COVID-19 Vaccine, Adjuvanted (Novavax) (Monograph)

Drug class: Vaccines

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

Introduction

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

Uses for COVID-19 Vaccine, Adjuvanted (Novavax)

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 who have or have not previously received any COVID-19 vaccine.

The current Novavax COVID-19 vaccine, adjuvanted has been specifically formulated for the 2023-2024 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).

The current EUA authorizes use of the Novavax COVID-19 vaccine, adjuvanted 2023-2024 formula as a 2-dose series given 3 weeks apart in individuals ≥12 years of age not previously vaccinated with any COVID-19 vaccine.

The EUA also authorizes use of the Novavax COVID-19 vaccine, adjuvanted 2023-2024 formula as a single dose given at least 2 months after receipt of the last previous dose of the monovalent COVID-19 vaccine (original) or bivalent COVID-19 vaccine (Original and Omicron BA.4/BA.5) in individuals ≥12 years of age who have been previously vaccinated with any COVID-19 vaccine.

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) in individuals with certain kinds of immunocompromise.

CDC recommends an additional dose of any updated (2023-2024 formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) in adults ≥65 years of age; the additional dose should be administered at least 4 months following the previous dose of an updated COVID-19 2023–2024 vaccine.

The EUA includes certain mandatory requirements such as providing the recipient or caregiver with information consistent with the EUA fact sheet for recipients and caregivers. For additional information, consult the Novavax COVID-19 vaccine EUA letter of authorization ([Web]), EUA fact sheet for healthcare providers ([Web]), and EUA fact sheet for recipients and caregivers ([Web]).

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. The current ACIP recommendations for COVID-19 vaccinations are available at [Web].

COVID-19 Vaccine, Adjuvanted (Novavax) 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 anaphylaxis to a non-COVID-19 vaccine or injectable therapy; those with an allergy-related contraindication to a different type of COVID-19 vaccine; those with a history of a non-severe, immediate (onset within 4 hours) allergic reaction to a previous dose of COVID-19 vaccine. Vaccination providers should consider observing all other individuals for 15 minutes because of the risk of syncope.

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.

• Premedication with antihistamines prior to vaccination to prevent allergic reactions is generally not recommended; however, while antihistamines will not prevent anaphylaxis, some experts advise antihistamine use as a means of preventing milder allergic reactions in patients who might be at higher risk for allergic reactions.

Dispensing and Administration Precautions

• Appropriate medications and supplies for managing 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 multiple-dose vials with a royal blue cap.

Consult the Fact Sheet for Healthcare Providers for specific instructions on storage of the vaccine. Record the date and time of first puncture on the vial label.

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. Before each dose is withdrawn, gently swirl vial; do not shake.

Each multiple-dose vial of Novavax COVID-19 vaccine, adjuvanted (2023-2024 Formula) provides five 0.5-mL doses. A single dose of the vaccine contains 5 mcg of protein and 50 mcg of adjuvant. Do not pool excess vaccine from multiple vials.

Dosage

Pediatric Patients

Prevention of COVID-19

Individuals Not Previously Vaccinated with Any COVID-19 Vaccine

IM

Adolescents ≥12 years of age: Administer COVID-19 vaccine, adjuvanted (Novavax) (2023-2024 Formula) in 2 doses (0.5-mL each) given 3 weeks apart.

Individuals Previously Vaccinated with Any COVID-19 Vaccine

IM

Adolescents ≥12 years of age: Administer a single dose of COVID-19 vaccine, adjuvanted (Novavax) (2023-2024 Formula) ≥2 months after receipt of the last previous dose of the monovalent COVID-19 vaccine (original) or bivalent COVID-19 vaccine (Original and Omicron BA.4/BA.5).

Immunocompromised Individuals

IM

Adolescents ≥12 years of age: An additional dose of COVID-19 vaccine, adjuvanted (Novavax) (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 Formula) in individuals with certain kinds of immunocompromise. Administer additional dose at the discretion of the healthcare provider taking into consideration the individual’s clinical circumstances. Timing of the additional dose may also be based on the individual’s clinical circumstances.

Adolescents ≥12 years of age who are moderately or severely immunocompromised may receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) COVID-19 vaccine. Further additional doses may be administered based on clinical judgement. Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.

Adults

Prevention of COVID-19

Individuals Not Previously Vaccinated with Any COVID-19 Vaccine

IM

Administer COVID-19 vaccine, adjuvanted (Novavax) (2023-2024 Formula) in 2 doses (0.5-mL each) given 3 weeks apart.

Adults ≥65 years of age: Administer 1 additional dose of any updated (2023-2024 formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 4 months following the previous dose of an updated COVID-19 2023–2024 vaccine. If Novavax is used, administer 0.5 mL dose.

Individuals Previously Vaccinated with Any COVID-19 Vaccine

IM

Administer a single dose of COVID-19 vaccine, adjuvanted (Novavax) (2023-2024 Formula) ≥2 months after receipt of the last previous dose of the monovalent COVID-19 vaccine (original) or bivalent COVID-19 vaccine (Original and Omicron BA.4/BA.5).

Adults ≥65 years of age: Administer 1 additional dose of any updated (2023-2024 formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 4 months following the previous dose of an updated COVID-19 2023–2024 vaccine. If Novavax is used, administer 0.5 mL dose.

Immunocompromised Individuals

IM

An additional dose of COVID-19 vaccine, adjuvanted (Novavax) (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 Formula) in individuals with certain kinds of immunocompromise. Administer additional dose at the discretion of the healthcare provider taking into consideration the individual’s clinical circumstances. Timing of the additional dose may also be based on the individual’s clinical circumstances.

Adults up to 64 years of age who are moderately or severely immunocompromised may receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) COVID-19 vaccine. Further additional doses may be administered based on clinical judgement. Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.

Adults ≥65 years of age who are moderately or severely immunocompromised should receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) vaccine. Further additional doses may be administered based on clinical judgement. Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.

Cautions for COVID-19 Vaccine, Adjuvanted (Novavax)

Contraindications

• Known history of severe allergic reaction (e.g., anaphylaxis) to 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.

Because anaphylactic reactions have been reported rarely following administration of COVID-19 vaccines, ACIP issued interim guidance with contraindications and precautions for use.

Appropriate medications and supplies to assess and manage 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

Routine pregnancy testing is not recommended before receiving a COVID-19 vaccine.

ACOG states that vaccination against COVID-19 is recommended in women who are actively trying or are contemplating pregnancy.

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.

Decisions to administer a COVID-19 vaccine concomitantly with other vaccine(s) should be based on whether routine immunizations with the other vaccines have been delayed or missed, the individual's risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures), and reactogenicity profiles of the vaccines.

ACIP states that COVID-19 vaccines may be administered without regard to timing of other vaccines, including simultaneous administration on the same day. If a COVID-19 vaccine is administered concomitantly with other vaccines, give each parenteral vaccine at a different injection site and, if possible, separate injection sites by ≥1 inch.

Stability

Storage

Parenteral

Suspension, for IM Use

Supplied as a suspension in multiple-dose vials.

Store unopened (i.e., unpunctured) vaccine vials in the refrigerator at 2–8°C; do not freeze and protect from light.

After the first needle puncture, store vial at 2–25°C for up to 12 hours; discard the vial 12 hours after initial entry.

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) (2023-2024 Formula) contains 5 mcg of SARS-CoV-2 recombinant spike (rS) protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 and 50 mcg of Matrix-M adjuvant.

Advice to Patients

• Prior to administration of COVID-19 vaccine, adjuvanted (Novavax) (2023-2024 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) (2023-2024 Formula); advise the recipient or caregiver to read the Fact Sheet.

• Importance of the vaccination provider including vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at [Web].

• 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.

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