New Supercharged Shingles Vaccine Has Serious Problems

New Supercharged Shingles Vaccine Has Serious Problems

Story Highlights

  • Shingrix, a new high antigen vaccine designed to prevent shingles (herpes zoster), is produced by GlaxoSmithKline and is being aggressively marketed for adults over age 50.
  • Approved for use in October 2017, the new vaccine is competing with Merck’s shingles vaccine, Zostavax, and there are already reports that Shingrix is associated with significant administrative errors and both common and severe side effects that may prevent people from returning for the recommended second shot.
  • Although not widely known, an increase in the incidence of shingles, particularly among younger people, was predicted and has occurred since the varicella zoster (chickenpox) vaccine was licensed in 1995 and subsequently mandated by states for children to attend school in the U.S.

The new herpes zoster (shingles) vaccine, Shingrix, is produced by GlaxoSmithKline (GSK) and is being marketed as the welcome and best answer to preventing a painful bout with shingles. GSK’s Shingrix vaccine is in head to head competition with Merck’s shingles vaccine, Zostavax, licensed in 2006. The relentless advertising for Shingrix is difficult to avoid: It is blared over grocery store speakers, has taken the place of muzak on pharmacy or doctors’ office hold lines, and is aggressively being promoted by nearly the entire medical establishment.

Shingles is caused by reactivation of the chickenpox virus (varicella zoster) in a person who has previously had either natural chickenpox or has received the vaccine. Children or adults who get shingles suffer with a painful, blistering rash, usually on one side of the body. The rash and blisters usually last for two or three weeks and the nerve pain may persist for months or even years.1 The condition usually occurs in adults over age 50, which is why public health officials and vaccine manufacturers target that population for marketing shingles vaccines. However, shingles has also been diagnosed more frequently in children since the chickenpox vaccine was licensed and recommended for all healthy children in 1995.2

Two doses of Shingrix costs close to $300.

Since its approval in October of 2017, Shingrix vaccine has overshadowed the older Zostavax vaccine produced by Merck, which had been the only shingles vaccine available in the U.S. for more than a decade. Shingrix is reported to be up to 90 percent effective in preventing the development of shingles, compared to an estimated 50 percent effectiveness for Zostavax.3

Administrative Errors

Even among the vaccine’s most ardent supporters, however, the news about Shingrix hasn’t all been positive. In June, the Centers for Disease Control and Prevention (CDC) published a report discussing a significant number of administrative errors and serious injuries associated with the new shingles vaccine.4 Within the first four months of being on the market, the Vaccine Adverse Event Reporting System (VAERS) received 155 adverse event reports linked to Shingrix.

Several of the errors were attributable to vaccine administrators confusing the two shingles vaccines, which actually differ in significant ways. Merck’s Zostavax is a live attenuated vaccine (ZVL) that is given once as a single shallow injection, just under the skin (subcutaneous injection). GlaxoSmithKline’s Shingrix is a recombinant vaccine (RZV) that must be reconstituted prior to injection and is administered deeper into the muscle (intramuscular injection). Shingrix is given twice, with the second dose given between two and six months after the first one.

The reported errors associated with Shingrix included administration via the subcutaneous route, a mistake that usually caused significant injection site reactions including pain, severe itching (pruritis), and redness (erythema). Other errors reported were administering the vaccine to patients younger than 50, giving out the wrong vaccine information sheet (VIS), administering just the vaccine’s novel adjuvant without reconstituting it with the actual vaccine antigen, and mistakenly giving the shingles vaccine to a person who was supposed to get chickenpox (varicella zoster) vaccine.

New Adjuvant Turbocharges Immune Response

One of the challenges for manufacturers of inactivated vaccines like Shingrix is that they do not contain a live-virus, which traditionally have provoked stronger immune system responses. The strong immune system response reported for Shingrix is due to one of the new vaccine’s ingredients, QS-21 Stimulon manufactured by Agenus, Inc.

The novel vaccine adjuvant QS-21 Stimulon is a purified extract from the bark of the Quillaja saponaria vergreen, otherwise known as the soap bark tree.5 QS-21 Stimulon is an “immune potent” adjuvant designed to “turbocharge vaccines by strengthening and broadening immune responses (both T cell and antibody mediated) to a vaccine’s antigens.” The new adjuvant is currently under study for use in immune therapies against cancer, HIV, and malaria.6

Shingrix vaccine’s novel adjuvant system, AS01B, not only contains QS-21 Stimulon but also MPL (monophosphyoryl lipid a), an immune-stimulating fat. Shingrix ingredients (per dose) include 50 mcg of the QS-21 and 50 mcg of 3-O-desacyl-4’- monophosphoryl lipid A (MPL) from Salmonella minnesota, as well as 50 mcg of its antigen: recombinant glycoprotein E (gE), along with 20 mg of sucrose (as stabilizer), 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.7

Severe Side Effects

Even when it is administered according to protocol, the Shingrix vaccine is very reactive. The vaccine’s side effects are known to be more severe than those associated with Zostavax, but public health officials insist the vaccine’s benefits are worth the risk of “skin rash, joint pain, flu-like symptoms, headaches and fatigue” commonly experienced by those who get it.8 Kathleen Dooling, MD of the CDC’s Division of Viral Diseases admitted that more than 70 percent of patients had pain and, “About one in six people experienced side effects so severe that it actually prevented their normal activities.”

In fact, the side effects of Shingrix are so severe that the vaccine’s promoters are concerned that many people will not be willing to go back for the second dose of the vaccine.

Early Warnings of Shingles Epidemic

After participating in a CDC funded study of the effect of widespread use of chickenpox vaccine in California between 1995 and 2002, researcher Gary Goldman, PhD, published a major paper in 2005 warning that the decline in incidence of chickenpox would lead to an increase in children developing shingles.9

In 2003, Goldman predicted that “a large-scale increase in shingles incidence would soon become manifest among adults—a group more susceptible to serious complications.”10

Referring to the “solution” proposed by vaccine manufacturers at the time—to license a booster “shingles” vaccine to substitute for the natural boost in immunity that occurred when people were exposed to wild-type chickenpox in the environment—Goldman said, “This will likely lead to endless disease-and-cure cycles.” 

Questions Remain About the Rising Incidence of Shingles

The incidence of shingles is much higher than it used to be, and it is being seen in younger people, though there is disagreement about the reasons for the increase. Many scientists have suggested that mass vaccination of children with the varicella zoster (chickenpox) vaccine has reduced the presence of the chickenpox virus in the environment, thereby eliminating the natural immune system boost people used to get from exposure to the virus.12 At one point it was thought to provide 20 years of protection, though more current thinking puts the effect at more like two years.12

The current mainstream medical message denies that the chickenpox vaccine is responsible for the observed increase in shingles,13 but others suggest that the knowledge has been deliberately suppressed.14

Clarification: In response to a comment by one of our readers, the word “muzak” in the first paragraph of this article is not misspelled. It was not meant to be “music,” but rather a reference to the background music often played in retail stores, elevators and other public locations.


References:

1 Shingles: Overview. American Academy of Dermatology 2018.
2 National Vaccine Information Center. NVIC Challenges VAERS Data of Chickenpox Vaccine Adverse Events. Press Release Sept. 13, 2000.
3 Esposito L. A New Shingles Vaccine: Prepare for Harsher Side Effects. U.S. News & World Report June 15, 2018.
4 Centers for Disease Control and Prevention. Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine — United States, 2017–2018. CDC.gov May 25, 2018.
5 Adjuvants: QS-21 Stimulon®. Agenus. C 2018.
6 Ragupathi G, Gardner JR et al. Natural synthetic saponin adjuvant QS-21 for vaccines against cancer. Expert Rev Vaccines 201; 10(4).
7 Package insert.  GlaxoSmithKline Biologicals. C 2017.
8 See Footnote 3.
9 Raines K, Fisher BL. CDC Accused of Manipulating Shingles Data. The Vaccine Reaction Aug. 19, 2018
10 Threat of Shingles Epidemic from Chickenpox Vaccine. Vaccine Choice Canada Oct. 1, 2003.
11 Raines K. Chickenpox Vaccine May Increase Shingles Risk. The Vaccine Reaction Apr. 26, 2016.
12 Chickenpox Vaccination Does Increase Shingles Cases, but Mainly in Young Adults. Science Daily Aug. 11, 2015.
13 Gordon S. Chickenpox Vaccine Not Responsible for Rise in Shingles, Study Says. WebMD Dec. 2, 2013.
14 Goldman GS. The US Universal Varicella Vaccination Program: CDC Censorship of Adverse Public Health Consequences. Annals of Clinical Pathology Mar. 31, 2018.

31 Responses to "New Supercharged Shingles Vaccine Has Serious Problems"

  1. MaryAnn MxDowell-Miller   September 6, 2018 at 5:21 pm

    The VA doctor in Oklahoma talked my husband in taking the Shingles shot over two years ago. Shortly after taking the shingles shot he started experiencing incontinence. He had never had that problem before. The immediately put him on Flomax for the incontinence. The Flomax made him so confused he was trying to drive on the wrong side of the road. He went to put the electric controlled hatch down on our van and did not step back far enough and the corner of the hatch door hit him right across the eyebrow and knocked him out. He stumbled around, turned toward the street and fell face forward down the drive way. He spent two nights in the hospital for observation as he has four areas of blood bleeding in his brain. With that short stay he acquired hospital induced pneumonia and the next weekend spend three nights in the VA hospital for that.

    Reply
    • Karen   September 6, 2018 at 9:14 pm

      Wow, thanks for sharing. Many people have no idea of the immediate or delayed symptoms or medical conditions they may develop later on from the vaccine. People need to be educated.

      Reply
    • Cindy   September 6, 2018 at 9:16 pm

      Oh my gosh how horrible! I’m so sorry to hear that ;(

      Reply
  2. sheldon101   September 6, 2018 at 7:01 pm

    If you want a more effective vaccine, you sometimes have to have a vaccine that will cause more temporary side-effects. I believe the DTP vaccine had one of components a killed whole virus. Because of the side-effects which created much of the anti-vaxxer infrastructure, they went to a vaccine that used just parts of the virus. The vaccine is safer in terms of temporary side-effects but not as effective in terms of efficacy.

    This is seen with flu vaccines where higher dose vaccines are especially used for the elderly, who have a weaker immune response.

    No surprise that the new shingles vaccines will have more temporary side-effects.

    Reply
    • Jean   September 15, 2018 at 1:06 pm

      No, I don’t want a more effective vaccine. I want to keep my immunity strong by eating organic, sleeping 8 hours a night, exercise, relaxation with music or meditation. And NO Vaccine. No adjuncts of mercury or aluminum that might end up in my brain causing dementia. No thank you.

      Reply
    • Kat_Lyb   September 18, 2018 at 11:48 pm

      I don’t believe that the incontinence a woman commented as a side effect experienced by her husband after having received the vaccine is temporary. I’m curious as to what your comment might be regarding the increase of shingles outbreaks since the introduction of the chicken pox vaccine and it’s having heavily removed the chicken pox virus from the population being the cause of this increase?

      Reply
  3. Mary   September 6, 2018 at 8:02 pm

    I am just getting over a case of the shingles so would there be any sense in getting the vaccine in the near future?

    Reply
    • Kathy   October 6, 2018 at 10:02 pm

      They say you should still get Vaccine. I would check with Dr on when to do. I had them when I was 37 and now I’ll be 54. The Drnts me to wait untilm60 to get.

      Reply
  4. Jan   September 6, 2018 at 11:38 pm

    People need to learn how to cure their shingles if they should experience it. For starters, do what the Austrians and German doctors do……high dose vitamin C, as a lipospheric vit c, and high dose B vitamins.

    Reply
  5. bar45   September 7, 2018 at 1:21 am

    sheldon101, the higher dose flu vaccine that is given to the elderly has never been shown to decrease the incidence or severity of the flu. It was approved solely based on an increase in antibody level in those who received it. So the elderly are being used as guinea pigs.

    Reply
  6. Kathy   September 7, 2018 at 8:54 am

    When will people understand that when you mess with God’s creation and the normal perfectly capable immine system of healthy people, especially out of greed, you will get burned. You can’t perfect perfection.

    Reply
  7. Mary   September 7, 2018 at 9:13 am

    VACCINATION IS NOT IMMUNIZATION!! People please wake up. Big Pharma uses you as their guinea pig. They enlist the help of the FDA, CDC and our Congressmen to make sure by law that infants, toddlers, children, young adults get a schedule of 69-74 vaccinations with the most being given as a child.

    Now they are targeting older adults and the elder with their toxic poisons. You need to research and educate yourselves about vaccines. They are dangerous and deadly. Why would you allow a poison to be injected into your healthy or half healthy body to cause health issues?

    Vaccines are nothing more than a money maker for Big Pharma, doctors, Congressmen, the pushers at the FDA and the CDC. They are ALL complicit in having the pockets lined from Big Pharma.

    Why are so many children sick and dying from “rare” cancers and tumors, have neurological issues, muscle issues, auto-immune issues? The single thread running through all these diseases and “rare” cancers is the vaccines that are loaded with mercury, aluminum, fetal tissue, bovine proteins, etc., just to name a few.

    Go to YouTube and WATCH the series on “The Truth About Vaccines.”

    Reply
  8. j   September 7, 2018 at 2:01 pm

    as with any skull lobotomy, a “temporary side-effect” is great, unless YOU or YOURS are the one(s) that’s injured die, etc.
    Trust your docs & esp. the medical administration who took an oath,
    First Do Big Profit.

    One Less.

    Reply
  9. Jenna   September 7, 2018 at 6:34 pm

    My theory for the increase in shingles is this.
    Wild chickenpox is becoming less common, and so people are not being exposed throughout their lives, and therefore boosting their antibodies naturally. So, when their health begins to decline in old age and the zoster is reactivated, there are not enough antibodies to fight it. Deleting the chicken pox (if you even believe THAT vaccine works) just made shingles a whole lot more common for EVERYONE. Or maybe they’ll just keep suggesting more and more boosters and our population decreases to the point of extinction…

    Reply
    • Kat_Lyb   September 18, 2018 at 11:50 pm

      Yes, the article mentions this and I firmly believe this theory is 100% accurate.

      Reply
  10. Kirk   September 8, 2018 at 9:31 am

    I got the new Shingrix and happy I did !! I had chickenpox at 30ish and shingles at 59. My wife is just getting over shingles. Trust me … you don’t want shingles! Get vaccinated and wear your bandaid proudly.

    Reply
  11. drbhelthi   September 9, 2018 at 11:32 am

    There is no evidence established by the scientific method that indicates vaccines do what they are alleged to do. NONE.
    Vaccination is based on a “belief”, that was introduced by Edward Jenner of England, about 1790, and proclaimed by his following, who were interested in profitting. Several Jenner family members died from his experimentation, and the Dr. title was awarded as an “honor” rather than earned via formal study.
    Perhaps the highest scientific authority saying vaccines are contaminated is professor Garth Nicolson, cell biologist and editor of the Journal of Clinical and Experiental Metastasis and the Journal of Cellular Biochemistry. Professor Nicholson is one of the most cited scientists in the world, having published over 600 medical and scientific peer-reviewed papers, edited 14 books, and served on the editorial boards of 28 medical and scientific journals.
    Scientist Nicholson states that not only are vaccines contaminated with mycoplasma but warns the US that we are all being damaged by them and contracting chronic, degenerative diseases.
    His videos are at_ https://www.youtube.com/watch?v=6WIWwEtjDRk

    Reply
  12. redpill   September 19, 2018 at 10:42 pm

    My uncle developed shingles 3 days after he was given the shingle vaccine. This was 5 years ago when he was 83. I warned him not to get it but his Doctor convinced him it was needed. He suffered terribly with that virus and it finally abated 5 months after it developed. However, fighting the infection his health deteriorated. For the next 5 years he was in and out of the hospital and spent the last 2 years in a care facility rather than his home because he needed more attention than my aunt could provide. He died last week and from the time he took that shot he continued to have nerve pain. Is there a connection between his deteriorating health and the Shingles vaccine? I think so.

    Reply
    • Jeannie Wade   October 2, 2018 at 4:28 pm

      I am not a scientist but I think it highly unlikely that the shot was related to his bout with shingles. It takes longer than 3 days for the virus to take hold. Most likely your uncle had the onset of shingles prior to his injection.
      It is quite possible that if he had declined the injection – and 3 days later developed shingles, he would have regretted not having the injection much earlier.
      All this is impossible to prove but something to ponder.

      Reply
  13. Maxine   September 23, 2018 at 8:45 pm

    My daughter-in-law recently suffered greatly for many weeks from shingles in her ear and tongue. I took the first Shingrix dose and had some ill feelings for a few hours and a very sore arm for several days. Definitely way better than having shingles. People need to stop this nonsense about the danger of vaccines. They forget that many people died from smallpox, or were paralyzed and in an iron lung with polio, or even died from flu before vacccines were developed.

    Reply
  14. Karen Kordisch   September 27, 2018 at 1:44 pm

    I got shingles 2 days after I had the first Shingrix shot. I had never had shingles before. I reported this to the CDC and the manufacturer who both suggested it was “a coincidence.” I also reported it to VAERS. I have chronic lymphocytic leukemia (CLL), stage 0, so I am only able to take the “dead” vaccine. I don’t think this one is “dead” enough.

    Reply
  15. Jamie   October 11, 2018 at 6:42 pm

    Both my shingles vaccines have made me very sick with flu-like symptoms, fever and a very achy body. I’m one of the “lucky” 6% who gets this reaction. Tylenol takes care of it, but it’s a pain to be sick for 3 or 4 days after the injection. You feel horrible! However, having had shingles, I’d take these few days of really bad discomfort to having actual shingles any day. I had them in my mid-50’s and it was awful. I cannot imagine how bad it would be at age 70.

    Reply
  16. MARTIN WOLFF   October 11, 2018 at 8:39 pm

    Shingrixed and still kicking.
    I had my first Shingrix shot on 8-1-18, and my second one on 10-7-18. My side effects for both shots was a sore upper arm/shoulder at the site of the injection which lasted for two-to three days, That’s it, nothing else. At 75, and from what I’ve heard about shingles, I’m glad I had the shots. FYI: I heard on that medical news show from a promenant NY hospital discussing this issue, the second Shingrix shot is more effective if given right after a two month wait, rather than waiting any longer, so I acted quickly for my second shot. Hope this gives you the confidence you may need if you’re on the fence. Good luck!!! By the way, my pharmacy, in Prividence, RI, charged me $160 for my second shot. The first shot was $140.

    Reply
  17. Ellen   October 29, 2018 at 12:36 am

    Jamie, I went through some of the same symptoms in August and then just a few days ago after the second dose. But it’s very preferable to having shingles. A friend of mine has suffered horribly from that disease. She was literally screaming in pain. Another friend’s brother almost went blind from shingles. I could go on but the point has been made. There are risks from vaccines just as there are risks from any other treatment but I am willing to take those risks.

    Reply
  18. Trisha   November 10, 2018 at 8:51 pm

    I have Rheumatoid arthritis, for which I take orencia infusions monthly.
    My rheumatologist says I should get Shingrix vaccine in between my infusions, which lower T cell activity in my immune system.
    Has anyone taken orencia and Shingrix
    alternately? I am 66.
    ?

    Reply
  19. Kathy   November 13, 2018 at 11:26 am

    I have had a terrible reaction to the second shingles shot a month ago. My right leg burns, tingles and is so painful. I got the typical flu like feelings with headache and head pressure soon after the shot but developed a rash and pain, itching and burning in my leg about 5-7 days after the shot. My doctor said that some people are suffering for up to 6 weeks after the shot so I hope I don’t have shingles and that this will go away soon. Very uncomfortable. Almost went to the ER. I Reported it to CDC FDA GlaxoSmithKline. Doctor and pharmacy didn’t report my reaction. The FDA said they have a hard time getting docs to report.

    Reply
  20. Charlie   November 15, 2018 at 1:03 pm

    I received my Shingrix vaccine on 9/14/18 and my arm hurt for almost 2 weeks. And by hurt, I mean I could barely use my arm for 2 weeks. I then noticed my ears ringing. I am now on a very strong dose of prednisone while waiting to get my hearing checked and to see an ENT. I have lost a good portion of my hearing in my right ear. I was given the vaccine in my right arm. I will never go to get the second vaccine.

    Reply
  21. Marvin   November 15, 2018 at 7:02 pm

    Vaccines are dangerous. Someone spoke of polio—Im 64 and had polio at age 5 So everyone thinks polio is gone? What few realize is that hundreds of thousands of folks had polio and didn’t know it. The problems started much later in life with ‘Post Polio Syndrome” and that’s IF the problems are recognized by a specialist.

    Vaccines are now thought to be the cause of the HUGE increase in autism. They cause brain inflammation.

    Regarding this shingles vaccine—someone above is correct—there is ZERO PROOF that it works. How could they prove it? Think about it. WE are all sheep being herded down the money shuts. You know that vaccinations are a 60 BILLION dollar industry???? My father in law didn’t have signs. He got the vaccine and several weeks later had shingles that did NOT GO AWAY for his final two years of life. Coincidense? He was just about to get them anyway? I had chickenpox as a kid. I am afraid of shingles but no way will I do this vaccination.

    Reply
  22. GoodWill   November 17, 2018 at 5:22 pm

    Got the Shingrix vaccine basically because a popular sports figure was used to advertise. Had no problem with the first dose. But after the second dose began to feel the above mentioned, joint pain, flu-like symptoms, headaches and fatigue.” Mild, but noticeable. That’s why I’m reading the article. It’s true we can’t “prove” the vaccines work because as humans we can’t know the future as to whether we get Shigles or not. I’m just trying to stay in the mainstream, and stay as healthy as possible, by taking advice from people who we trust.

    Reply

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