About the Vaccine
Shingrix Vaccine Composition
Shingrix (recombinant zoster vaccine) is a suspension for injection supplied as a single-dose vial of lyophilized gE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL. The shingles vaccine does not contain thimerosal (a preservative containing mercury).
Shingrix Vaccine Efficacy and Duration of Protection
Among immunocompetent adults 50 years and older, the efficacy of two doses of Shingrix for the prevention of herpes zoster (shingles) was high among all age groups. In a clinical trial of more than 30,000 participants, vaccine efficacy was 96.6% in adults aged 50 to 59 years, 97.4% in adults aged 60 to 69 years, and 91.3% in adults aged 70 years and older.
The efficacy of two doses of Shingrix for the prevention of postherpetic neuralgia (PHN) was high: 91.2% in adults aged 50 years and older, and 88.8% in adults aged 70 years and older.
Vaccine efficacy was estimated among several immunocompromised groups:
- 68.2% among adult autologous hematopoietic cell transplant recipients.
- 87.2% in a post hoc efficacy analysis of adult patients with hematologic malignancies.
- 90.5% in a post hoc efficacy analysis of adult patients with immune-mediated diseases who were not taking immunosuppressive medication.
In immunocompetent adults 70 years and older, vaccine efficacy remained high, at or above 84% in all 7 years after vaccination.
Side Effects and Counseling for Reactogenicity
In eight clinical trials of more than 10,000 immunocompetent participants 50 years or older, grade 3 reactions (vaccination-related reactions severe enough to prevent normal activities) were common after patients received Shingrix. About 1 out of 10 adults who received Shingrix reported grade 3 injection-site symptoms such as pain, redness, and swelling. Also, about 1 out of 10 reported grade 3 systemic reactions such as myalgia, fatigue, headache, shivering, fever, and gastrointestinal illness. Most people (78%) who got Shingrix reported at least some pain at the injection site.
Local and systemic grade 3 reactions among immunocompromised adults were evaluated in six studies in five immunocompromised groups. Local grade 3 reactions occurred in 10.7% to 14.2% of RZV recipients, and systemic grade 3 reactions occurred in 9.9% to 22.3% of RZV recipients, compared with 0% to 0.3% and 6.0% to 15.5%, respectively, among placebo recipients. The most commonly reported systemic symptoms were fatigue and myalgia.
Healthcare providers should counsel patients about expected reactogenicity before administering Shingrix.
Most people have a sore arm after they get Shingrix. Many people have redness and swelling on their arm spanning several inches where they got the shot. Many people also feel tired or have muscle pain, a headache, shivering, fever, stomach pain, or nausea.
About 1 out of 6 people had symptoms severe enough to prevent them from doing regular activities. Vaccine recipients should plan to avoid strenuous activities, such as yardwork or swimming, for a few days after vaccination.
Strongly recommend your patients get the second dose of the vaccine even if they experience these side effects to ensure maximum protection from shingles.
- If they have a reaction to the first dose of Shingrix, it does not necessarily mean they will have a reaction to the second dose.
- If they don’t have a reaction to the first dose, they might or might not have a reaction to the second dose.
- Remind your patients that the pain from shingles can last a lifetime, and these side effects should only last 2 to 3 days.
Vaccine recipients may take over-the-counter pain medicine like ibuprofen or acetaminophen to ease discomfort from these side effects. It is not recommended to take these medications before vaccination.
Severe Allergic Reactions
Severe allergic reactions to Shingrix are very rare. Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would start a few minutes to a few hours after the vaccination.
Any adverse events following vaccination can be reported to the Vaccine Adverse Event Reporting System (VAERS). Reporting is encouraged for any clinically significant adverse event even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at VAERS website, or by calling 1-800-822-7967.
Considerations for Patients Who Previously Received Zostavax
Studies have not examined the safety and immunogenicity of Shingrix administered less than 5 years following Zostavax (zoster vaccine live) vaccination. However, there are no data or theoretical concerns to indicate that Shingrix would be less safe or less effective when given at an interval shorter than 5 years following Zostavax. Since the risk of herpes zoster increases with age, providers should weigh a patient’s risk of herpes zoster with the age-specific protection expected from Zostavax to determine when to vaccinate with Shingrix.
- Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022.
- Clinical Considerations for Use of Recombinant Zoster Vaccine (RZV, Shingrix) in Immunocompromised Adults Aged ≥19 Years | CDC
- Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines, 2018.
- Package insert for Shingrix, U.S. Food and Drug Administrationpdf iconexternal icon
- Shingles Clinical Overview
- Shingles Vaccine Information Statement (Shingrix)
- Shingles Vaccine (Shingrix) Safety