What you need to know about the Novavax
COVID‑19 Vaccine, Adjuvanted (2023-2024 Formula)

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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 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.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 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 vial stoppers are not made with natural rubber latex.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) 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=2,241), 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 protects 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, Adjuvanted (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine. Additional doses of Novavax COVID-19 Vaccine, Adjuvanted 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 through 17 years of age and is not authorized for use in individuals younger than 12 years of age.1

Clinical studies of the Novavax COVID‑19 vaccine included participants 65 years of age and older receiving vaccine or placebo, and their data contributed 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

Please note that in the spring of 2024 ACIP added a new COVID-19 vaccination recommendation stating persons 65+ should receive an additional dose of 2023-2024 COVID-19 vaccine at least 4 months after their last dose of the 2023-2024 COVID-19 vaccine.2

Supply and distribution

The Novavax COVID‑19 vaccine is supplied as1:

  • Carton (NDC 80631-105-02) containing 2 multidose vials (NDC 80631-105-01). Each multidose vial contains 5 doses of 0.5 mL each

Storage and handling

Store unpunctured multidose vials of the Novavax COVID‑19 vaccine refrigerated at 2 to 8 °C (36 to 46 °F).1

Do not freeze.1

Protect from light.1

After the first needle puncture, store the vial between 2 and 25 °C (36 and 77 °F) for up to 12 hours. Discard the vial 12 hours after first puncture.1

Yes, the vaccine should be protected from light.1

Shipped packages and vials do not include expiration dates. Each carton and each vial includes a QR code. Scanning the QR code with a smartphone will bring you to an online resource that allows you to find the expiration date for any vial, based on its lot number. The lot number is printed on the packaging.1

You can look up the lot number expiration here: https://us.novavaxcovidvaccine.com/hcp.

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

Dosage and administration

Previously vaccinated with any 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 vaccine
Not previously 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 apart
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 vaccine
  • 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 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.

References: 1. Novavax COVID‑19 Vaccine, Adjuvanted (2023-2024 Formula) EUA Fact Sheet for Healthcare Providers. Novavax, Inc.; October 2023. 2. Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines in the United States. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html. Updated February 28, 2024. Accessed March 1, 2024.