FDA Approves Vaccine for Shingles

Discussion in 'Fibromyalgia Main Forum' started by mme_curie68, May 25, 2006.

  1. mme_curie68

    mme_curie68 New Member

    Part of my "program" trying to pass on FDA info of use...

    FOR IMMEDIATE RELEASE Media Inquiries: Heather Howell
    P06-73 301-827-6242
    May 26, 2006 Consumer Inquiries: 888-INFO-FDA



    FDA Licenses New Vaccine to Reduce Older Americans’ Risk of Shingles

    The Food and Drug Administration (FDA) licensed Zostavax, on May 25, 2006, a new vaccine to reduce the risk of shingles (herpes zoster) for use in people 60 years of age and older.

    Shingles is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerve tissue. As people age, it is possible for the virus to reappear in the form of shingles, which is estimated to affect 2 in every 10 people in their lifetime. Shingles is characterized by clusters of blisters, which develop on one side of the body and can cause severe pain that may last for weeks, months or years after the virus reappears.

    “This vaccine gives health care providers an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain,” said Jesse L. Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research.

    Zostavax, a live virus vaccine, was shown to boost immunity against varicella-zoster virus. This is thought to be the mechanism by which the vaccine protects against zoster and its complications. The vaccine is given as a single injection under the skin, preferably in the upper arm.

    Zostavax was studied in approximately 38,000 individuals throughout the United States who were 60 years of age and older. Of these 38,000 people, half received Zostavax and half received a placebo. All study participants were then followed for an average of three years to see if they developed shingles and, if they did, how long the pain lasted.

    At the conclusion of the study, researchers found that, overall, in those ages 60 and above the vaccine reduced the occurrence of shingles by about 50%. For individuals ages 60-69 it reduced occurrence by 64%.

    In addition to preventing approximately half of the cases, the duration of pain following the onset of shingles was slightly reduced in people who developed the disease–despite being vaccinated with Zostavax.

    The most common side effects in people who received Zostavax were redness, pain and tenderness, swelling at the site of injection, itching and headache. The percent of significant adverse events observed in the study were not different between persons who received the vaccine versus placebo.

    As part of the development program, a smaller study was conducted to look more closely at safety. In this smaller study, serious adverse events for all age groups were noted more frequently in those who received Zostavax (1.9%) than those who received placebo (1.3%). Although 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.
  2. kriskwon

    kriskwon New Member

    I was so excited -that is until I realized it was for 60 yrs or older. I asked my doctor if I could PLEASE get one. No Go. I'm the one who's had shingles over 30x. First time I wished that I was older - I'm 46.
  3. SandraJean

    SandraJean New Member

    I was surprised to see this on the news today, as today I just was dx with shingles. Never had it before and wasn't sure what it was.

    I've been taking care of my little 4 month old Grand daughter and am worried as it's contaigious.

    I just turned 60 this past year. I'll have to look into the shot after I get rid of shingles. Don't understand why it wouldn't be avaible for everyone!

    Sandy
  4. kriskwon

    kriskwon New Member

    As a matter of fact, shingles CAN be contagious. My husband never had Chicken Pox and after rubbing cream on my shingles a couple years ago, he did indeed get Chicken Pox from my Shingles. Doctor confirmed it.

    You CANNOT spread shingles as per say to another person though.

    If your granddaughter (? sorry, can't remember who you said you were babysitting) has not had the Pox, I would definetly stay away from her. You transmit them by direct contact.
  5. mme_curie68

    mme_curie68 New Member

    Your 4 year old granddaughter may have already been vacinated for chicken pox (varicella). I believe the first dose of the children's vaccine is given at 15 - 18 months.

    Have your son/daughter check her vaccination records - you may not need to be worried about transmitting your infection to her at all.

    Children are actually much better equipped immunologically to cope with Chicken Pox. After about the age of 14 and into adulthood, however, it can become VERY serious to contract.

    The downside to all of us who had it as kids is that the viral infection can reactivate from dormancy and give us shingles, which from all I've read and heard about are just horrible.

    I hope you feel better VERY soon.

    Hugs,
    Madame Curie



  6. kriskwon

    kriskwon New Member

    She said 4 MONTHS. I don't have any children, so I wouldn't know, do they get chicken pox this early?
  7. mme_curie68

    mme_curie68 New Member

    SandraJean -

    So sorry, I misread your post as 4 years rather than 4 months. Big difference.

    Check with your doctor and baby's pediatrician.

    Viral infections take root by hijacking the cells of your own immune system. Viral particles can be shed through coughs, sneezes, touch of the hand to eye or nose, body fluids, etc.

    Infants are very tough customers - when they get sick, their little bodies can compensate well for a good while, but when they decompensate everything goes to hell in a handbasket quickly.

    Generally, if an infant develops a fever younger than 6 months of age, they have to be hospitalized.

    Hugs,
    Madame Curie