COVID-19 Vaccine, Adjuvanted (Novavax)(2024-2025 Formula) (Monograph)

Drug class: Vaccines

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Protein subunit vaccine; contains a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant spike protein nanoparticle vaccine with Matrix-M1 adjuvant.

Uses for COVID-19 Vaccine, Adjuvanted (Novavax)(2024-2025 Formula)

Prevention of Coronavirus Disease 2019 (COVID-19)

Used for active immunization to prevent coronavirus disease 2019^{† [off-label]} (COVID-19) caused by SARS-CoV-2.

Although efficacy and safety not definitely established, available under an FDA emergency use authorization (EUA) for use in individuals ≥12 years of age.

The current Novavax COVID-19 vaccine, adjuvanted has been specifically formulated for the 2024-2025 season. Efficacy, safety, and immunogenicity of this formulation are based on data accrued with previous formulations that are no longer authorized for use in the US (Original monovalent, monovalent Omicron BA.1, monovalent Omicron BA.5, bivalent Original and Omicron BA.1, bivalent Original and Omicron BA.5, and monovalent 2023-2024 Formula).

The current EUA authorizes use of the Novavax COVID-19 vaccine, adjuvanted 2024-2025 formula as a 2-dose series given 3 weeks apart in individuals ≥12 years of age who have never been vaccinated with any COVID-19 vaccine.

The EUA also authorizes use of the Novavax COVID-19 vaccine, adjuvanted 2024-2025 formula as a single dose of the updated vaccine at least 3 weeks after the previous dose of any Novavax COVID-19 vaccine, adjuvanted to complete the 2-dose series.

The EUA also authorizes use of the Novavax COVID-19 vaccine, adjuvanted 2024-2025 formula as a single dose given at least 2 months after receipt of the last previous dose of a prior formula of a COVID-19 vaccine in individuals vaccinated with any COVID-19 vaccine, other than Novavax COVID-19 vaccine, adjuvanted, or with 2 or more doses of Novavax COVID-19 vaccine, adjuvanted.

An additional dose of Novavax COVID-19 vaccine, adjuvanted (2024-2025 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2024-2025 Formula) in individuals with certain kinds of immunocompromise.

Consult the CDC's Advisory Committee on Immunization Practices (ACIP) interim recommendations and clinical considerations for use of COVID-19 vaccines, including dosage and administration, specific populations and situations, and cautionary information.

ACIP recommends COVID-19 vaccination in all individuals ≥6 months of age in the US for prevention of COVID-19. There is currently no FDA-approved or FDA-authorized COVID-19 vaccine for children <6 months of age. CDC recommends that people receive all recommended COVID-19 vaccine doses. Vaccination is especially important for people at highest risk of severe COVID-19, including people 65 years of age and older; people with underlying medical conditions, including immune compromise; people living in long-term care facilities; and pregnant people to protect themselves and their infants. The current ACIP recommendations for COVID-19 vaccinations are available at [Web].

COVID-19 Vaccine, Adjuvanted (Novavax)(2024-2025 Formula) Dosage and Administration

General

Pretreatment Screening

• Screen all individuals for contraindications and precautions to vaccination.

Patient Monitoring

• Monitor all individuals who receive a COVID-19 vaccine for immediate adverse reactions according to CDC (ACIP) guidelines. ACIP states that vaccination providers should consider observing the following individuals for 30 minutes after receiving the vaccine: those with a history of a non-severe, immediate (onset less than 4 hours) allergic reaction to a previous dose of COVID-19 vaccine, and those with a history of a diagnosed non-severe allergy to a component of the COVID-19 vaccine. Vaccination providers should consider observing all other individuals for 15 minutes after vaccination.

Premedication and Prophylaxis

• Antipyretics or analgesics (e.g., acetaminophen, nonsteroidal anti-inflammatory agents) may be taken for the treatment of postvaccination local or systemic symptoms, if medically appropriate. However, these medications should not be used prophylactically for the purposes of prevention of post-vaccination symptoms.

Dispensing and Administration Precautions

• Appropriate medications and supplies for managing potential immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of COVID-19 vaccines.

• Syncope may occur following administration of parenteral vaccines, especially in adolescents. Patients should be seated or lying down during vaccination. Vaccination providers should consider observing vaccine recipients (especially adolescents) for 15 minutes after vaccination. If syncope develops, patients should be observed until symptoms resolve.

Administration

IM Administration

Administer by IM injection only.

Supplied as a suspension in single-dose prefilled syringes.

Should appear as a colorless to slightly yellow, clear to mildly opalescent suspension and should not contain any visible particles. Do not use if particulate matter or discoloration is observed.

Each dose of Novavax COVID-19 vaccine, adjuvanted (2024-2025 Formula) contains 5 mcg of protein and 50 mcg of adjuvant.

Dosage

The recommended number of doses of COVID-19 vaccine, adjuvanted (Novavax) (2024-2025 Formula) and interval between doses are based on age and vaccination history as follows in the dosage sections below.

Pediatric Patients

Prevention of COVID-19

Adolescents ≥12 years of age Who are Not Immunocompromised

IM

Unvaccinated: Administer a series of 2 doses (0.5-mL each); dose 2 should be administered 3–8 weeks after dose 1.

Previously vaccinated with 1 or more doses of any mRNA COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.

Previously vaccinated with 1 dose of any Novavax COVID-19 vaccine: Administer a single 0.5 mL dose 3–8 weeks after dose 1.

Previously vaccinated with 2 or more doses of any Novavax COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.

Immunocompromised Adolescents ≥12 years of age

IM

Unvaccinated: Administer a 2-dose series (0.5 mL each); dose 2 should be administered 3 weeks after dose 1.

Previously vaccinated with 3 or more doses of an mRNA COVID-19 vaccine NOT including at least 1 dose of any 2024-2025 COVID-19 vaccine: administer a single dose of 0.5 mL at least 8 weeks after the last dose.

Previously vaccinated with 1 dose of any Novavax COVID-19 vaccine: administer a single 0.5 mL dose 3 weeks after dose 1.

Previously vaccinated with 2 or more doses of any Novavax NOT including 1 dose of any 2024-2025 COVID-19 vaccine: administer a single 0.5 mL dose at least 8 weeks after the last dose.

One or more additional doses may be administered based on clinician discretion.

Adults

Prevention of COVID-19

Adults Who are Not Immunocompromised

IM

Unvaccinated: Administer a series of 2 doses (0.5-mL each); dose 2 should be administered 3–8 weeks after dose 1.

Previously vaccinated with 1 or more doses of any mRNA COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.

Previously vaccinated with 1 dose of any Novavax COVID-19 vaccine: Administer a single 0.5 mL dose 3–8 weeks after dose 1.

Previously vaccinated with 2 or more doses of any Novavax COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.

Immunocompromised Adults

IM

Unvaccinated:Administer a 2-dose series (0.5 mL each); dose 2 should be administered 3 weeks after dose 1 .

Previously vaccinated with 3 or more doses of an mRNA COVID-19 vaccine NOT including at least 1 dose of any 2024-2025 COVID-19 vaccine: administer a single dose of 0.5 mL at least 8 weeks after the last dose.

Previously vaccinated with 1 dose of any Novavax COVID-19 vaccine: administer a single 0.5 mL dose 3 weeks after dose 1.

Previously vaccinated with 2 or more doses of any Novavax NOT including 1 dose of any 2024-2025 COVID-19 vaccine: administer a single 0.5 mL dose at least 8 weeks after the last dose.

One or more additional doses may be administered based on clinician discretion.

Cautions for COVID-19 Vaccine, Adjuvanted (Novavax)(2024-2025 Formula)

Contraindications

• Known history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of Novavax COVID-19 vaccine, adjuvanted or any component of the vaccine.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., urticaria, hypersensitivity, angioedema, facial swelling) reported following administration of the Novavax COVID-19 vaccine; one serious case (generalized urticaria and facial angioedema) occurred.

Appropriate medications and supplies to assess and manage potential immediate allergic reactions (e.g., sufficient quantities of epinephrine in prefilled syringes or autoinjectors) must be immediately available during administration of a COVID-19 vaccine.

Monitor vaccine recipients for immediate adverse reactions according to CDC guidelines ([Web]).

Myocarditis and Pericarditis

Myocarditis and pericarditis reported following administration of the Novavax COVID-19 vaccine. Occurred in temporal relationship to vaccine administration raising concern for a causal relationship.

Over the course of the clinical development program, 6 cases of myocarditis and pericarditis occurred after administration of the vaccine and 1 case occurred after administration of placebo.

Syncope

Syncope may occur following administration of parenteral vaccines. Take appropriate measures to decrease the risk of injury if the vaccine recipient becomes dizzy or loses consciousness. If syncope occurs, observe the patient until symptoms resolve.

Altered Immunocompetence

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

Limitations of Vaccine Effectiveness

The Novavax COVID-19 vaccine may not protect all vaccine recipients against COVID-19.

EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting

Vaccine providers must report all vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome (MIS), and COVID-19 cases that result in hospitalization or death following vaccination to the Vaccine Adverse Event Reporting System (VAERS).

Specific Populations

Pregnancy

Data are insufficient regarding use of COVID-19 vaccine (Novavax) in pregnant women. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development observed in animal studies.

A pregnancy registry has been established. Encourage women who are vaccinated with the Novavax COVID-19 vaccine during pregnancy to enroll in the registry by visiting [Web].

ACIP and the American College of Obstetricians and Gynecologists (ACOG) recommend vaccination against COVID-19 in pregnant women.

Females and Males of Reproductive Potential

ACOG recommends COVID-19 vaccination in people who are pregnant, trying to get pregnant, or might become pregnant in the future.

Lactation

Data are not available to assess whether COVID-19 vaccine (Novavax) has any effects on a breast-fed infant or on milk production.

ACIP and ACOG recommend COVID-19 vaccination in all lactating people.

Pediatric Use

The COVID-19 vaccine (Novavax) is not authorized for use in individuals <12 years of age.

The FDA EUA permits use of the COVID-19 vaccine (Novavax) for prevention of COVID-19 in adolescents 12 through 17 years of age^{† [off-label]} based on safety and effectiveness data in this age group in addition to data from the adult population.

Geriatric Use

Individuals ≥65 years of age were included in clinical trials evaluating COVID-19 vaccine (Novavax), and data from such individuals contribute to overall assessment of safety and efficacy of the vaccine.

At the time of FDA's safety analysis of data for the EUA, 12.6% of participants were ≥65 years of age and 1.8% were ≥75 years of age. Vaccine efficacy in participants ≥65 years of age was 78.6% compared with 90.7% in participants 50–64 years of age. There was no overall difference in safety between those ≥65 years of age and younger individuals.

Common Adverse Effects

Safety of the Novavax COVID-19 vaccine was assessed in several clinical studies.

Local and systemic events were more common with the vaccine compared with placebo; such events increased in frequency and severity following the second dose. The most frequently reported solicited local adverse reaction was injection site pain/tenderness. Fatigue/malaise, headache, and muscle pain (myalgia) were most commonly reported solicited systemic effects.

Other adverse events that were reported infrequently but more often with vaccine versus placebo included acute cholecystitis, neurovascular events, cardiac failure, cardiomyopathy, and uveitis.

Drug Interactions

Vaccines

No data to assess safety and immunogenicity of concomitant administration of COVID-19 vaccine (Novavax) with other vaccines. However, ACIP states that COVID-19, influenza, and respiratory syncytial virus (RSV) vaccines may be simultaneously administered to eligible patients.

Simultaneous administration of COVID-19 vaccine and nirsevimab is recommended. There are additional considerations for simultaneous administration of an orthopoxvirus vaccine and COVID-19 vaccine. See ACIP recommendations for additional information.

Stability

Storage

Parenteral

Suspension, for IM Use

Store single-dose prefilled syringes in the refrigerator at 2–8°C; do not freeze and protect from light.

Actions

• Protein subunit vaccine; contains a SARS-CoV-2 recombinant spike (rS) protein nanoparticle vaccine with Matrix-M1 adjuvant.

• Used to stimulate active immunity to SARS-CoV-2.

• The rS protein is produced by recombinant DNA technology using a baculovirus expression system in an insect cell line.

• The Matrix-M adjuvant is composed of saponin extracts from the soapbark tree, Quillaja saponaria Molina.

• Each dose (0.5 mL) of the COVID-19 vaccine, adjuvanted (Novavax) (2024-2025 Formula) contains 5 mcg of SARS-CoV-2 recombinant spike (rS) protein from the SARS-CoV-2 Omicron variant lineage JN.1 and 50 mcg of Matrix-M adjuvant.

Advice to Patients

• Prior to administration of COVID-19 vaccine, adjuvanted (Novavax) (2024-2025 Formula), provide the vaccine recipient or their caregiver with information consistent with the Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) (2024-2025 Formula); advise the recipient or caregiver to read the Fact Sheet.

• Importance of vaccine recipients informing their vaccination provider if they previously received any other COVID-19 vaccine, have any medical conditions (e.g., bleeding disorders, immunocompromising diseases), or are receiving anticoagulants or immunosuppressive therapy.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 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 vaccine during pregnancy are encouraged to enroll in the registry by visiting [Web]/.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Reload page with references included

Medical Disclaimer