Introduction

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

Uses for COVID-19 Vaccine (Novavax)

Prevention of Coronavirus Disease 2019 (COVID-19)

Being investigated and used for the prevention of coronavirus disease 2019^{† [off-label]} (COVID-19) caused by SARS-CoV-2.

Although efficacy and safety not definitely established, COVID-19 (Novavax) vaccine is available under an FDA emergency use authorization (EUA) for active immunization to prevent COVID-19 in individuals ≥12 years of age.

The EUA authorizes use as a primary vaccination series^{† [off-label]} consisting of 2 doses given 3 weeks apart.

The COVID-19 (Novavax) vaccine is also authorized for emergency use to provide a first booster dose^{† [off-label]} to individuals ≥18 years of age for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals ≥18 years of age who elect to receive the Novavax COVID-19 vaccine because they would otherwise not receive a booster dose of a COVID-19 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.

Several COVID-19 vaccine types are available in the US, including a viral-vectored vaccine (Janssen COVID-19 vaccine), 2 nucleoside-modified mRNA vaccines (Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine), and a protein subunit adjuvanted vaccine (Novavax COVID-19 vaccine). The mRNA vaccines are available as monovalent vaccines (Moderna COVID-19 vaccine/Spikevax and Pfizer BioNTech COVID-19 vaccine/Comirnaty) or bivalent vaccines (Moderna COVID-19 vaccine, bivalent and Pfizer BioNTech COVID-19 vaccine, bivalent). ACIP recommends COVID-19 primary series vaccination (with one of the mRNA COVID-19 vaccines or Novavax COVID-19 vaccine) in all individuals ≥6 months of age in the US for prevention of COVID-19; individuals ≥5 years of age should also receive one bivalent mRNA booster dose after completion of any FDA-approved or FDA-authorized monovalent primary series or previously received monovalent booster dose(s). A monovalent Novavax booster dose (instead of a bivalent mRNA booster dose) may be used in limited situations in individuals ≥ 18 years of age who completed any FDA-approved or FDA-authorized monovalent primary series, have not received any previous booster dose(s), and are unable to receive an mRNA vaccine (i.e., mRNA vaccine contraindicated or not available) or unwilling to receive an mRNA vaccine and would otherwise not receive a booster dose. 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 (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.

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.

The vaccine 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 provides ten 0.5-mL doses. Do not pool excess vaccine from multiple vials.

Dosage

Pediatric Patients

Prevention of Coronavirus Disease 2019 (COVID-19)

Primary Vaccination† [off-label]

Adolescents ≥12 years of age: Administer COVID-19 vaccine (Novavax) in 2 doses (0.5-mL each) given 3 weeks apart. A single dose of the vaccine contains 5 mcg of protein and 50 mcg of adjuvant.

Adults

Prevention of Coronavirus Disease 2019 (COVID-19)

Primary Vaccination† [off-label]

Administer COVID-19 vaccine (Novavax) in 2 doses (0.5-mL each) given 3 weeks apart for a complete primary series. A single dose of the vaccine contains 5 mcg of protein and 50 mcg of adjuvant.

Booster Dose†

If a first booster dose^† using COVID-19 vaccine (Novavax) in adults is necessary, administer as a single dose (0.5 mL) at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine.

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 of COVID-19 vaccines.

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 and serious adverse events that occur following vaccination and also report all 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^† 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 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.

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.

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.

The vaccine 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 provides ten 0.5-mL doses. Do not pool excess vaccine from multiple vials.

Dosage

Pediatric Patients

Prevention of Coronavirus Disease 2019 (COVID-19)

Primary Vaccination† [off-label]

Adolescents ≥12 years of age: Administer COVID-19 vaccine (Novavax) in 2 doses (0.5-mL each) given 3 weeks apart. A single dose of the vaccine contains 5 mcg of protein and 50 mcg of adjuvant.

Adults

Prevention of Coronavirus Disease 2019 (COVID-19)

Primary Vaccination† [off-label]

Administer COVID-19 vaccine (Novavax) in 2 doses (0.5-mL each) given 3 weeks apart for a complete primary series. A single dose of the vaccine contains 5 mcg of protein and 50 mcg of adjuvant.

Booster Dose†

If a first booster dose^† using COVID-19 vaccine (Novavax) in adults is necessary, administer as a single dose (0.5 mL) at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine.

No information regarding interaction potential with COVID-19 vaccine (Novavax) and other vaccines.