About the Vaccine
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 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 age 50 to 59 years, 97.4% in adults age 60 to 69 years, and 91.3% in adults age 70 years and older. Vaccine efficacy remained high in adults age 70 years and older, at or above 84.7% in all four years after vaccination.
The efficacy of two doses of Shingrix for the prevention of postherpetic neuralgia (PHN) was high: 91.2% in adults age 50 years and older, and 88.8% in adults age 70 years and older.
In eight clinical trials of more than 10,000 participants, 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.
Healthcare providers should counsel patients about expected reactogenicity before administering Shingrix.
What to tell patients about the side effects of 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 felt tired or experienced 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. You should plan to avoid strenuous activities, such as yardwork or swimming, for a few days after vaccination. Remember that the pain from shingles can last a lifetime, and these side effects should only last 2 to 3 days.
The impact of prophylactic analgesics in conjunction with Shingrix has not been studied. However, you may suggest patients take over-the-counter ibuprofen or acetaminophen to ease discomfort from side effects.
If a patient has a reaction to the first dose of Shingrix it does not necessarily mean they will have a reaction to the second dose. If they do not have a reaction to the first dose they may or may not have a reaction to the second dose. Encourage patients to complete the series even if they experienced a grade 1-3 reaction to the first dose of Shingrix.
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 allergic reaction should be reported to the Vaccine Adverse Event Reporting System (VAERS). Healthcare providers can file this report, or patients can do it themselves through the VAERS websiteexternal icon, or by calling 1-800-822-7967.
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.
- Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines, 2018.Shingles Vaccine (Shingrix) Safety
- Package insert for Shingrix, U.S. Food and Drug Administrationpdf iconexternal icon
- Shingles Clinical Overview
- Shingles Vaccine Information Statement (Shingrix)
- Shingles Vaccine (Shingrix) Safety