccine?
The Novavax COVID-19 vaccine is a protein subunit vaccine that may be used to help develop immunity to SARS-CoV-2, the virus that causes COVID-19 in adults and children 12 years of age and older.
- Novavax has been updated for 2024-2025 to cover Omicron JN.1.
- Novavax is available for use under the FDA's Emergency Use Authorization (EUA).
- It is not authorized for use in children younger than 12 years of age.
- Novavax will not treat an active COVID-19 infection.
Novavax does not contain live virus particles, including those of SARS-CoV-2, the virus that causes COVID-19. It cannot give you COVID-19, although it may not protect everyone who receives the vaccine.
The Novavax COVID-19 vaccine has a mechanism of action that is different from mRNA vaccines like Pfizer's Comirnaty and Moderna's Spikevax. Novavax is a protein subunit vaccine and is based on a more traditional vaccination approach than mRNA vaccines. It contains a lab-made version of the SARS-CoV-2 spike protein which mimics the molecular structure of the virus but cannot replicate or cause COVID-19. Novavax vaccine includes an adjuvant (a substance that enhances immune response) derived from tree bark. When injected, these components stimulate the immune system to produce antibodies and T-cells against the spike protein so that when the vaccinated person later encounters the real virus, their immune system is primed to recognize and fight it off.
Novavax does not have FDA approval and is only available under an EUA. Novavax first gained EUA status on July 13, 2022.
- Under the EUA, there is an option to accept or refuse to receive this vaccine. If you decide not to
receive this vaccine or for your child not to receive this vaccine, it will not change the standard
medical care.
Novavax vaccine side effects
The most common side effects of the Novavax vaccine are:
- Pain, tenderness, redness, or swelling at the injection site
- Tiredness
- Muscle pain
- Headache
- Joint pain
- Nausea or vomiting
- Injection site redness
- Fever
- Injection site swelling.
Other side effects reported include:
- Swollen lymph nodes
Paresthesia (unusual feeling in the skin such as tingling or a crawling feeling) - Hypoesthesia (decreased feeling or sensitivity, especially in the skin)
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 may have less of a response to vaccinations, including the Novavax vaccine.
Serious side effects and warnings
Novavax may cause the following serious side effects.
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 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.
Allergic reactions. Novavax, like other vaccines, may cause an allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Novavax 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.
These may not be all the possible side effects of the Novavax vaccine. Serious and unexpected side effects may occur. The possible side effects are still being studied.
- 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 description section of the report.
Before taking
You or your child should not get a Novavax vaccine 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
There is limited data about the use of Novavax in pregnant women and not enough information to determine risks during pregnancy. If you are pregnant or breastfeeding, discuss your vaccination options with your healthcare provider. Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19
compared with non-pregnant individuals.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who have been given the Novavax vaccine during pregnancy and women are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com/.
Breastfeeding
It is not known if the Novavax vaccine is excreted in human breast milk.
How is the Novavax vaccine given?
Novavax is given by an intramuscular injection, usually into the deltoid muscle of the upper arm.
- Tell your healthcare provider if you are prone to fainting and take measures to protect yourself from injury (such as lying down).
- Your vaccination provider may ask you to stay a few minutes at the place where you received your vaccine for monitoring after vaccination, in case of an allergic reaction.
Novavax vaccine dosage
Adults and children 12 and older not previously vaccinated with any COVID-19 vaccine
- Administer 2 doses of the Novavax vaccine.
- First dose: Novavax 0.5 mL
- Second dose (3 weeks later): Novavax 0.5 mL.
Adults and children 12 and older previously vaccinated with 1 dose of Novavax
- Administer 1 dose of the Novavax vaccine at least 3 weeks after the previous dose.
- Single dose: Novavax 0.5 mL
Adults and children 12 and older previously vaccinated with any COVID vaccine or 2 previous doses of Novavax
- Administer 1 dose of the Novavax vaccine at least 2 months after the previous dose.
- Single dose: Novavax 0.5 mL
Immunocompromised individuals 12 years of age and older
- May receive additional doses of the Novavax vaccine.
What other drugs affect the Novavax vaccine?
Before receiving Novavax, tell your vaccination provider about all the 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 vaccine at the same time as other vaccines.
- Talk to your healthcare provider about this if you wish to receive other vaccines at the same time as Novavax.
Ingredients
The Novavax vaccine is available in single-dose pre-filled syringes.
Active: Novavax contains a recombinant form of the SARS-CoV-2 spike protein produced from baculovirus infected Sf9 (fall armyworm) insect cells. The adjuvant is Matrix-MTM which contains saponins derived from the soapbark tree (Quillaja saponaria Molina).
Other ingredients: cholesterol, phosphatidylcholine, potassium dihydrogen phosphate, potassium chloride disodium hydrogen phosphate dihydrate, sodium chloride, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, and polysorbate 80.
The vaccine may also contain small amounts of baculovirus and insect cell proteins and DNA.
Who makes Novavax vaccine?
Novavax makes Novavax vaccine
References
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.