Shingles Overview and Vaccine Safety

Shingles (Herpes Zoster) Overview

Shingles is caused by the reactivation of the varicella zoster virus (VZV), which is the same virus that causes varicella (chickenpox). This usually occurs decades after the initial chickenpox infection. The reactivation of this virus causes a painful rash with clusters of fluid-filled blisters. Shingles is not contagious, but before the blisters dry, the virus-filled fluid can transmit chickenpox to someone who has not been previously exposed to the virus and comes in close contact with the open rash. Other symptoms of shingles can include fever, headache, chills, and an upset stomach.

Lasting for weeks, months, or even years, postherpetic neuralgia (PHN) is the most common complication of shingles, and can cause chronic, sometimes excruciating pain in the area where the rash occurred. This chronic, debilitating pain varies from mild to severe, disrupting one’s sleep, mood, and activities of daily living. PHN can reduce one’s quality of life, potentially leading to social withdrawal and depression; even suicide has been reported.

Scarring is another potential long-term complication of shingles, and in rare cases, a shingles infection can lead to pneumonia, hearing problems, blindness, brain inflammation (encephalitis), or death. While most people only have one episode of shingles, second and third episodes are possible.

For older individuals with MS, the risk of shingles and its complications is just as great as for those without MS – and for individuals with MS who take immunosuppressive medications, the associated risks become even greater. Everyone’s risk of shingles greatly increases as they get older, particularly after the age of 50. The risk of developing PHN (causing continued chronic pain) as a complication of shingles increases with age, as does the likelihood of experiencing longer lasting and more severe pain with PHN. Additionally, individuals with compromised or suppressed immune systems are also more likely to experience complications from shingles.

The Shingles Vaccine

According to the Centers for Disease Control and Prevention (CDC), the vaccine for shingles (also known as herpes zoster or zoster) is recommended for use in people 60 years and older to reduce the risk of shingles. This includes everyone in this age group who has no contraindications, as well as people who have had a previous episode of shingles and/or have chronic medical conditions. (The specific “chronic medical conditions” listed by the CDC include kidney failure, diabetes, rheumatoid arthritis, and chronic pulmonary disease.) The shingles vaccine was approved by the Food and Drug Administration (FDA) in 2006 and is marketed under the brand name Zostavax®.

The shingles vaccine is given in one dose, subcutaneously (under the skin) in the arm. Common side effects from the vaccine include redness, soreness, swelling, or itching at the shot site; and headache. After receiving the vaccination, individuals may be around infants and young children, pregnant women, or people with weakened immune systems; no reports have been made of someone getting chickenpox from another person who received the shingles vaccine. Some people may develop a chickenpox-like rash near the injection site. If this occurs, simply as a precaution, the rash should be covered until it disappears. The shingles vaccine does not contain thimerosal, which is a preservative that contains mercury and is sometimes used in vaccines.

No serious adverse events have been seen with the shingles vaccine, which has been tested in approximately 20,000 people (without MS) age 60 and older. The vaccine appears to be effective for at least six years, but may last longer. While older individuals may get the vaccine at any age, it appears to be the most effective in people 60 to 69 years. Studies have found that the shingles vaccine reduced the risk of shingles by 51 percent in older adults, reduced the risk of PHN by 67 percent, and also reduced the severity and duration of pain associated with PHN.

The safety of the shingles vaccine is more difficult to judge for individuals with MS. The current data supporting its use are reassuring, but not complete because this vaccine has not been fully investigated in MS. The shingles vaccine has been more thoroughly investigated in other illnesses, including patients whose immune system may be compromised by their disease or by the drugs used to treat their disease.

The shingles vaccine is a live, attenuated vaccine, which can be an issue for individuals with MS. Many vaccines use viruses that have been inactivated (i.e., killed), so the virus has no chance of infecting anyone. The shingles vaccine contains live viruses, but these have been “attenuated,” meaning that their strength has been reduced to a point where they can’t infect someone with a healthy, uncompromised immune system.

As with many individuals with various other health conditions, a large number of individuals with MS take medications that may modulate or suppress their immune system. A live-virus vaccine may conceivably be able to infect someone whose immune system is not fully functioning, a result of either an illness or medications given to treat an illness.

In addition to some of the FDA-approved long-term disease-modifying therapies for MS, large doses or extended use of steroids, which are frequently prescribed to treat MS relapses, can also suppress the immune system. Less common treatments to be considered when evaluating the safety of the shingles vaccine include: experimental treatments for MS, such as those being studied in clinical trials with MS patients; off-label treatments, such as methotrexate and Imuran® (azathioprine); hematopoietic stem cell transplantation (HSCT); and antiviral medications.

Guidelines for Shingles Vaccine Safety

According to an extensive report from the Advisory Committee on Immunization Practices (Harpaz R., et al, 2006), different treatments need to be considered before the shingles vaccine may be considered safe for an individual. This report originated in the National Center for Immunization and Respiratory Diseases, and the Division of Viral Diseases, both a part of the Centers for Disease Control and Prevention.

To follow are some general guidelines. As a reminder, individuals are strongly advised to consult their physician on the safety of the shingles vaccine, as doctors need to look at each person’s situation on a case-by-case basis.

Individuals who should not get the shingles vaccine, or who should wait, include:

Anyone who has ever had a life-threatening or severe allergic reaction to gelatin, the antibiotic neomycin, or another component of the shingles vaccine
An individual with a weakened immune system because of HIV/AIDS or other disease affecting the immune system, or someone who takes a medication that weakens the immune system
People on immunosuppressive therapy, including high-dose corticosteroids (20 mg or more per day of prednisone or equivalent) lasting two or more weeks, should wait for at least one month after discontinuing the therapy
Anyone with a moderate or severe acute illness (including anyone with a temperature of 101.3 degrees Fahrenheit or higher) should usually wait until they recover before getting a vaccine

Individuals who may receive the vaccine include:

Anyone with a minor acute illness (such as a cold) may be vaccinated
People receiving short-term corticosteroid therapy: for less than two weeks; in a low-to-moderate dose (less than 20 mg per day of prednisone or equivalent); topically (such as those given via nasal, skin, or inhaled administration); or long-term alternate-day treatment with low to moderate doses of short-acting systemic corticosteroids – these are all considered to not suppress the immune system enough to cause concerns for vaccine safety
Therapy with low-doses of methotrexate (equal to or less than 0.4mg/Kg/week) or azathioprine (equal to or less than 3.0 mg/Kg/day) is considered to not suppress the immune system enough to cause concerns for vaccine safety

Special groups and circumstances:

People who have previously had shingles may be vaccinated, although they need to wait until the rash is cleared
People with a normal immune system who are anticipating immunosuppression* (please see next bullet point), without a prior shingles vaccine, should receive the vaccine as soon as possible, while their immunity is intact; the vaccine should be administered at least 14 days before initiation of immunosuppressive therapy, although some experts advise waiting one month
*According to MSAA Chief Medical Officer Jack Burks, MD, “Most MS drugs are not considered immunosuppressive, but are considered immunomodulating, which affects the immune system differently. Nonetheless, we recommend that patients consult with their doctor regarding this CDC recommendation. For example, the recommendation for Gilenya® (fingolimod) is immunization 30 days before starting Gilenya.”
In regards to individuals receiving recombinant human immune mediators and immune modulators (especially the antitumor necrosis factor agents adalimumab, infliximab, and etanercept), the safety and efficacy of the shingles vaccine administered concurrently is unknown. If not possible to administer the vaccine before initiation of therapy, patients should have their immune status assessed by their physician to determine the relevant risks and benefits. Otherwise, vaccination should be deferred for at least one month after stopping the medication. (This category would include the MS medication Tysabri® [natalizumab], as well as many of the experimental therapies presently in clinical trials, such as Lemtrada® [alemtuzumab, formerly Campath], daclizumab [also known as Zenapax®], Rituxan® [rituximab], ocrelizumab, and ofatumumab [also known as Arzerra®]. Individuals taking one of these drugs are advised to talk to their doctor, who can assess the risks and benefits of the shingles vaccine in conjunction with this type of disease-modifying therapy.)
People receiving blood products (including antibody-containing blood products) may receive the shingles vaccine at any time before, during or after; the list includes intravenous immune globulin (IVIG); plasma exchange would also fall under this category, but is not specified in the report; patients receiving these types of treatment are advised to consult their physician before getting a shingles vaccine
Experience with individuals undergoing hematopoietic stem cell transplantation (HSCT) is limited and should be considered on a case-by-case basis; patients should have their immune status assessed by their physician to determine the relevant risks and benefits; if a shingles vaccine has been approved, it should not be administered until at least two years (24 months) after transplantation
Antiviral medications may interfere with the replication of the live-virus vaccine, so anyone taking Zovirax® (acyclovir), Famvir® (famciclovir), or Valtrex® (valacyclovir) regularly, should discontinue these medications at least 24 hours before administration of the shingles vaccine, if possible. These medications should not be used for at least 14 days after vaccination.

Additional Notes about the Shingles Vaccine

According to the CDC, the shingles vaccine may be given simultaneously with other vaccines, including the flu vaccine. Each vaccine must be administered using separate syringes and different injection sites. If other vaccines are not administered at the same time, the shingles vaccine may still be given at any time before or after other vaccines – provided these are inactivated vaccines. If receiving another live, attenuated vaccine (in addition to the shingles vaccine), and are not doing so at the same time, patients need to wait at least four weeks before or after the shingles vaccine, to receive a different live, attenuated vaccine.

The shingles vaccine is not recommended for anyone who has received the varicella (chickenpox) vaccine. However, the chickenpox vaccine did not become available in the United States until 1995, so virtually all people who have received a vaccination against chickenpox are too young to receive a shingles vaccine. For this reason, The CDC states that healthcare providers do not need to inquire about one’s varicella vaccination history, since virtually all persons in the recommended age group (and for at least the next decade) did not receive a chickenpox vaccine.

Additionally, the CDC notes that anyone 60 or older (without any contraindications) should get the vaccine, regardless of whether or not he or she can remember having had chickenpox. Studies show that 99.5 percent of Americans age 40 and over have had chickenpox. Patients do not need to be asked about their history of chickenpox or have their blood tested for antibodies.

Insurance Coverage and Resources

The following information is provided on the CDC’s website.
The shingles vaccine is available in pharmacies and doctors’ offices. To find local facilities that offer the vaccine, please visit www.zostavax.com.

All Medicare Part D plans cover the shingles vaccine; the cost-sharing for vaccination varies.

Medicare Part B does not cover the shingles vaccine.

Medicaid may or may not cover the vaccine.

Most private health insurance plans cover the vaccine for people age 60 and over; some cover people age 50 to 59.

The Merck Vaccine Patient Assistance Program provides free vaccines to eligible adults (usually individuals without insurance). For more information, please visit www.merck.com/merckhelps/vaccines/home.html or call (800) 293-3881.

Vaccine information statements are available in Spanish and other languages; please see www.immunize.org/vis

Interested individuals may also go to the CDC’s website for more information on shingles by visiting http://www.cdc.gov/vaccines/vpd-vac/shingles/default.htm

For more information on vaccines and MS, please refer to MSAA’s article, “Vaccine Safety and MS.”

For More Information

In addition to MSAA’s website, individuals may call MSAA at (800) 532-7667 for more information about MS and its treatments. Questions to MSAA’s Client Services Department may be emailed to MSquestions@mymsaa.org

References

Much of the information for this article was obtained through the Centers for Disease Control (CDC) and Prevention.

Harpaz R, et al, Recommendations of the Advisory Committee on Immunization Practices (ACIP), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, 2006.