Zoster Vaccine Recombinant

Brand name: Shingrix
Drug class: Vaccines
VA class: IM100

Medically reviewed by Drugs.com on Nov 16, 2022. Written by ASHP.

Introduction

Inactivated (recombinant) vaccine. Zoster vaccine recombinant contains recombinant varicella zoster virus (VZV) surface glycoprotein E (gE) and an adjuvant (i.e., AS01_B) and is used to boost active immunity to VZV.

Uses for Zoster Vaccine Recombinant

Prevention of Herpes Zoster

Prevention of herpes zoster (zoster, shingles) in adults ≥50 years of age.

Zoster is caused by reactivation of latent VZV infection in individuals who previously had varicella (chickenpox) infection. An estimated 500,000 to 1 million cases of zoster occur each year in the US; many patients develop postherpetic neuralgia (PHN) and require long-term management for refractory PHN. Risk of developing zoster increases with age and declining cell-mediated immunity to VZV. Zoster occurs principally in individuals >45 years of age; estimated lifetime risk of zoster is ≥32%, and 50% of individuals living until 85 years of age will develop zoster.

Zoster vaccine recombinant is used to boost active immunity to VZV, thereby reducing risk of VZV reactivation. May also reduce frequency and/or duration of PHN in those who develop zoster despite vaccination.

Not indicated for treatment of zoster or PHN. Do not administer during an acute episode of zoster. Has no role in postexposure management of zoster.

Not indicated for prevention of primary varicella infection (chickenpox); do not use in children or adults <50 years of age. Has no role in postexposure management of chickenpox.

There are 2 different types of zoster vaccine commercially available in the US for immunization against zoster in adults ≥50 years of age: zoster vaccine recombinant (RZV; Shingrix) and zoster vaccine live (ZVL; Zostavax).

For prevention of zoster in immunocompetent adults ≥50 years of age, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that zoster vaccine recombinant (not zoster vaccine live) is preferred and can be used in such individuals regardless of history of zoster or prior vaccination with varicella virus vaccine live or zoster vaccine live. The recombinant zoster vaccine also preferred in adults ≥50 years of age with certain chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease).

For prevention of zoster in immunocompetent adults ≥60 years of age, ACIP states that either zoster vaccine recombinant or zoster vaccine live can be used.

Zoster Vaccine Recombinant Dosage and Administration

Administration

Administer only by IM injection. Do not administer sub-Q, IV, or intradermally.

May be given concurrently with other age-appropriate vaccines. When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine using separate syringes and different injection sites. Injection sites should be separated by ≥1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.

Be aware that 2 different types of zoster vaccine are commercially available in the US (zoster vaccine recombinant [RZV; Shingrix] and zoster vaccine live [ZVL; Zostavax]). These vaccines have different recommendations for dosage and administration (e.g., different routes of administration, different number of required doses) and different storage requirements.

FDA alerted healthcare professionals about multiple reports of medication errors related to confusion about the 2 different zoster vaccines (e.g., incorrect reconstitution, incorrect route of administration, incorrect interval or number of vaccine doses, inappropriate age of vaccinee, administration after incorrect storage). Follow dosage and administration recommendations for the specific zoster vaccine used.

IM Administration

Administer reconstituted zoster vaccine recombinant by IM injection, preferably into deltoid region of upper arm.

To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique. Consider anatomic variability, especially in deltoid, and use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.

Reconstitution

Commercially available as a kit containing single-dose vials of lyophilized VZV gE antigen and single-dose vials of AS01_B adjuvant suspension.

Prior to administration, reconstitute a single-dose vial of lyophilized VZV gE antigen from the kit by adding entire contents of a single-dose vial of adjuvant suspension from the kit according to the manufacturer''s directions. After adding the adjuvant suspension component to the VZV gE antigen component, gently agitate to ensure the powder is completely dissolved. Reconstituted vaccine is an opalescent, colorless to pale brown liquid; discard if it contains particulates or appears discolored. Consult manufacturer’s labeling for additional information regarding preparation of zoster vaccine recombinant.

Administer immediately after reconstitution or store at 2–8° for up to 6 hours. Discard if not used within 6 hours. (See Storage under Stability.)

Dosage

Adults

Prevention of Herpes Zoster

Adults ≥50 Years of Age

Give zoster vaccine recombinant in a series of 2 doses. Each dose is 0.5 mL.

Give second dose 2–6 months after first dose.

Minimum interval between the 2 doses is 4 weeks. ACIP states repeat second dose if it was inadvertently given <4 weeks after first dose.

If interruptions or delays result in an interval >6 months between the 2 doses, ACIP states vaccine series does not need to be restarted; however, efficacy of dosing interval >6 months not evaluated to date.

A 2-dose regimen recommended regardless of history of zoster or prior vaccination with varicella virus vaccine live or zoster vaccine live.

If used in those who previously received zoster vaccine live, give zoster vaccine recombinant ≥2 months after zoster vaccine live.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Cautions for Zoster Vaccine Recombinant

Contraindications

• History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of the vaccine. (See Sensitivity Reactions under Cautions.)

Warnings/Precautions

Sensitivity Reactions

Take all known precautions to prevent adverse reactions, including a review of the patient’s history with respect to possible hypersensitivity to the vaccine or previous vaccine-associated adverse reactions.

Have appropriate medical treatment readily available in case an anaphylactic reaction occurs.

Individuals with Altered Immunocompetence

Individuals with altered immunocompetence were excluded from initial clinical trials evaluating safety and efficacy of zoster vaccine recombinant.

ACIP states that recombinant vaccines generally can be administered safely to individuals with altered immunocompetence.

Recommendations for use of recombinant vaccines in HIV-infected individuals usually are the same as those for individuals without HIV infection.

Immune response and efficacy may be reduced in individuals receiving immunosuppressive therapy. (See Specific Drugs under Interactions.)

Concomitant Illness

Base decision to administer or delay vaccination in an individual with a current or recent acute illness on severity of symptoms and etiology of the illness.

Do not administer zoster vaccine recombinant during an acute episode of zoster; defer vaccination until acute stage of the illness is over and symptoms have abated.

May be administered to age-appropriate adults with certain chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease).

ACIP states mild acute illness generally does not preclude vaccination.

ACIP states moderate or severe acute illness (with or without fever) is a precaution for vaccination; defer vaccine administration until individual has recovered from the acute phase of the illness. This avoids superimposing vaccine adverse effects on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccine administration.

Limitations of Vaccine Effectiveness

Does not prevent zoster in all vaccine recipients. In vaccinated individuals who develop zoster, duration of pain and discomfort may be reduced.

Duration of Immunity

Duration of protection against zoster following a 2-dose series of zoster vaccine recombinant not fully determined.

Data to date indicate duration of protection following a 2-dose series is at least 4 years; ACIP states that substantial protection against zoster is likely for >4 years.

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. (See Storage under Stability.)

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.

If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.

Specific Populations

Pregnancy

Data not available regarding use of zoster vaccine recombinant in pregnant women. In animal studies, no evidence that the vaccine or the AS01_B adjuvant component of the vaccine affects fetal development or causes fetal harm.

ACIP states consider deferring administration of zoster vaccine recombinant in pregnant women.

Lactation

Not known whether zoster vaccine recombinant vaccine is distributed into milk, affects milk production, or affects the breast-fed infant.

Consider benefits of breast-feeding and clinical importance of the vaccine to the woman along with potential adverse effects on the breast-fed child from the vaccine or the underlying maternal condition (i.e., susceptibility to reactivation of VZV infection).

ACIP states that recombinant vaccines generally do not pose any unusual risks for women who are breast-feeding or their breast-fed infants. However, these experts state consider deferring administration of zoster vaccine recombinant in women who are breast-feeding.

Pediatric Use

Safety and efficacy not established in pediatric patients. Not indicated for prevention of primary varicella infection (chickenpox).

Geriatric Use

Safety and efficacy established only in adults ≥50 years of age, including geriatric adults.

No clinically meaningful differences in efficacy among various age groups of adults ≥60 years of age or between those ≥60 years of age and those 50–59 years of age; adverse effects reported less frequently in vaccine recipients ≥70 years of age compared with those 50–69 years of age.

Common Adverse Effects

Injection site reactions (pain, erythema, swelling), myalgia, fatigue, headache, shivering, fever, GI symptoms (nausea, vomiting, diarrhea, abdominal pain).

Interactions for Zoster Vaccine Recombinant

Vaccines

Concurrent administration with other age-appropriate vaccines or toxoids during the same health-care visit (using separate syringes and different injection sites) not expected to affect immunologic responses or adverse reactions to any of the vaccines.

Specific Drugs

Stability

Storage

Parenteral

For Injectable Suspension, for IM Use

Vials containing lyophilized gE antigen: 2–8°; protect from light. Do not freeze; if freezing occurs, discard.

Vials containing AS01_B adjuvant suspension: 2–8°; protect from light. Do not freeze; if freezing occurs, discard.

Use immediately following reconstitution. Alternatively, reconstituted vaccine may be stored at 2–8°C for ≤6 hours; discard if not used within 6 hours. Do not freeze: if freezing occurs, discard reconstituted vaccine.

Actions

• Zoster vaccine recombinant is an inactivated (recombinant) vaccine used to boost immunity to VZV, thereby reducing the risk of reactivation of VZV and development of zoster and complications of the disease.

• Commercially available as a kit containing single-dose vials of lyophilized VZV gE antigen and single-dose vials of AS01_B adjuvant suspension. The VZV gE antigen component and the adjuvant component must be combined prior to administration (see Reconstitution under Dosage and Administration).

• The recombinant VZV gE antigen component is prepared using recombinant DNA technology and Chinese hamster ovary (CHO) cells. The adjuvant component is a liposomal formulation of AS01_B that enhances the immune response to the recombinant VZV gE antigen.

• Administration of a 2-dose vaccination series of zoster vaccine recombinant in adults ≥50 years of age boosts VZV-specific cell-mediated immune responses and VZV-specific humoral immunity resulting in a reduced risk of zoster and PHN in vaccinees. The immunologic response to a 2-dose regimen of the vaccine has been evaluated in adults ≥50 years of age with and without a history of zoster.

• Herpes zoster (zoster, shingles) and varicella (chickenpox) are distinct clinical entities caused by the same virus, VZV. During primary infection, VZV causes chickenpox; the virus invades sensory neurons and becomes latent in sensory nerve ganglia, establishing a source of potential secondary infection.

• Zoster is characterized by unilateral, painful, vesicular cutaneous eruption with a dermatomal distribution. Pain may occur during the prodrome, the acute eruptive phase, and the postherpetic phase of the infection (PHN). Serious complications of the disease (e.g., scarring, bacterial superinfection, allodynia, cranial and motor neuron palsies, pneumonia, encephalitis, visual impairment, hearing loss, death) may occur.

• Minimum immune response that correlates with protection against zoster not established.

Advice to Patients

• Prior to administration, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at [Web]).

• Advise patient of the risks and benefits of vaccination with zoster vaccine recombinant.

• Advise patient of the importance of receiving 2 doses of zoster vaccine recombinant given 2–6 months apart.

• Advise patient that zoster vaccine recombinant may not provide protection in all vaccinees.

• Inform patients about the potential for adverse reactions temporally associated with the vaccine. Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

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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Zoster vaccine recombinant, adjuvanted (Intramuscular)

Medically reviewed by Drugs.com. Last updated on Dec 5, 2022.

Commonly used brand name(s)

In the U.S.

• Shingrix

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

Uses for zoster vaccine recombinant, adjuvanted

Zoster vaccine recombinant, adjuvanted is used to prevent herpes zoster (shingles) in adults.

This vaccine is to be given by or under the direct supervision of your doctor.

Before using zoster vaccine recombinant, adjuvanted

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to zoster vaccine recombinant, adjuvanted or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of zoster vaccine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zoster vaccine in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Weak immune system—May decrease the effect of the vaccine and the body''s response to it.

Proper use of zoster vaccine recombinant, adjuvanted

A nurse or other trained health professional will give you zoster vaccine recombinant, adjuvanted. It is given as a shot into one of your muscles, usually in the deltoid (upper arm).

Zoster vaccine recombinant, adjuvanted is given as two doses. The second dose is given 2 to 6 months after the first dose. To get the best possible protection against herpes zoster infection, you should complete your vaccine dosing schedule.

Missed dose

Zoster vaccine recombinant, adjuvanted needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions while using zoster vaccine recombinant, adjuvanted

It is important that your doctor check your progress to make sure zoster vaccine recombinant, adjuvanted is working properly and to check for unwanted effects.

This vaccine may increase the risk for nervous system problems, including Guillain-Barré syndrome. Check with your doctor right away if you have sudden numbness and weakness in the arms and legs or inability to move the arms and legs.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Tell your doctor if you are receiving inactivated influenza vaccine.

Zoster vaccine recombinant, adjuvanted side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Ankle, knee, or great toe joint pain
• blindness
• blurred vision
• decreased vision
• eye pain
• fever greater than 39 degree Celsius
• joint stiffness or swelling
• lower back or side pain
• swollen, painful, or tender lymph glands in the neck, armpit, or groin

Incidence not known

• Hives, welts, or itching
• inability to move the arms and legs
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• sudden numbness and weakness in the arms and legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• difficulty in moving
• fever
• headache
• muscle aches, cramps, pains, or stiffness
• nausea
• pain, redness, and swelling at the injection site
• shivering
• stomach pain
• unusual tiredness or weakness
• vomiting

Less common

• Chills
• dizziness
• general feeling of discomfort or illness
• itching at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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