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

Brand name: Nuvaxovid(2024-2025 Formula)
Drug class: Vaccines

Medically reviewed by Drugs.com on Aug 10, 2025. 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-M 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 19 (COVID-19) caused by SARS-CoV-2.

The vaccine labeled as Nuvaxovid is FDA-approved for prevention of COVID-19 in adults ≥65 years of age and in patients 12—64 years of age who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Previous preparations were available for use under an Emergency Use Authorization (EUA); however, FDA approved a biologics license application (BLA) for COVID-19 vaccine, adjuvanted on May 16, 2025.

The current Novavax COVID-19 vaccine, adjuvanted has been specifically formulated for the 2024-2025 season.

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.

Verify label on pre-filled syringe states 2024-2025 Formula prior to administration.

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 in the dosage sections below.

Minimum interval between first and second doses recommended for patients who are moderately or severely immunocompromised, ≥65 years of age, or in situations where fullest possible protection needs to be achieved sooner (e.g., increased concern about higher risk for severe disease).

Pediatric Patients

Prevention of COVID-19

Adolescents ≥12 years of Age at High Risk for Severe Outcomes Who Are Not Immunocompromised

Unvaccinated: Administer a series of 2 doses (0.5-mL each); dose 2 should be administered 3–8 weeks after dose 1. CDC states that an 8-week interval between first and second doses might be optimal for some as it might reduce rare risk of myocarditis and pericarditis.

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. CDC states that an 8-week interval between first and second doses might be optimal for some as it might reduce rare risk of myocarditis and pericarditis.

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 at High Risk for Severe Outcomes

Unvaccinated: Administer a 3-dose series (0.5 mL each); dose 2 should be administered 3 weeks after dose 1 and dose 3 should be administered 6 months (minimum interval 2 months) after dose 2.

Previously vaccinated with 1 dose of an mRNA COVID-19 vaccine NOT including at least 1 dose of any 2024-2025 COVID-19 vaccine: Administer a series of 2 doses of an mRNA COVID-19 vaccine (same manufacturer as the previously administered dose) based on ACIP schedule, followed by a single 0.5 mL dose (dose 3) of COVID-19 vaccine, adjuvanted (Novavax) at least 6 months (minimum interval 2 months) after completion of the last dose (dose 2) of the mRNA COVID-19 vaccine series.

Previously vaccinated with 2 doses of an mRNA COVID-19 vaccine NOT including at least 1 dose of any 2024-2025 COVID-19 vaccine:Administer dose 1 of an mRNA COVID-19 vaccine (same manufacturer as the previously administered doses) at least 4 weeks after the last dose, followed by a single 0.5 mL dose (dose 2) of COVID-19 vaccine, adjuvanted (Novavax) at least 6 months (minimum interval 2 months) after completion of the last dose (dose 1) of the mRNA COVID-19 vaccine series.

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 2-dose series (0.5 mL each); dose 1 should be administered at least 8 weeks after the last dose and dose 2 should be administered 6 months (minimum interval 2 months) after dose 1.

Previously vaccinated with 1 dose of any Novavax COVID-19 vaccine: Administer a 2-dose series (0.5 mL each); dose 1 should be administered at least 3 weeks after the last dose and dose 2 should be administered 6 months (minimum interval 2 months) after dose 1. CDC states that an 8-week interval between first and second doses might be optimal for some as it might reduce rare risk of myocarditis and pericarditis.

Previously vaccinated with 2 or more doses of any Novavax NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a 2-dose series (0.5 mL each); dose 1 should be administered at least 8 weeks after the last dose and dose 2 should be administered 6 months (minimum interval 2 months) after dose 1.

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

Adults

Prevention of COVID-19

Adults ≥65 Years of Age Who Are Not Immunocompromised

Unvaccinated: Administer a series of 3 doses (0.5-mL each); dose 2 should be administered 3–8 weeks after dose 1 and dose 3 should be administered 6 months (minimum interval 2 months) after dose 2. CDC states that an 8-week interval between first and second doses might be optimal for some as it might reduce rare risk of myocarditis and pericarditis. In unvaccinated patients who receive dose 1 of a 2024-2025 vaccine mRNA COVID-19 vaccine, CDC recommends a total series of 2 doses, with dose 2 (0.5 mL) of COVID-19 vaccine, adjuvanted (Novavax) being administered 6 months (minimum interval 2 months) after dose 1 of the mRNA COVID-19 vaccine.

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 2 dose series (0.5 mL each); dose 1 should be administered at least 8 weeks after the last dose and dose 2 should be administered 6 months (minimum interval 2 months) after dose 1.

Previously vaccinated with 1 dose of any Novavax COVID-19 vaccine: Administer a series of 2 doses (0.5 mL each); dose 1 should be administered 3–8 weeks after the last dose and dose 2 should be administered 6 months (minimum interval 2 months) after dose 1. CDC states that an 8-week interval between the first and second doses might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis.

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 2-dose series (0.5 mL each); dose 1 should be administered at least 8 weeks after the last dose and dose 2 should be administered 6 months (minimum interval 2 months) after dose 1.

Adults 18—64 Years of Age at High Risk for Severe Outcomes Who Are Not Immunocompromised

Administer a series of 2 doses (0.5-mL each); dose 2 should be administered 3–8 weeks after dose 1. CDC states that an 8-week interval between first and second doses might be optimal for some as it might reduce rare risk of myocarditis and pericarditis.

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.

Immunocompromised Adults

Unvaccinated: Administer a 3-dose series (0.5 mL each); dose 2 should be administered 3 weeks after dose 1 and dose 3 should be administered 6 months (minimum interval 2 months) after dose 2.

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, adjuvanted; 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, adjuvanted. 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 2 cases occurred after administration of placebo (one of which received Novavax COVID-19 vaccine, adjuvanted 504 days prior to event).

CDC has published considerations related to myocarditis and pericarditis after vaccination, including vaccination of individuals with history of myocarditis or pericarditis ([Web]).

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.

Although some individuals with altered immunocompetence (e.g., HIV infection) were included in clinical trials, the number of such individuals has been insufficient to evaluate safety of the vaccine.

Limitations of Vaccine Effectiveness

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

Specific Populations

Pregnancy

Data are insufficient regarding use of COVID-19 vaccine, adjuvanted (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.

Lactation

Data are not available to assess whether COVID-19 vaccine, adjuvanted (Novavax) has any effects on a breast-fed infant or on milk production. Not known if distributed into human milk.

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

Females and Males of Reproductive Potential

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

Not evaluated for potential to cause impairment of male fertility.

Pediatric Use

Safety and efficacy established in adolescents 12—17 years of age with at least one high risk factor for severe COVID-19 outcomes based on safety and effectiveness in this age group and in adults. Safety and efficacy have not been established in patients <12 years of age. COVID-19 vaccine, adjuvanted (Novavax) is not authorized for use in individuals <12 years of age.

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.

In a phase 3 clinical trial, 12.6% of participants were ≥65 years of age and 1.8% were ≥75 years of age. No overall difference in safety observed between those ≥65 years of age and younger individuals.

Common Adverse Effects

Clinical trial participants 12—17 years of age (>10%): injection site tenderness, injection site pain, headache, fatigue, muscle pain, malaise, nausea/vomiting, fever, joint pain.

Clinical trial participants 18—64 years of age (>10%): injection site tenderness, injection site pain, muscle pain, fatigue, headache, malaise, joint pain, nausea/vomiting.

Clinical trial participants ≥65 years of age (>10%): injection site tenderness, injection site pain, fatigue, muscle pain, headache, malaise, joint pain.

Booster dose in participants 12—17 years of age (>10%): injection site tenderness, injection site pain, headache, muscle pain, fatigue, malaise, nausea/vomiting, joint pain, fever, injection site redness.

Booster dose in participants ≥18 years of age (>10%): injection site tenderness, injection site pain, muscle pain, fatigue, headache, malaise, joint pain, nausea/vomiting.

Drug Interactions

Vaccines

Minimal 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 in the original carton protected from light; do not freeze.

Actions

Protein subunit vaccine; contains a SARS-CoV-2 recombinant spike (rS) protein nanoparticle vaccine with Matrix-M 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 derived from the Spodoptera frugiperdaspecies.
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

Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling.
Inform the vaccine recipient or caregiver of the potential benefits and risks of vaccination with COVID-19 vaccine, adjuvanted (Novavax).
Instruct the vaccine recipient or caregiver to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 or [Web].
Inform patients of the importance of 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]/.
Advise vaccine recipients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.
Advise vaccine recipients of other precautionary information.

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.

COVID-19 Vaccine, Adjuvanted (Novavax)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Suspension, for IM use	5 mcg of SARS-CoV-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant per 0.5-mL dose	Nuvaxovid (2024-2025 Formula)	Novavax