Vaccine Information: NOVAVAX COVID-19 Vaccine, Adjuvanted (Page 2 of 9)

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

Inspect the vial

  • The Novavax COVID-19 Vaccine, Adjuvanted is a colorless to slightly yellow, clear to mildly opalescent suspension, free from visible particles.
  • Gently swirl the multi-dose vial before each dose withdrawal. Do not shake.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer the vaccine if either of these conditions exist.

Prepare for administration

  • Record the date and time of the first puncture on the vial label.
  • Novavax COVID-19 Vaccine, Adjuvanted is available as multi-dose vials containing 5 doses of 0.5 mL each.
  • Do not pool excess vaccine from multiple vials.
  • After the first needle puncture, hold the vial between 2 to 25°C (36 to 77°F).
  • Discard vial 12 hours after the first puncture.

2.2 Administration

Administer the Novavax COVID-19 Vaccine, Adjuvanted intramuscularly.

2.3 Dose and Schedule

Individuals 12 Years of Age and Older Previously Vaccinated with Any COVID-19 Vaccine

Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered intramuscularly as a single 0.5 mL dose at least 2 months after receipt of the last previous dose of COVID-19 vaccine.6

Individuals 12 Years of Age and Older Not Previously Vaccinated with Any COVID-19 Vaccine

Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered intramuscularly as a series of two doses (0.5 mL each) 3 weeks apart.

Individuals 12 Years of Age and Older with Certain Kinds of Immunocompromise

For individuals with certain kinds of immunocompromise7 , 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 (2023-2024 Formula).8 Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 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.

1 COVID-19 vaccine refers to the monovalent COVID-19 vaccines (original) and the bivalent COVID-19 vaccines (Original and Omicron BA.4/BA.5).

2 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.

3 The last dose of a COVID-19 vaccine (2023-2024 Formula) refers to a dose with Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), COMIRNATY (COVID-19 Vaccine, mRNA) (2023-2024 Formula), SPIKEVAX (COVID-19 Vaccine, mRNA) (2023-2024 Formula), Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), or Moderna COVID-19 Vaccine (2023-2024 Formula).

4 See U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020; https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency. See also U.S. Department of Health and Human Services, Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b). March 15, 2023 (“Amended Determination”); https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration.

5 See U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020); https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration. See also Amended Determination (“The declarations issued pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of certain in vitro diagnostics, personal respiratory protective devices, other medical devices and drugs and biological products, as set forth in those declarations, and that are based on the February 4, 2020 determination, remain in effect until those declarations are terminated in accordance with section 564 of the FD&C Act.”).

6 COVID-19 vaccine refers to the monovalent COVID-19 vaccines (original) and the bivalent COVID-19 vaccines (Original and Omicron BA.4/BA.5).

7 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.

8 The last dose of a COVID-19 vaccine (2023-2024 Formula) refers to a dose with Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), COMIRNATY (COVID-19 Vaccine, mRNA) (2023-2024 Formula), SPIKEVAX (COVID-19 Vaccine, mRNA) (2023-2024 Formula), Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), or Moderna COVID-19 Vaccine (2023-2024 Formula).

3 DOSAGE FORMS AND STRENGTHS

The Novavax COVID-19 Vaccine, Adjuvanted is a suspension for injection. A single dose is 0.5 mL.

4 CONTRAINDICATIONS

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Novavax COVID-19 Vaccine, Adjuvanted. [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Novavax COVID-19 Vaccine, Adjuvanted.

Monitor Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

5.2 Myocarditis and Pericarditis

Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted [see Clinical Trials Experience (6.1)].

The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#myocarditis-pericarditis).

5.3 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

5.4 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.

5.5 Limitations of Vaccine Effectiveness

The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.

6 ADVERSE REACTIONS

An overview of clinical studies contributing to the safety assessment of Novavax COVID-19 Vaccine, Adjuvanted in individuals 12 years of age and older is provided in Table 1. Participants in these clinical studies received a 2-dose initial series with a COVID-19 vaccine (referred to as a primary series) and some received one or more subsequent doses (referred to as a booster dose).

Table 1 Clinical Studies
Study Age Dosing Regimens Vaccine Recipients *
Abbreviation: SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
*
Receiving at least one dose of the intended dosing regimen.
Vaccine containing a recombinant spike protein of SARS-CoV-2 Wuhan-Hu 1 strain (Original).
Booster dose recipients are a subset of primary series.
§
Includes 39 participants who did not receive both primary series doses of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) prior to receiving a dose of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) in the booster vaccination period.
Participants received at least 3 doses of an mRNA COVID-19 vaccine prior to inclusion in this study.
#
Vaccine containing a recombinant spike protein of SARS-CoV-2 Omicron variant lineage BA.1 (Omicron BA.1), not authorized or approved in the U.S.
Þ
Vaccine containing a recombinant spike protein of SARS-CoV-2 Wuhan-Hu 1 strain (Original) and Omicron variant lineage BA.1 (Omicron BA.1), not authorized or approved in the U.S.
ß
Vaccine containing a recombinant spike protein of SARS-CoV-2 Omicron variant lineage BA.5 (Omicron BA.5), not authorized or approved in the U.S.
à
Vaccine containing a recombinant spike protein of SARS-CoV-2 Wuhan-Hu 1 strain (Original) and Omicron variant lineage BA.5 (Omicron BA.5), not authorized or approved in the U.S.
è
Restricted to participants previously vaccinated with Pfizer-BioNTech COVID-19 Vaccine.
Study 1(NCT04611802) 18 years of age and older Primary Series: 2 doses of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) 3 weeks apart 26,106
Booster Dose: Single dose of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) 12,777, §
12 years through 17 years of age Primary Series: 2 doses of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) 3 weeks apart 2,152
Booster Dose: Single dose of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) 1,499
Study 5(NCT05372588) 18 years through 64 years (Part 1) Booster Dose: Single dose of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) 274
Booster Dose: Single dose of monovalent Vaccine (Omicron BA.1)# 286
Booster Dose: Single dose of Bivalent Vaccine (Original and Omicron BA.1)Þ 269
18 years of age and older (Part 2) Booster Dose: Single dose of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) 251
Booster Dose: Single dose of monovalent Vaccine (Omicron BA.5)ß 254
Booster Dose: Single dose of Bivalent Vaccine (Original and Omicron BA.5)à 259
COV-BOOST(ISRCTN73765130) 30 years of age and older Booster Dose: Single dose of Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) 114è

The safety data accrued with the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) [no longer authorized for use in the U.S.] and from Novavax’s adjuvanted monovalent COVID-19 vaccine (Omicron BA.1) [not authorized or approved in the U.S., hereafter referred to as monovalent vaccine (Omicron BA.1)], Novavax’s adjuvanted monovalent COVID-19 vaccine (Omicron BA.5) [not authorized or approved in the U.S., hereafter referred to as monovalent vaccine (Omicron BA.5)], Novavax’s adjuvanted bivalent vaccine (Original and Omicron BA.1) [not authorized or approved in the U.S, hereafter referred to as bivalent vaccine (Original and Omicron BA.1)] and Novavax’s adjuvanted bivalent vaccine (Original and Omicron BA.5) [not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Original and Omicron BA.5)] are relevant to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) because these vaccines are manufactured using a similar process.

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