Shingles (Herpes Zoster) Immunizations
The Shingles vaccine will be available sometime in November. Please give us a call to schedule an appointment for Shingles Immunization.
Shingles is a painful localized skin rash often with blisters that is caused by the varicella zoster virus (VZV), the same virus that causes chickenpox. Anyone who has had chickenpox can develop shingles because VZV remains in the nerve cells of the body after the chickenpox infection clears and VZV can reappear years later causing shingles. Shingles most commonly occurs in people 50 years old or older, people who have medical conditions that keep the immune system from working properly, or people who receive immunosuppressive drugs.
Shingles vaccine, was recently recommended by the Advisory Committee on Immunization Practices (ACIP) to reduce the risk of shingles and its associated pain in people 60 years old or older. The ACIP recommendation is being reviewed by the Director of CDC and the Department of Health and Human Services (HHS). Recommendations become official when published in CDC's Morbidity and Mortality Weekly Report (MMWR).
Zostavax™ Questions and Answers
- What is FDA announcing?
- FDA is announcing the licensing of Zostavax, a new vaccine that helps to reduce the risk of getting herpes zoster (shingles) in individuals 60 years of age and older. Zostavax is the only US licensed vaccine that reduces the risk of reactivation of the varicella zoster virus, the same one that causes chicken pox, and remains dormant in the body after recovering from this infection.
- What is herpes zoster (shingles) and how commonly does it occur?
- Anyone who has had chicken pox is at risk for developing shingles. It is estimated that 1 million or more cases occur each year in the United States. Shingles can occur in people of all ages, but most commonly in those over 60 years of age, and this risk increases as people get older. When shingles develop, a rash or blisters appear on the skin, generally on one side of the body. This is a sign that the virus, that has been dormant in the nerve cells, has reactivated and traveled from the nerves and followed a path out to the skin. Because the nerves along the path become inflamed, shingles can also be painful. Pain that lasts for months after the rash has healed is called post herpetic neuralgia or PHN. For some people, this pain can be severe and chronic.
- Does Zostavax help with post herpetic neuralgia?
- In people who were 70 years of age and older, and still developed shingles, even though they had been vaccinated, Zostavax reduced the frequency of PHN, the pain associated with the illness. Overall, the benefit of Zostavax in preventing PHN is due to the effect of the vaccine on reducing the risk of developing herpes zoster (shingles). Zostavax will not work to treat PHN.
- What causes herpes zoster (shingles)?
- The causes aren't completely known, but it is thought that a combination of factors can trigger shingles, including age and problems with the immune system.
- How is Zostavax given?
- Zostavax is given as a single dose by an injection under the skin, preferably in the upper arm.
- How well does Zostavax work to prevent herpes zoster (shingles)?
- The studies for Zostavax enrolled approximately 38,000 people throughout the United States who were 60 years of age and older; approximately half received Zostavax and half received placebo. Study participants were followed on average for about three years to see if they developed shingles and if they did, how long the pain lasted.
At the conclusion of the studies, researchers found that overall (in persons age 60 years and older) the vaccine reduced the occurrence of herpes zoster (shingles) by about 50%. The vaccine effect was highest at 64% in people between the ages 60-69, but its effectiveness declined with increasing age; to 41% for the 70-79 age group, and 18% for those 80 years of age and older.
In those who were vaccinated with Zostavax, but still developed shingles, the duration of pain was a bit shorter for them versus those who received a placebo. Specifically, the pain of those in the Zostavax group lasted on average for 20 days and for those who received placebo, it lasted for about 22 days. The severity of the pain did not appear to differ among the two groups.
- Are there any possible adverse reactions associated with the use of Zostavax?
- In the largest study that was conducted to look at safety, rates of serious adverse events were similar in people who received Zostavax (1.4%) compared to those who received the placebo (1.4%).
As part of this larger study, a smaller study was conducted to look more closely at safety. In this smaller study, serious adverse events were noted more frequently in those who received Zostavax (1.9%) than in those who received placebo (1.3%). The numbers of deaths in each group were similar. Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the manufacturer will perform a Phase 4 (postmarket) study to provide additional safety information.
The following common side-effects were reported more often in people who received Zostavax when compared to those who received placebo: redness, pain and tenderness, swelling at the site of injection of the vaccine and headache.
- Who should not be immunized with Zostavax?
- People who are allergic to neomycin, or any component of the vaccine should not receive Zostavax. Zostavax is a live vaccine and should not be given to individuals who have a weakened immune system caused by treatments that they are taking such as radiation, a class of drugs called corticosteroids, or due to conditions such as AIDS, cancer of the lymph, bone or blood.
In addition, Zostavax should not be used by women who are or may be pregnant.
Zostavax should not be used in children and it is not a substitute for Varivax, the vaccine to prevent chicken pox.
In addition, people who are in close contact with pregnant women who have not had chickenpox should talk to their healthcare provider to decide if using Zostavax is right for them.
- Should Zostavax be used in people who are under 60 years of age?
- At this time, there is not enough information from the studies to determine the risks and benefits of Zostavax in people younger than 60 years of age.
- Should someone who has already had shingles use the vaccine, so that they don't get them again?
- No. Zostavax has not been studied among people who have had shingles, and the effectiveness in preventing repeated episodes is unknown. However, it is unlikely that persons who have had shingles will suffer another episode.
- Does Zostavax contain thimerosal?
- No. Zostavax does not contain thimerosal or any other preservative.
- How can I report a serious side effect with Zostavax, or other vaccines, to FDA?
- Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention. For a copy of the vaccine reporting form, call 1-800-822-7697 or report on line to www.vaers.hhs.gov
Updated: May 26, 2006 - U.S. Food & Drug Administration