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SHINGREX, New Vaccine Approved by FDA for Shingles!

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Merry19451
Merry19451

To All Shingles and potential Shingles sufferers!

News > Medscape Medical FDA Approvals

FDA Clears Shingles Vaccine Shingrix for Adults 50 and Older

October 23, 2017

GlaxoSmithKline's recombinant zoster vaccine (adjuvanted) (Shingrix) has been approved in the United States for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

The approval follows a unanimous vote last month by the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (FDA) that the vaccine is effective and safe for adults aged 50 years and older.

Shingrix combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age, the company explained in a news release. Shingrix is given in two doses, with a 2- to 6-month interval between doses.

"Shingrix represents a significant scientific advancement in the field of vaccinology," Thomas Breuer, MD, senior vice president and chief medical officer, GSK Vaccines, said in the release. "The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity," he said.

The approval of Shingrix was based on a phase 3 clinical trial program that evaluated the drug's efficacy, safety, and immunogenicity in more than 38,000 people. In a pooled analysis of these studies, the vaccine demonstrated efficacy against herpes zoster of greater than 90% in adults aged 50 and older and in those aged 70 and older. Efficacy was sustained during the 4-year follow-up period.

The most common side effects reported in the clinical trials were pain, redness, and swelling at the injection site. Most reactions were transient and were mild to moderate in intensity, lasting fewer than 3 days.

According to the company, the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at a meeting scheduled for October 25, the company said. "Following this approval from FDA, and pending a recommendation from ACIP, Shingrix will be available shortly," the company said.

Shingrix was approved in Canada earlier this month for the prevention of herpes zoster in people aged 50 years or older. Regulatory filings in the European Union, Australia, and Japan are underway.

4 likes, 14 replies

14 Replies

  • babs99203
    babs99203 Merry19451

    Posted

    Well I believe that's good news. But personally, I'm always leery of new breakthroughs like this. I'll wait until a few million other people try it first. I had a Guillian Barre-type reaction to a flu shot about 10 years ago and can't have one now. I'm sure others will be more eager than I and will welcome the news and opportunity.

  • valerie03145
    valerie03145 Merry19451

    Posted

    I have been watching for this news and am so excited!   Merry, I especially hope it will be the end of this long ordeal for you.   Do you know if approval for age 50 and over means a person MUST be over 50 to get it, or will a doctor have the right to provide it to younger people with a history of recurring shingles outbreaks?   I'm currently taking 500 mg Valtrex per day for suppression.  Do you know if I need to stop taking it a certain amount of time before getting the new vaccine?    Thanks for sharing this news!

    • Merry19451
      Merry19451 valerie03145

      Posted

      Hi Valerie,

      I don't know any of the details, as yet, unfortunately. You know the horrific game of insurance companies. They might get smart and figure an ounce of prevention is worth a pound of cure.

      I am unaware of the need to stopping the antiviral before getting Shringrix.

      Best Wishes to you.

      Merry Juliana

  • Elsabe13
    Elsabe13 Merry19451

    Posted

    Thanks for letting us know Merry 🤗Hope you're feeling better - we really appreciate you 💐

  • beth97678
    beth97678 Merry19451

    Posted

    Wonderful news Merry.I'm thinking you might be cautiously optimistic that this vaccine might at last be the one which will stop your recurrent bouts with this 'orrible virus.I really do hope so.X

     

    • Merry19451
      Merry19451 beth97678

      Posted

      Thank you, Beth! Since I have followed the high Lysine low Arginine diet, the frequency of episodes of Herpes Zoster-Shingles has decreased markedly! It may also be related to the partial mastectomy and radiation therapy ie the breast cancer and radiation can trigger Herpes Zoster-Shingles, but with tincture of time, less stress, and the diet, I am much better.

      Best Wishes

      Merry Juliana

  • Adldiane
    Adldiane Merry19451

    Posted

    Merry are you Merry Juliana that I have spoken to about shingles on other occasions? I am so excited about the new vaccination coming out and am wondering how you feel about it. Your friend. Diane. 
    • Merry19451
      Merry19451 Adldiane

      Posted

      Hi Diane!

      First,

      I hope you are doing better.

      The Shingrex vaccine manufactured from a killed virus, rendering it safer for all who take it. It contains an adjuvant that boosts its efficacy to 93%, that does not want over time.

      The Zostavax is a live vaccine. The efficacy rate is 53-37%, a dismal rate. The older one is, the less effective it is.

      I do not know if one has had recurrent Herpes Zoster-Shingles, if Shingrex will be effective in reducing or eliminating the disease.

      I plan on getting the vaccine once it is offered, however.

      I do consume a High Lysine Low Arginine Diet. I also had an exceptionally low Vitamin D level and take Vitamin

      D3 2000 IU daily. I believe both the High Lysine diet and Vitamin D3 have contributed to markedly decreased episodes of Herpes Zoster-Shingles. Vitamin D3 is necessary for a healthy immune response.

      Merry Christmas

      Merry Juliana

  • Adldiane
    Adldiane Merry19451

    Posted

    Hello again. Yes thank you I am at least fighting off shingles with the meds and I too plan to take the new vaccine as soon as it becomes available. 

    I have been wondering if you would take it. I'm so hopeful that it will help you in particular because you have suffered the longest. 

    Thank you for all the information on the new vaccine. 

    God bless and Merry Christmas. 

    Diane

    • Merry19451
      Merry19451 Adldiane

      Posted

      The message should have said "wane"over time.

      Merry Juliana

    • Merry19451
      Merry19451 Adldiane

      Posted

      My smart phone thinks it spells better than I do! LOL

      MERRY JULIANA

    • Adldiane
      Adldiane Merry19451

      Posted

      So does mine. And sometimes it does. At other times it torments mesmile! 

      Diane

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