Shingrix Vaccine

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Shingrix Vaccine

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Shingrix Vaccine

Property Description
Active ingredient VZV glycoprotein E (gE) antigen (recombinant)
Form Lyophilized powder and suspension for injection
Pharmacological class Viral Vaccines (Non-live)
Common use Prevention of Herpes Zoster (Shingles)
Origin Biologic drug, Recombinant subunit type

What Type of Medicine is the Zoster Vaccine Recombinant?

The Zoster Vaccine Recombinant, Adjuvanted (RZV) is a modern non-live vaccine classified within the high-level Viral Vaccines pharmacological class. This product is a specialized recombinant subunit vaccine, meaning it contains only a highly purified, manufactured component of the virus rather than the whole virus. Because it is non-live, it cannot cause the disease it is designed to prevent.

RZV is considered a biologic drug whose active component, the glycoprotein E (gE) antigen, is produced using advanced recombinant DNA technology. This approach is clinically recognized for stimulating the immune system to generate a strong and sustained immune response, a key differentiating factor from older live attenuated zoster vaccines. The formulation is provided as a lyophilized powder and suspension that is combined just before being administered as an intramuscular injection.


Key Components: Glycoprotein E and the Adjuvant System AS01B

The vaccine’s active ingredient is the purified Varicella Zoster Virus (VZV) glycoprotein E (gE) antigen. RZV is a combination product where the antigen component is intentionally paired with the proprietary Adjuvant System AS01B. This adjuvant system contains two components, QS-21 and MPL, which are designed to enhance the magnitude and duration of the body's defensive response.

This adjuvant system is essential for stimulating robust VZV-specific T-cell responses, particularly in older adults. This mechanism helps ensure the immune system mounts a necessary, strong defense, even when natural immune response has weakened with age.


Primary Purpose: Prophylaxis Against Shingles and PHN

The fundamental therapeutic use of the RZV vaccine is strictly prophylactic, or preventative, against the reactivation of the Varicella Zoster Virus. Its overarching purpose is to reduce the risk of developing Herpes Zoster (shingles). For example, it is typically recommended for adults 50 years and older to reduce their lifetime risk of VZV reactivation.

Furthermore, by preventing the shingles rash, the vaccine also aims to protect against the most common and debilitating complication of shingles: Post-Herpetic Neuralgia (PHN), which is severe, long-term nerve pain that persists after the rash has cleared.

Regulatory References

  1. Shingrix (Zoster Vaccine Recombinant, Adjuvanted) Prescribing Information

What side effects are possible with Shingrix Vaccine?

Possible Side Effects and Safety Information

The safety profile of the Recombinant Zoster Vaccine (RZV) is based on official regulatory data that classifies adverse reactions by frequency and affected body system. Most reported reactions are indicators of the body developing an immune response and are typically transient.

Adverse Reaction Frequencies

The most frequent adverse events are categorized as Very Common (affecting ge 1/10 individuals) and generally resolve within two to three days. The frequency of both local and systemic reactions is documented as typically higher following the second dose of the vaccine compared to the first dose.

Frequency Classification Local Reactions (at Injection Site) Systemic Reactions
Very Common Pain, Redness, Swelling Myalgia, Fatigue, Headache, Chills, Fever, Gastrointestinal symptoms
Common Pruritus (Itching) Malaise

Systemic and Serious Effects

Adverse reactions are classified into System-Organ Classes (SOC) including General Disorders, Musculoskeletal, Nervous System Disorders (Headache), and Gastrointestinal Disorders. Less common effects include Lymphadenopathy (swelling of lymph nodes) and Hypersensitivity reactions (e.g., Urticaria).

Serious adverse reactions documented in official labeling include Anaphylaxis, a severe immediate allergic reaction, and an observed increased risk of Guillain-Barré Syndrome (GBS) in post-marketing surveillance. The vaccine is contraindicated in individuals with a known history of a severe allergic reaction to any component of the formulation.

Population Safety Notes

Regulatory safety statements confirm that the adverse reaction profile in immunocompromised adults (18+) is generally consistent with that in older adults, though some reactions may be reported at a higher incidence in younger immunocompromised individuals. Caution is advised for administration to individuals with coagulation disorders due to the injection procedure.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for the Zoster Vaccine Recombinant, Adjuvanted (Shingrix) does not define a specific toxicological syndrome or unique set of clinical manifestations resulting from over-administration. Unlike pharmaceutical small-molecule drugs, the regulatory information regarding this non-live recombinant vaccine focuses on mandated management actions rather than dose-dependent clinical signs. This regulatory approach indicates that no specific symptoms or laboratory abnormalities unique to an overdose are formally described in government prescribing information. Furthermore, the official label confirms that no specific antidote is known or documented for managing over-administration.

Mandatory Emergency Protocol

Regulators unequivocally mandate that individuals seek immediate medical attention or urgent medical attention if over-administration is suspected or confirmed. This action is required immediately, even if there are no signs or symptoms of discomfort or adverse effects, reflecting a precautionary standard across official regulatory documents. The explicitly required action is to contact a healthcare professional, the nearest hospital emergency department, or a regional poison control center for a comprehensive medical evaluation. The official documentation confirms that management involves providing necessary symptomatic and supportive treatment under clinical observation.

Therapeutic Uses of Shingrix Vaccine

What Shingrix Vaccine Treats: Main Uses and Benefits

The primary therapeutic domain of the Recombinant Zoster Vaccine is the prevention of Herpes Zoster (shingles), which is associated with symptoms related to heightened physiological activity caused by the Varicella Zoster Virus (VZV). This intervention may help lessen the overall risk of experiencing the initial, painful episode characterized by a severe, localized blistering rash and intense acute pain. The vaccine is generally a preventative measure used in routine adult vaccination to help lessen the risk of this primary event.

A key therapeutic domain is the prevention of a primary, severe outcome: Post-Herpetic Neuralgia (PHN). This complication involves chronic, severe nerve pain that persists long after the initial rash has cleared. By providing supportive protection against the disease, the vaccine may assist with maintaining functional stability and comfort by helping to address the development of this debilitating chronic pain state.

Shingrix is commonly used for adults aged 50 years and older, and is considered relevant for adults aged 18 and older who are immunocompromised. The therapeutic applications are focused on two main indications: the prevention of Herpes Zoster and the avoidance of Post-Herpetic Neuralgia. This supports patients in obtaining protection against a painful and potentially serious recurrent viral condition.


Quick Fact: Prevention of Chronic Neuropathic Pain

Eligibility and Restrictions for Use

The Shingrix vaccine is recommended for the prevention of herpes zoster (shingles) and its complications in specific adult populations.


Who Should Get Vaccinated?

Shingrix is typically recommended for:

  • Adults aged 50 years and older. This recommendation stands regardless of whether an individual has previously had shingles or received the older Zostavax vaccine.
  • Adults aged 18 years and older who are, or will be, immunocompromised (at increased risk of shingles due to disease or therapy). Since Shingrix is a non-live, recombinant vaccine, it is suitable for this population.

Who Should Not Get Vaccinated (Contraindications)?

Shingrix should not be administered to individuals who:

  • Have a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix.
  • Are experiencing a current, acute episode of shingles (vaccination should be deferred until the rash has cleared and symptoms have abated).
  • Are currently pregnant. The vaccine is not generally recommended during pregnancy as there is insufficient data to establish its associated risk in this group.

Vaccination should also generally be deferred if a person has a moderate or severe acute illness.

What should I know about interactions with other medicines?

The Shingrix (Zoster Vaccine, Recombinant, Adjuvanted) vaccine is not known to have significant direct interactions with most common medications, including antivirals (like valacyclovir) or many over-the-counter drugs. Its action, which involves stimulating an immune response, is generally separate from the pharmacological effects of most other medicines.

However, a key consideration for the effectiveness of the vaccine is the use of immunosuppressive therapies. These treatments—which include high-dose corticosteroids, chemotherapy, and certain disease-modifying antirheumatic drugs (DMARDs)—may reduce the immune response to Shingrix, potentially lowering the protection provided. It is essential to discuss all medications with a healthcare provider, especially those affecting the immune system, to determine the optimal timing for vaccination.

Co-administration with Other Vaccines

Shingrix may be administered concomitantly (at the same time) with several other adult vaccines, including the seasonal influenza vaccine (inactivated), pneumococcal vaccines (PCV13 and PPV23), and the Tdap (tetanus, diphtheria, and acellular pertussis) vaccine. This concurrent administration should occur at different injection sites. Co-administration may increase the frequency of common, generally mild, local and systemic adverse events, such as fever or shivering, compared to receiving Shingrix alone.

Mechanism of Action

Shingrix is a non-live, recombinant subunit vaccine that functions by engaging the adaptive immune system against the Varicella-Zoster Virus (VZV). Its mechanism targets key immunological domains to support the development of durable cellular and humoral immunity.

Recombinant Antigen Targeting

This mechanism is initiated by the Glycoprotein E (gE) antigen, the vaccine's primary biological target and a key VZV surface protein. The purified gE protein is taken up by antigen-presenting cells, initiating signaling sequences that instruct the immune system to recognize the VZV antigen. This process supports the initiation of immunological memory.

Adjuvant-Mediated Pathway Potentiation

The vaccine incorporates the proprietary AS01B adjuvant system, which modulates key innate immune pathways. AS01B actively triggers localized signaling cascades, recruiting and activating immune cells more intensely than the gE antigen alone. This effect modifies early molecular steps and supports the magnitude and persistence of the immune response.

Dual Cellular and Humoral Defense

The core physiological effect of this mechanism is the simultaneous development of cellular immunity (T-cells) and humoral immunity (antibodies) specific to the VZV. The resulting memory T-cell activity supports the modulation of VZV latency within neural tissues by contributing to the control of VZV viral load.

Dosage and Administration Information

Administration Process

The Shingrix vaccine is administered as an intramuscular injection. The preferred site for the injection is the deltoid muscle of the upper arm. The vaccine is provided as a two-component product consisting of a vial of lyophilized antigen powder and a vial of adjuvant suspension liquid.

Before administration, a healthcare professional reconstitutes the vaccine by withdrawing the entire contents of the adjuvant suspension vial into a syringe and injecting it into the vial containing the antigen powder. The vial is then gently shaken until the powder is completely dissolved. The resulting liquid should appear opalescent and colorless to pale brownish.

Schedule and Series Completion

The vaccination series consists of two distinct doses. To ensure the intended immune response, it is necessary for individuals to receive both doses of the series.

  • First Dose: The initial injection is administered at a selected date.
  • Second Dose: The follow-up injection is administered after the first dose. The timing of this second dose is determined by a healthcare provider based on the individual’s health status and specific medical considerations.

Storage and Handling

Proper handling of the vaccine components is necessary to maintain stability. Both the antigen vial and the adjuvant vial must be refrigerated. The vaccine should not be frozen; if either component has been frozen, it should not be used. After reconstitution, the vaccine is typically administered immediately. If immediate use is not possible, the reconstituted vaccine is stored under refrigeration and must be used within a specific, limited timeframe or discarded.

Recent Clinical Evidence

Research evidence / Overview of Studies for Shingrix Vaccine


Evidence for Prevention of Herpes Zoster (Shingles) in Generally Healthy Adults (Ages 50+)

Research examining the incidence of shingles (Herpes Zoster, HZ) was primarily based on large-scale Randomized, Placebo-Controlled Trials (RCTs). These studies were used in research examining the incidence of HZ cases in this generally healthy population. Outcomes related to episodic or acute changes were monitored in the observed populations for several years to track the number of confirmed HZ cases.

Findings describe patterns observed in the studies conducted in these groups. The research highlights changes measured during the study period across different older age strata, including adults aged 70 and older. The results apply only to the generally healthy populations studied under the specific conditions of the trials, as the primary RCTs largely excluded individuals with a prior history of shingles or conditions that compromise the immune system.


Evidence for Prevention of Post-Herpetic Neuralgia (PHN)

Research explored the outcomes related to chronic, debilitating nerve pain known as Post-Herpetic Neuralgia (PHN), which was evaluated as an outcome related to physical discomfort. Studies focused on whether the frequency of this long-term complication was affected, with PHN defined in the trials as pain persisting for 90 days or longer after the shingles rash had cleared.

Research described the PHN incidence patterns observed in the studied groups compared to the placebo groups in the large trials. The evidence contributes to understanding symptom patterns, as the research monitored the number of HZ cases, a factor related to PHN.


Evidence in Immunocompromised Adults

Research has explored the use in special populations that are subject to underlying health conditions or medical treatments known to cause immune changes. Studies monitored outcomes in specific, higher-risk cohorts of adults aged 18 and older, including autologous hematopoietic cell transplant (HCT) recipients and individuals with certain hematologic malignancies.

Evidence in this area is limited and data are still emerging. The research is drawn from a highly heterogeneous population, meaning the underlying diseases and immunosuppressive treatments varied widely across studies.

Frequently Asked Questions (FAQ)

Common questions about Shingrix Vaccine (FAQ)


Q: Does Shingrix contain any preservatives or latex?

According to the official product information filed with the FDA, Shingrix does not contain any preservatives. Furthermore, regulatory documents specify that the vial stoppers used for the vaccine formulation do not contain natural rubber latex.


Q: Is the Shingrix Vaccine safe for people with a weakened immune system?

Official regulatory documents describe the vaccine as indicated for use in adults aged 18 and older who are at an increased risk of shingles due to certain diseases or therapies that cause a weakened immune system. This indication is provided because the vaccine is a non-live recombinant type.


Q: What is the main difference between Shingrix and the previous shingles vaccine, Zostavax?

The primary distinction is that Shingrix is a non-live, recombinant subunit vaccine that contains only a viral component, while the previous vaccine, Zostavax (now discontinued in the U.S.), was a live, attenuated vaccine. Additionally, Shingrix is administered as a two-dose series, unlike the single-dose Zostavax.


Q: Has the Shingrix Vaccine been studied in people with chronic health conditions like diabetes or COPD?

While the large efficacy studies focused on generally healthy populations, official health resources note that conditions like diabetes and COPD are associated with a higher risk of developing shingles. Official guidelines typically recommend the vaccine for individuals aged 50 and older who have these or other underlying chronic health conditions.


Q: What is known about the durability of the Shingrix Vaccine’s protection?

Studies and official information indicate that the protection provided by the vaccine is durable. Follow-up research has shown that high efficacy against shingles was observed in studies that tracked older adults for up to approximately 11 years after completing the two-dose series.


Q: Does Shingrix require a booster shot later on?

According to current official guidelines from health authorities, a booster dose of Shingrix is not currently recommended. Adults generally only need to receive the full two-dose primary series once for protection against shingles.


Q: Can people with certain food or drug allergies receive the Shingrix Vaccine?

Official information states that the only absolute contraindication is a history of a severe allergic reaction, such as anaphylaxis, to any component of the vaccine itself or to a previous dose. General food or drug allergies are not listed in regulatory documents as a reason to avoid the vaccine.


Q: Is there an age limit for getting the Shingrix Vaccine?

The vaccine is officially indicated for use in adults starting at age 50 years and older (or 18 years and older if immunocompromised). However, official product information and health guidelines do not specify a maximum age limit for receiving the vaccine.


Q: Why is the Shingrix Vaccine given as a two-dose series?

The vaccine is administered as a two-dose series because clinical trials and efficacy results were established based on this schedule. This specific series was studied to stimulate the immune system and generate the strong, sustained defense that has been documented in research.


Q: Why do some people experience pain at the injection site from Shingrix?

Pain at the injection site is reported as a very common, temporary side effect. This reaction is understood to be the result of the vaccine's adjuvant system, which is designed to stimulate a robust immune response. This intense activation is the likely reason for the localized pain and swelling, which typically resolves within a few days.


Q: Is there a waiting period between receiving the COVID-19 vaccine and Shingrix?

Current public health guidance states that the Shingrix vaccine and the COVID-19 vaccine may be given at the same time without any required waiting period. This is because both are non-live vaccines, and official information advises that they may be administered without regard to timing.


Q: How soon after the first dose does the Shingrix Vaccine offer protection?

Clinical trials primarily measured the vaccine's full efficacy starting one month after the second dose. Official product information does not specify a defined level or onset of protection immediately following only the first dose. The demonstrated high protection was established upon the completion of the full two-dose series.


Q: How long does protection from the Shingrix Vaccine last, according to studies?

Studies have examined the persistence of the vaccine's effects over time. Efficacy against shingles was observed to remain high in follow-up data that tracked older adults for up to approximately 11 years after the two-dose series.


Q: What is the reported effectiveness of the Shingrix Vaccine in different age groups?

Data from clinical trials describe the vaccine's efficacy at preventing shingles. It was approximately 97% effective in adults aged 50–69 and approximately 91% effective in adults aged 70 years and older.


Q: Why did official guidelines change from Zostavax to Shingrix?

Official guidelines recommend Shingrix primarily because of the efficacy percentages documented in clinical trials compared to the previous vaccine, Zostavax. The non-live status of Shingrix also makes it described as suitable for a wider range of individuals, including those who are immunocompromised.


Q: Is Shingrix a required vaccine for adults?

Shingrix is classified by public health authorities as a recommended vaccine for certain adult populations, including those aged 50 and older and those aged 18 and older who are immunocompromised. It is not generally considered a required or mandatory vaccine.


Q: Is Shingrix approved for use in countries outside of the US?

Yes, the vaccine has received regulatory approval and is used in immunization programs in many countries outside the US. This includes countries under the jurisdiction of the European Medicines Agency (EMA) and other government-run health authorities globally.


Q: Why is the Shingrix Vaccine given by injection rather than orally?

The official administration method for the vaccine is a suspension given by intramuscular (IM) injection only. This route is standard for this type of recombinant subunit vaccine because it is where the intended immune response is designed to be most effectively triggered.


Q: What kind of research evidence supports the long-term use of Shingrix?

Research supporting the vaccine's use includes long-term clinical trials that have tracked participants for an extended period. These studies have documented the persistence of high vaccine efficacy throughout the follow-up period, which has been up to approximately 11 years after the initial vaccination.

How should Shingrix Vaccine be stored and disposed of?

How to Store and Dispose of Shingrix Vaccine?

The storage and disposal of the Shingrix vaccine are strictly governed by official regulatory requirements to maintain product integrity.


Storage and Handling

Requirement Condition
Temperature Store refrigerated between 2°C and 8°C (36°F and 46°F).
Freezing Do not freeze; the product must be discarded if frozen.
Light Protection Keep in the original package to protect from light.
Child Safety Store out of the sight and reach of children.

Stability and Disposal

The vaccine components are supplied in two separate vials (powder and suspension). Once the product is mixed (reconstituted), it must be used within 6 hours, even if refrigerated. Any unused or expired vaccine must be handled and disposed of safely by a healthcare professional (doctor, nurse, or pharmacist) in accordance with local regulations for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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