Herpes Zoster (Shingles) Vaccine Recommendations and Safety

Herpes Zoster (Shingles) Vaccination Recommendations

As of September 2018, there are currently ordering limits and intermittent shipping delays for GlaxoSmithKline’s Shingrix vaccine (Recombinant Zoster vaccine) due to high demand. Until demand can be met, it is particularly important that vaccine providers educate patients about the importance of completing the series. In addition, CDC reminds health care professionals of proven strategies to help patients receive all their needed vaccinations on time, including Shingrix:

  • Implement a vaccine reminder and recall system using phone, e-mail, or text messages to contact patients when you have Shingrix supply. Give first consideration to patients due for their second dose of Shingrix (https://www.thecommunityguide.org/findings/vaccination-programs-client-reminder-and-recall-systems).
  • If you are out of Shingrix and a patient needs a second dose, refer the patient to another provider in the community (e.g., a pharmacy) that has Shingrix so the patient can complete the series. The immunization program at your state or local health department or vaccine finder can help identify other immunization providers (https://vaccinefinder.org).
  • Be sure to enter your patients’ current vaccination information into your state’s immunization information system (IIS). This will ensure that every provider can access your patients’ immunization record, and it may help facilitate patient reminders to complete the Shingrix series.
  • As supply becomes less constrained, be sure to notify eligible patients so they can come in to get their first dose of Shingrix.

Timely series completion is key to the success of any vaccination program and critical to ensuring patients receive the full benefit of their vaccinations.

Shingles vaccination is the only way to protect against shingles and postherpetic neuralgia (PHN), the most common complication from shingles. In 2017 a new vaccine to prevent shingles was licensed by the FDA: Shingrix®.

CDC recommends Shingrix® (recombinant zoster vaccine) as preferred over Zostavax® (zoster vaccine live) for the prevention of herpes zoster (shingles) and related complications. CDC recommends two doses of Shingrix separated by 2 to 6 months for immunocompetent adults age 50 years and older:

  • Whether or not they report a prior episode of herpes zoster
  • Whether or not they report a prior dose of Zostavax
  • Who have chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease), unless a contraindication or precaution exists. Similar to Zostavax, Shingrix may be used for adults who are
  • are taking low-dose immunosuppressive therapy
  • are anticipating immunosuppression
  • have recovered from an immunocompromising illness
  • Who are getting other adult vaccines in the same doctor’s visit, including those routinely recommended for adults age 50 years and older, such as influenza and pneumococcal vaccines. The safety and efficacy of concomitant administration of two adjuvanted vaccines, such as Shingrix and Fluad, have not been evaluated.

It is not necessary to screen, either verbally or by laboratory serology, for evidence of prior varicella infection. 

Zostavax remains a recommended vaccine for prevention of herpes zoster in healthy adults 60 years and older and may be used in certain cases, such as when a patient prefers Zostavax or is allergic to Shingrix.

The shingles vaccine is specifically designed to protect people against shingles and will not protect people against other forms of herpes, such as genital herpes. The shingles vaccine is not recommended to treat active shingles or post-herpetic neuralgia (pain after the rash is gone) once it develops.

Current ACIP Vaccine Recommendations: Zoster

Shingrix Vaccine Safety

Serious adverse events (an undesirable experience associated with the vaccine that results in death, hospitalization, disability or requires medical or surgical intervention to prevent a serious outcome) were examined in eight studies sponsored by GSK, which included 29,965 subjects (15,264 RZV recipients). Overall, rates of serious adverse events over the study periods were similar in the RZV and placebo groups.

Injection-site and systemic grade 3 solicited adverse events (reactions related to vaccination which were severe enough to prevent normal activities) were actively surveyed in eight studies involving 10,590 subjects. Among the subset of subjects completing the 7-day diary card for reactogenicity in phase III clinical trials (9,936), 16.5% of vaccine recipients reported any grade 3 adverse event compared with 3.1% of placebo recipients. Grade 3 injection-site reactions (pain, redness, and swelling) were reported by 9.4% of vaccine recipients, compared with 0.3% of placebo recipients and grade 3 solicited systemic events (myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms) were reported by 10.8% of vaccine recipients and 2.4% of placebo recipients. Whereas there were no differences in the proportions of local grade 3 reactions between dose 1 and dose 2, systemic grade 3 reactions were reported more frequently after dose 2. Overall, the most common solicited adverse reactions (grade 1–3) were pain (78%), myalgia (45%), and fatigue (45%).

Side Effects and Counseling for Reactogenicity

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. You can say things like, “Most people got a sore arm after getting Shingrix. Some people had redness and swelling in the place where they got the shot. You might also feel tired or experience some muscle pain, a headache, or shivering. The symptoms were severe enough to prevent regular activities for about 17% of people who got the vaccine. All these symptoms should pass in two to three days.” The impact of prophylactic analgesics in conjunction with Shingrix has not been studied.

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

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 website, or by calling 1-800-822-7967.

Sources: https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm and https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/about-vaccine.html

Some people should NOT get shingles vaccine.

Shingrix should not be administered to:

  • A person with a history of severe allergic reaction, such as anaphylaxis, to any component of a vaccine or after a previous dose of Shingrix
  • A person who is known to be seronegative for varicella
  • It is not necessary to screen (either verbally or via laboratory serology) for a history of varicella. However, if a person is known to be varicella-negative via serologic testing, providers should follow ACIP guidelines for varicella vaccination.
  • A person experiencing an acute episode of herpes zoster. Shingrix is not a treatment for herpes zoster or postherpetic neuralgia (PHN). The general guidance for any vaccine is to wait until the acute stage of the illness is over and symptoms abate.

Shingrix has not been studied in pregnant women or women who are breastfeeding. Providers should consider delaying Shingrix vaccination for these women.

Adults with a minor acute illness, such as a cold, can receive Shingrix. Adults with a moderate or severe acute illness should usually wait until they recover before getting the vaccine. This includes anyone with a temperature of 101.3°F or higher.

To learn more, see Contraindications and Precautions, General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP).

For more information on herpes zoster and immunization, see the Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines, 2018.

 Source: https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html

 

Updated 1/26/18

 

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