What you need to know about the Novavax
COVID‑19 Vaccine, Adjuvanted (2024-2025 Formula)

For representation purposes only. Actual size, packaging, and appearance may differ.

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Ingredients

The Novavax COVID-19 vaccine is a colorless-to-slightly yellow, clear-to-mildly opalescent suspension for intramuscular injection that is free from visible particles. Each 0.5 mL dose of the Novavax COVID-19 vaccine contains 5 mcg of recombinant spike (rS) protein from the SARS-CoV-2 Omicron variant lineage JN.1 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.1

The rS protein is produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.1

Each 0.5 mL dose of the Novavax COVID‑19 vaccine also contains the following 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.1

Each 0.5 mL dose of the Novavax COVID‑19 vaccine 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).1

The Novavax COVID‑19 vaccine does not contain a preservative.1

Adverse reactions

In a clinical trial, among participants 18 through 64 years of age (n=15,884), solicited adverse reactions (ARs) of any grade following administration of the first dose of the Novavax COVID-19 vaccine were injection site pain/tenderness (60.5%), fatigue/malaise (30.8%), headache (26.2%), muscle pain (24.1%), joint pain (7.9%), nausea or vomiting (6.7%), injection site redness (1.0%), injection site swelling (0.9%), and fever (0.4%). Solicited ARs following administration of the second dose (n=15,148) were injection site pain/tenderness (80.8%), fatigue/malaise (58.3%), headache (47.1%), muscle pain (50.7%), joint pain (23.4%), nausea or vomiting (12.0%), injection site redness (6.9%), injection site swelling (6.2%), and fever (6.2%).1

In participants ≥65 years of age (n=2,251), solicited ARs following administration of the first dose of the Novavax COVID-19 vaccine were injection site pain/tenderness (37.9%), fatigue/malaise (19.7%), muscle pain (12.6%), headache (15.3%), joint pain (6.2%), nausea or vomiting (3.6%), injection site swelling (0.8%), injection site redness (0.7%), and fever (0.4%). Solicited ARs following administration of the second dose (n=2,048) were injection site pain/tenderness (61.4%), fatigue/malaise (34.9%), muscle pain (27.4%), headache (24.5%), joint pain (13.2%), nausea or vomiting (5.3%), injection site swelling (5.4%), injection site redness (4.8%), and fever (2.0%).1

In a clinical trial, among participants 12 through 17 years of age (n=1,448), solicited ARs following administration of the first dose of the Novavax COVID-19 vaccine were injection site pain/tenderness (65.3%), muscle pain (34.0%), headache (30.4%), fatigue/malaise (28.9%), nausea or vomiting (7.8%), joint pain (7.0%), injection site swelling (1.4%), injection site redness (1.0%), and fever (0.8%). Solicited ARs following administration of the second dose (n=1,394) were injection site pain/tenderness (75.0%), muscle pain (49.0%), headache (56.9%), fatigue/malaise (57.9%), nausea or vomiting (19.9%), joint pain (16.2%), injection site swelling (8.0%), injection site redness (7.5%), and fever (16.9%).1

In a clinical trial, among participants 18 years of age and older (N=238), solicited ARs following administration of a booster dose were injection site pain/tenderness (81.1%), fatigue/malaise (63.4%), muscle pain (63.0%), headache (52.9%), joint pain (30.3%), nausea or vomiting (14.7%), injection site swelling (8.4%), injection site redness (6.3%), and fever (6.3%).1

In a clinical trial, among participants 12 through 17 years of age (N=190), solicited ARs following administration of a booster dose were injection site pain/tenderness (80.5%), fatigue/malaise (69.5%), headache (68.4%), muscle pain (61.6%), nausea or vomiting (26.3%), fever (23.2%), joint pain (22.6%), injection site redness (10.5%), and injection site swelling (10.0%).1

No. The Novavax COVID‑19 vaccine does not contain SARS-CoV-2. The Novavax COVID‑19 vaccine contains purified, full-length rS protein. The vaccine elicits an immune response to the rS protein, which helps protect against COVID‑19.1

Use in specific populations

Available data on the Novavax COVID‑19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.1

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID‑19 vaccine during pregnancy. Women who are vaccinated with the Novavax COVID‑19 vaccine during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com/.1

Data are not available to assess the effects of the Novavax COVID‑19 vaccine on breastfed infants or on milk production/excretion.1

For individuals with certain kinds of immunocompromise, an additional dose of Novavax COVID-19 vaccine may be administered at least 2 months following the last dose of a COVID-19 vaccine. Additional doses of Novavax COVID-19 vaccine may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances. Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.1

See Fact Sheet for Healthcare Providers for dosing information for these patients.

The Novavax COVID-19 vaccine is authorized for use in individuals 12 years of age and older and is not authorized for use in individuals younger than 12 years of age.1

Clinical studies that evaluated primary vaccination with the Novavax COVID-19 vaccine included participants 65 years of age and older receiving vaccine or placebo, and their data contribute to the overall assessment of safety and efficacy. In an ongoing phase 3 clinical study, 12.6% (n=2,480 Novavax COVID‑19 vaccine, n=1,235 placebo) of participants were 65 years of age and older and 1.8% (n=361 Novavax COVID‑19 vaccine, n=179 placebo) of participants were 75 years of age and older. Vaccine efficacy in participants 65 years of age and older was 78.6% (95% CI: -16.6, 96.1) relative to 90.7% (95% CI: 72.9, 96.8) in participants 50 through 64 years of age.1

Overall, there were no notable differences in the safety profiles observed between participants 65 years of age and older and younger participants.1

Supply and distribution

The Novavax COVID‑19 vaccine is supplied as1:

  • Carton (NDC 80631-107-10) containing 10 single-dose prefilled syringes. Each prefilled syringe (NDC 80631-107-01) contains 1 dose of 0.5 mL.

Storage and handling

Novavax COVID-19 vaccine prefilled syringes should be stored in the refrigerator at 2 to 8 °C (36 to 46 °F).1

Do not freeze.1

Protect from light.1

Yes, the vaccine should be protected from light.1

To find the expiration date for any prefilled syringe, please identify the Lot number from the packaging and refer to the expiry information here.

The Novavax COVID‑19 vaccine should not be frozen.1

Dosage and administration

Never vaccinated with any COVID-19 vaccine
  • The Novavax COVID-19 vaccine is administered intramuscularly as a series of two doses (0.5 mL each), 3 weeks apart1
Vaccinated only with 1 dose of any Novavax COVID-19 vaccine
  • The Novavax COVID-19 vaccine is administered intramuscularly as a single 0.5 mL dose at least 3 weeks after the previous dose to complete the 2-dose series1
Vaccinated with any COVID-19 vaccine, other than the Novavax COVID-19 vaccine, or with 2 or more doses of the Novavax COVID-19 vaccine
  • The Novavax COVID-19 vaccine is administered intramuscularly as a single 0.5 mL dose at least 2 months after receipt of the last previous dose of a COVID-19 vaccine1*
Individuals with certain kinds of immunocompromise†
  • An additional dose of the Novavax COVID-19 vaccine may be administered at least 2 months following the last dose of a COVID-19 vaccine1
  • Additional doses of the Novavax COVID-19 vaccine may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances1
  • The timing of the additional doses may be based on the individual’s clinical circumstances1

*The last previous dose of COVID-19 vaccine refers to a prior dose with a COVID-19 vaccine other than a COVID-19 vaccine (2024-2025 Formula).

†Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent
level of immunocompromise.1

According to the CDC, COVID-19 vaccines can be coadministered with flu and RSV vaccines to eligible patients.2

References: 1. Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) EUA Fact Sheet for Healthcare Providers. Novavax Inc.; August 2024. 2. Centers for Disease Control and Prevention. Getting a flu vaccine and other recommended vaccines at the same time. https://www.cdc.gov/flu/prevent/coadministration.htm. Updated December 8, 2023. Accessed June 17, 2024.