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Last Updated: Jun 30, 2008 - 11:14:37 AM |
TURSDAY May 15, 2008 (foodconsumer.org) -- The Center for Disease Control and Prevention (CDC) recommends today that people age 60 and older should receive a vaccine to prevent a condition known as shingles or herpes zoster.
Shingles is caused by the varicella zoster virus which affects over 95 percent of people during their lifetime. The same virus causes the common childhood disease chickenpox and then becomes dormant within the nerves.
Shingles occur when the virus is reactivated due probably to weakened immune system causing cluster of blisters and pain that may last for weeks, months or years. One in every three persons is expected to have shingles during their lifetimes.
The CDC recommends a single dose of the zoster vaccine, known as Zostavax for adults 60 years of age and older. The federal health agency said the vaccine should be used even in those who have had a prior episode of singles.
The current recommendation effectually replaces an early provisional recommendation that the CDC made in 2006 after the vaccine was approved by the U.S. Food and Drug Administration and recommended by the CDC's Advisory Committee.
In terms of the efficacy, studies showed overall the vaccine reduced the occurrence of shingles in those aged 60 and older by about 50 percent and in those age 60 to 69 by 64 percent.
The side effects commonly seen in people who were given the Zostavax vaccine were redness, pain and tenderness, swelling at the site of injection, itching and headache, according to a statement issued by the CDC.
Shingles affect people age 50 and older. Among those aged 85, nearly half are affected by this condition. The risk of experiencing chronic pain also increases with age.
The vaccine got approval by the FDA in May 2006 and may cost about $150 a shot. According to healthday.com, the expense for the vaccine may not be covered by private insurance.
The following common questions and answer about Zostavax are cited from the FDA website for those who are interested in knowing more about the vaccine.
Zostavax™ Questions and Answers
Zostavax Product Information
1. 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.
2. 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.
3. 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.
4. 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.
5. How is Zostavax given?
Zostavax is given as a single dose by an injection under the skin, preferably in the upper arm.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. Does Zostavax contain thimerosal?
No. Zostavax does not contain thimerosal or any other preservative.
12. 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 1-800-822-7967 or report on line to www.vaers.hhs.gov
Updated: May 26, 2006
© 2004-2008 by foodconsumer.org unless otherwise specified
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