Use for COVID-19

Novavax (NVX-CoV2373) has an emergency use authorization (EUA). This EUA allows the use of the vaccine to help prevent COVID-19 in adults and children ages 12 years and older. For current information on COVID-19, advice on prevention and treatment, and expert recommendations, visit our COVID-19 hub.

Novavax is a brand-name vaccine. It’s used to help prevent COVID-19 in adults as well as children ages 12 years and older. COVID-19 is a disease that can affect your respiratory system and other parts of your body.

To learn more about Novavax’s use in helping prevent COVID-19, see the “Novavax for COVID-19” section below.

Vaccine details

Novavax is not an mRNA vaccine like other COVID-19 vaccines. Instead, it’s a protein-based vaccine. Novavax does not contain any genetic material known as mRNA. And Novavax does not contain a live virus. (For details about vaccines that contain live viruses, see this article.)

Novavax comes as a liquid suspension in a vial. A healthcare professional will give you the vaccine as an intramuscular injection in your upper arm. You can receive Novavax at a doctor’s office, clinic, or pharmacy.

FDA authorization

In 2022, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Novavax. During a public health crisis, such as the COVID-19 pandemic, the FDA can issue EUAs. The goal is to make urgently needed supplies available quickly. These supplies can include vaccines, drugs, and tests.

Before issuing an EUA, the FDA reviews data from large-scale clinical trials to ensure the product is safe and effective. The manufacturer of Novavax is conducting ongoing clinical trials to obtain additional data about the vaccine’s safety and effectiveness. When these trials conclude, the FDA will make a decision regarding the vaccine’s full approval.

Effectiveness

For information about the effectiveness of Novavax, see the “Novavax for COVID-19” section below.

Novavax is a biologic that’s available only as a brand-name vaccine. It’s not available in a generic or biosimilar version. Novavax is considered to be a biologic because it’s partially made from living cells.*

Drugs made from chemicals can have generic versions. These contain exact copies of the active ingredient in the brand-name drug. Biologics are not made from chemicals and cannot be copied exactly. So, instead of generics, biologics have biosimilars.

* Novavax does not contain any genetic material. And Novavax does not contain a live virus. For details about vaccines that contain live viruses, see this article.

Novavax can cause mild or serious side effects. The following lists contain some of the key side effects that were seen in clinical trials of Novavax. These lists do not include all possible side effects.

For more information about the possible side effects of Novavax, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: If you would like to report a side effect you’ve had with Novavax, you can do so through the Vaccine Adverse Event Reporting System (VAERS) website or by calling 800-822-7967. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) receive reports made to VAERS.

Mild side effects

Below is a partial list of mild side effects from Novavax. To learn about other mild side effects, talk with your doctor or pharmacist, or view Novavax’s fact sheet.

Mild side effects of Novavax can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Novavax, see “Allergic reaction” below.

Serious side effects

Serious side effects from Novavax are not common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Heart problems, such as inflammation of the heart muscle and the tissue surrounding it, and cardiomyopathy (disease of the heart muscle). Symptoms can include:
    • chest pain
    • fatigue
    • swelling of legs, ankles, or feet
    • shortness of breath
  • Gallbladder problems, such as gallstones. Symptoms may include:
    • pain or cramping in your abdomen
    • bloating
    • chills or fever
    • nausea or vomiting
  • Blood clots, such as deep vein thrombosis. Symptoms of blood clots can include:
    • pain, swelling, or warmth in a leg or an arm
    • trouble breathing
    • rapid heartbeat
    • chest pain
    • feeling lightheaded
  • Fainting. Symptoms can include:
    • losing consciousness for a short time
  • Severe allergic reaction.*

* For details about allergic reaction and Novavax, see “Allergic reaction” below.

Side effects in children

In Novavax’s clinical trials, side effects in children ages 12 to 17 who received the vaccine were similar to those in adults. More common side effects in children included injection site pain or irritation. Other more common side effects included fever, headache, and fatigue.

Less commonly, some children experienced a decrease in appetite. This side effect was not seen among adults in the Novavax clinical trials.

The only serious side effect in children in Novavax clinical trials was myocarditis (inflammation of the heart muscle). This condition was rare, occurring in one child in these trials.

ALLERGIC REACTION

As with most vaccines, some people can have an allergic reaction after taking Novavax. This was a rare side effect in clinical trials of this vaccine.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Novavax, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Here are answers to some frequently asked questions about Novavax.

Is Novavax safe to receive?

Clinical trials have found that Novavax is safe for most people ages 12 years and older. However, as with other vaccines, some people have a higher risk of side effects than others.* For example, Novavax may cause an allergic reaction, especially in people who have had allergic reactions to other vaccines in the past.

In rare cases, some heart problems have occurred in people who received Novavax. These problems include myocarditis (inflammation of heart muscle) and pericarditis (inflammation of the tissue surrounding the heart muscle). So, the vaccine may pose a greater risk to people who have or have had heart problems.

For more details, see the “Novavax precautions” section below. You should also talk with your doctor to determine whether Novavax is safe for you.

* To learn more about side effects of Novavax, see the “Novavax side effects” section above.

Can Novavax be used as a booster?

Yes. A booster vaccine helps “boost” the effects of a previous vaccine that you received.

Novavax can be given as a booster if all the following criteria are met:

  • it’s been at least 6 months since you last received a COVID-19 vaccine
  • you’re not able to get a COVID-19 booster vaccine that’s approved by the Food and Drug Administration (FDA)
  • you’re age 18 years or older

If you meet all these criteria, you can receive Novavax as a booster regardless of which COVID-19 vaccines you’ve received in the past.

Your doctor and pharmacist can help answer other questions you have about Novavax and COVID-19 booster vaccines.

Does Novavax cause heart inflammation?

Possibly, but it’s rare. Heart inflammation problems called myocarditis and pericarditis have occurred in people who received Novavax.

Keep in mind that COVID-19 itself can cause heart inflammation as a serious complication. In fact, research shows that the risk of heart inflammation from a COVID-19 infection is much higher than from any COVID-19 vaccine, including Novavax.

If you’re concerned about your risk of heart inflammation, talk with your doctor before receiving Novavax. You can also see the “Novavax precautions” section below.

What is Novavax’s success rate?

In clinical trials, Novavax was effective in helping prevent mild to severe COVID-19. The vaccine began to be effective 7 days after the second dose of the vaccine or 7 days after a booster dose.*

Novavax isn’t effective right away because it takes time for your immune system to build antibodies in response to the vaccine. Antibodies are proteins that help fight infection.

You can talk with your doctor if you have additional questions about how well Novavax works to help prevent COVID-19. You can also find more details in the vaccine’s fact sheet.

* For more information, see “Can Novavax be used as a booster?” above.

The following information describes the usual Novavax dosages. These are recommended by the vaccine’s manufacturer and are authorized by the Food and Drug Administration (FDA).

Vaccine form and strength

Novavax comes as a liquid suspension in a vial. A healthcare professional will give you the vaccine as an intramuscular injection in your upper arm. You can receive Novavax at a doctor’s office, clinic, or pharmacy.

Novavax comes in one strength: 0.5 milliliters (mL).

Dosage for COVID-19

If it’s your first time getting a COVID-19 vaccine (known as a primary vaccination), you’ll receive two separate doses of Novavax. Each dose contains 0.5 mL of the vaccine. The two doses are given 3 weeks apart.

If you’re receiving Novavax as a booster, you’ll receive one dose of 0.5 mL.* The booster is given at least 6 months after your second dose of your primary vaccination.

* For more information about boosters, see the “Common questions about Novavax” section above.

Children’s dosage

Novavax is authorized for use in children ages 12 and older. The dosage for this age group is the same as the adult dosage.

Children receiving Novavax will receive two separate doses. Each dose contains 0.5 mL of the vaccine. The two doses are given 3 weeks apart.

Novavax is not currently authorized as a booster for children.* The vaccine may be given only to children ages 12 and older who are receiving a COVID-19 vaccine for the first time.

Novavax is not authorized for use in children younger than age 12 years.

* For more information about boosters, see the “Common questions about Novavax” section above.

Novavax is a vaccine that’s used to help prevent COVID-19. This is a disease that can affect your respiratory system and other parts of your body.

COVID-19 is caused by a virus called SARS-CoV-2. That’s short for severe acute respiratory syndrome coronavirus 2. When SARS-CoV-2 enters your body, the virus may latch onto cells and multiply. This can cause COVID-19 symptoms in some people. (For details, see the “Novavax for COVID-19” section below.)

What does Novavax do?

Novavax contains a small piece of a protein from the SARS-CoV-2 virus. The vaccine teaches your immune system to recognize this protein. Your immune system then makes antibodies, which are proteins that help fight infection. These antibodies will be ready to quickly fight the actual SARS-CoV-2 virus if you’re exposed to it in the future.

Novavax also contains an adjuvant. This is a substance that boosts how well your immune system reacts to a germ, such as a virus.

The Novavax vaccine does not block the virus that causes COVID-19 from entering your body. However, the vaccine can help prevent symptoms or make the disease less severe.

What kind of vaccine is Novavax?

Unlike other COVID-19 vaccines, Novavax is not an mRNA vaccine. Instead, it’s a protein-based vaccine. Novavax does not contain any genetic material known as mRNA. And Novavax does not contain a live virus. (For details about vaccines that contain live viruses, see this article.)

Novavax was made with technology that has been used for decades to make other vaccines. These include vaccines for the flu and tetanus.

If you have additional questions about Novavax or how it works, talk with your doctor or pharmacist.

How long does it take to work?

Novavax typically begins to be effective 7 days after your second dose of the vaccine or 7 days after a booster dose.* Novavax isn’t effective right away because it takes time for your immune system to build antibodies in response to the vaccine.

* For more information about boosters, see the “Common questions about Novavax” section above.

Currently, you do not have to pay to receive a COVID-19 vaccine, such as Novavax, if you live in the United States. The U.S. government (or your insurance plan, if you have one) covers the cost of the vaccine. It also covers any related administration fees from the healthcare professional who gives the vaccine. However, this could change in the future.

As with all vaccines, the cost of Novavax may also change in the future. The actual price you’ll pay could depend on your insurance plan, your location, and the pharmacy or healthcare facility you use.

Generic or biosimilar version

Novavax is a biologic that’s available only as a brand-name vaccine. It’s not available in a generic or biosimilar version. Novavax is considered to be a biologic because it’s partially made from living cells.*

Drugs made from chemicals can have generic versions. These contain exact copies of the active ingredient in the brand-name drug. Biologics are not made from chemicals and cannot be copied exactly. So, instead of generics, biologics have biosimilars.

* Novavax does not contain any genetic material. And Novavax does not contain a live virus. For details about vaccines that contain live viruses, see this article.

Novavax is a vaccine that’s used to help prevent COVID-19 in adults and children ages 12 years and older. The Food and Drug Administration (FDA) granted Novavax an emergency use authorization (EUA) for this purpose. For details, see “FDA authorization” in the “What is Novavax?” section above.

COVID-19 explained

Coronavirus disease 2019 (COVID-19) is a disease caused by a virus called SARS-CoV-2. That’s short for severe acute respiratory syndrome coronavirus 2. COVID-19 can affect your respiratory system and other parts of your body.

You can contract COVID-19 by inhaling the virus. You can also catch COVID-19 by touching a surface that the virus is on, then touching your face, eyes, nose, or mouth.

Some people may not have symptoms, so they don’t know they have COVID-19. Other people can have severe symptoms. This may lead to life threatening complications.

COVID-19 symptoms typically start within 14 days of exposure to the virus and may include:

For current recommendations on COVID-19, including its prevention and treatment, visit our COVID-19 hub.

Effectiveness for COVID-19

The results of Novavax’s clinical trials found the vaccine effective in helping prevent COVID-19. The manufacturer of Novavax is conducting ongoing clinical trials to obtain additional data about the vaccine’s safety and effectiveness. For details, see “FDA authorization” in the “What is Novavax?” section above.

Novavax and children

Novavax is used to help prevent COVID-19 in adults and children ages 12 years and older. At this time, Novavax is not authorized for use in children younger than age 12 years.

Currently, there are no known interactions between Novavax and alcohol.

If you have questions about whether it’s safe to drink alcohol before or after getting the Novavax vaccine, talk with your doctor or pharmacist.

Novavax is not known to interact with other vaccines, medications, herbs, supplements, or foods. The manufacturer of Novavax did not look at interactions in clinical trials of the vaccine.

However, this doesn’t mean that interactions won’t be recognized in ongoing or future clinical trials.* Also, new vaccines or drugs could be found to interact with Novavax.

Before receiving Novavax, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about interactions that may affect you, talk with your doctor or pharmacist.

* For details, see “FDA authorization” in the “What is Novavax?” section above.

Novavax may be given during pregnancy. COVID-19 vaccination is recommended for pregnant people.

Getting COVID-19 while pregnant can increase the risk of severe illness and pregnancy complications. This may include the child being born too early.

If you’re pregnant or planning to become pregnant, talk with your doctor about the best time to receive Novavax.

COVID-19 pregnancy registry

If you receive Novavax while pregnant, you can enroll in the COVID-19 pregnancy registry by visiting the registry website. Pregnancy registries collect information that helps determine the safety of vaccines and drugs during pregnancy.

Novavax may be given at any time during pregnancy. If you’re concerned about you or your partner becoming pregnant, talk with your doctor about your birth control needs.

For more information about taking Novavax and pregnancy, see the “Novavax and pregnancy” section above.

Experts agree that Novavax is safe to receive while breastfeeding.

If you’re breastfeeding or plan to breastfeed and have questions about the Novavax vaccine, talk with your doctor or pharmacist.

This vaccine comes with several precautions. These are considered vaccine-condition interactions.

Before taking Novavax, talk with your doctor about your health history. Novavax may not be right for you if you have certain medical conditions or other factors affecting your health. These include the ones mentioned below.

Note: For more information about the potential negative effects of Novavax, see the “Novavax side effects” section above.

Heart inflammation or other heart problems. If you developed heart inflammation after having a previous COVID-19 vaccine, talk with your doctor before receiving Novavax. You should also talk with them if you have or have had other heart problems.

Heart inflammation and other heart problems have been rarely reported in people who received Novavax. If you have heart problems, Novavax may worsen them. And if you had heart problems in the past, you may be at higher risk for them if you receive the vaccine. Be sure to talk with your doctor to find out whether Novavax is safe for you.

Immune system problems. Novavax, like other vaccines, teaches your immune system how to recognize and fight infection. If you have a weakened immune system, this vaccine may not work as well to help prevent COVID-19. You can talk with your doctor to find out whether Novavax is recommended for you.

Allergic reaction. If you’ve had an allergic reaction to Novavax, any of its ingredients, or other vaccines, your doctor will likely recommend that you do not receive Novavax. Getting the vaccine in this case may cause another allergic reaction. You can ask your doctor about other ways to help prevent COVID-19.

Pregnancy. Novavax may be given during pregnancy. For more information, see the “Novavax and pregnancy” section above.

Breastfeeding. Novavax may be given while breastfeeding. To learn more, refer to the “Novavax and breastfeeding” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.