Pharmaceutical Name

Trade (marketing or proprietary) name: SHINGRIX

Generic (nonproprietary or active ingredient) name: Zoster Vaccine Recombinant, Adjuvanted suspension for intramuscular injection

Indication and Usage

Reason the product has been approved for sale on the market.

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

• in adults aged 50 years and older.
• in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Each 0.5-mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS-21. Each dose also contains 20 mg of sucrose (as stabilizer), 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. Each dose may also contain residual amounts of host cell proteins (≤3.0%) and DNA (≤2.1 picograms) from the manufacturing process.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Do not administer SHINGRIX to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Preventing and Managing Allergic Vaccine Reactions: Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX.

Guillain-Barré Syndrome (GBS): In a postmarketing observational study, an increased risk of GBS was observed during the 42 days following vaccination with SHINGRIX.

Syncope: Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Angioedema, Rash, Urticaria (hives), Decreased mobility of the injected arm which may persist for 1 or more weeks, Gastrointestinal symptoms, Myalgia, Fatigue, Shivering, Fever, Guillain-Barré Syndrome, Syncope: visual disturbance, paresthesia, and tonic-clonic limb movements.

Limitations of Effectiveness

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Specific Populations

Pregnancy

The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women.

Breastfeeding

It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion.

Pediatric

Safety and effectiveness in individuals younger than 18 years have not been established. SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

The risk of developing HZ, which increases with age and with immunosuppression due to disease and/or therapy, appears to be related to a decline in varicella zoster virus (VZV) specific immunity. SHINGRIX was shown to boost VZV-specific immune response, which is thought to be the mechanism by which it protects against zoster disease.

Analytical Deep Dive

What is informed consent?

Alternatives

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