Shingrix vaccine for Shingles

A few weeks ago I saw my primary care doctor to get annual checkup / renewal of Hema insurance referral. He wants me to inquire with my Hema about getting the latest Shingles vaccine called 'Shingrix'. It was just approved by the FDA in Oct of last year, 2017. I've never heard of it before.

So, began a little research effort. Here is the approval information by the manufacture, GSK.
ca.gsk.com/media/1350788/shingrix_pm-2017-10-13.pdf
Here is the CDC information on the earlier 'live virus' vaccine for shingles which is called Zostavax.
www.cdc.gov/vaccines/vpd/shingles/public/zostavax/index.html
Here is the CDC information on Shingrix.
www.cdc.gov/vaccines/vpd/shingles/public/shingrix/index.html
If you compare the two CDC pages, notice that Shingrix can be given to those who have 'weakened immune system' (eg taking steroids), which is a restriction for Zostavax.

Ok, if I'm understanding correctly, Shingrix is a 'biologic'. It is genetically engineered from Hamster ovary cells, see page 14 of the GSK info. They use the term 'recombinant' instead of 'biologic' it seems. Because it is genetically engineered, it appears as though it has been designed to specifically not give one Shingles from the vaccine. Hence Shingles is not listed as an adverse event for Shingrix.

My thinking is that this vaccine is safe for me, and safe even for anyone with ITP in general. Thoughts?

I'm sure you don't want to hear from me. :laugh: First, since it's so new, there is very little post-marketing experience with this vaccine making this the season of vaccine guinea pigs. I just read an article about a new vaccine for Hep B. It was declined by the FDA twice due to concerns about an increased incidence of heart attacks and autoimmune disorders after vaccination, but the third time they approved it despite the warnings. "Heplisav-B differs from other licensed hepatitis B vaccines in that it contains a new synthetic adjuvant known as cytosine phosphoguanine 1018 (CpG 1018) composed of short synthetic DNA molecules." No thank you.

thevaccinereaction.org/2018/08/fda-licenses-new-hepatitis-b-vaccine-despite-big-safety-concerns/

Because of my known reaction to rodent cells, I won't be going near Shingrix. I saw a doctor on FB say that about 40% of his patients who got the Shingrix vaccine ended up with shingles. I don't know how true that is.

That is a tough call Hal. Trust me you don't want to get shingles-I had it 2 years ago and the nerve pain lasted 6 months. I am glad they have a vaccine that does not contain live virus now. But, like Sandi said, it is new and since you have ITP you might want to hold off and let other people with normal immune systems be the guinea pigs first. You should talk to your hematologist and see what he recommends.

I've had shingles too. It hit the nerve in my arm and affected the muscle in my left hand. I couldn't use my hand for almost six months and had to go to PT.

Just an FYI - you can contract shingles by being exposed to someone recently vaccinated for chickenpox. 'Tis the season with all of the back to school vaccines going on. I will be staying away from my grandson when he gets his, and that will be very hard!

5.8
Risk of Vaccine Virus Transmission
Post -licensing experience with VARIVAX suggests that transmission of varicella vaccine virus may occur between
healthy vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella, as well as high
-risk individuals susceptible to varicella. High-risk individuals susceptible to varicella include:

Immunocompromised individuals; Pregnant women without documented positive history of varicella (chickenpox)
or laboratory evidence of prior infection; Newborn infants of mothers without documented positive history
of varicella or laboratory evidence of prior infection and all newborn infants born at <28 weeks gestation regardless
of maternal varicella immunity.
Vaccine recipients should attempt to avoid, to the extent possible, close association with high-risk individuals
susceptible to varicella for up to 6 weeks following vaccination. In circumstances where contact with high-risk
individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus
should be weighed against the risk of acquiring and transmitting wild-type varicella virus.
www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi.pdf

www.webmd.com/skin-problems-and-treatments/shingles/news/20180212/new-shingles-vaccine_what-you-need-to-know
I don't usually go to webmd but...
I don't have to think about it as I'm sure my HMO doesn't cover this new one. However I was recently sent to an immunologist because of low IgG - we discussed immunizations since my ITP was triggered by a gamma globulin injection. Titers for the tetanus booster given in the summer of 2002 came back still effective - won't go into the others but I did ask him if I were to need everything that was tested which should I get first and the answer was the shingle vaccine [since I've never had that vaccine I don't even know if there is a titer test].

I will say I have had shingles 2x and I really do not care to have it again!! My friend got shingles in Jun of 2017 and still has the nerve pain over a year later, not as bad but she has it. Know a man who got shingles and he was "blessed" with postherpetic neuralgia and nothing helped his pain, he had it until the day he died many years later. Don't let anyone poo-pah shingles. It comes down to you have to do what you feel is best for you. I would be more inclined to listen to my doctor than a doctor on facebook. I do not know anyone who has had this new vaccine but I know plenty who have had the old one and none had any problems with it.

Like you I am debating what to do - get the old one or look into the new one, to get or not to get that is the question. But like I said, I do NOT want to ever have shingles again.

According to Consumer Reports, "Right now, Shingrix is not recommended for older adults who are immunocompromised or are taking moderate to high doses of drugs that suppress the immune system." This may change as more information becomes available.
www.consumerreports.org/shingles-vaccine/new-shingles-vaccine-shingrix-what-you-should-know/

I'm a big fan of vaccines and their direct role in how quality of life and longevity have improved around the world.
However, this is a new one and I'd wait to see some data outside of the mandatory pre-market studies.

I didn't think it was that long Sandi, 6 weeks, to avoid someone who has the chickenpox vaccination. I didn't do that - didn't even know when The Grands got that vaccination and since see them weekly I must have been with them during that 6 weeks. But then I am not immune suppressed then or at the moment. Know you will miss the little guy [I was surprised to see he was getting a vaccine].

I will definitely miss him! I can't go a week without seeing him now. He just started crawling and sitting up this week. But since I've been on Prednisone since 2006, I don't want to chance it. I'm not worried about the other vaccines that shed, just this one.

Sandi - I thought that exposure to someone who had varicella vaccine put you at risk for chicken pox if you were immunocompromised - I guess then indirectly shingles as opposed to a direct link. I think you are wise to keep your distance since it is live virus.
My daughter continues to be in remission after taking Promacta and is doing well however she had shingles the end of July into August (she had chicken pox at 3). I don't know if it is her quirky immune or just chance, but the only people that young I have seen with shingles have had underlying immunocompromising issues. Her case was not terrible and thankfully the nerve pain subsided in about 2 weeks. But I have been looking at the Shingrix for my mother because with all her nerve pain and ortho issues shingles would be horrible for her, so I will follow this with interest.

I've heard from both my gp and my pharmacist that the old one isn't as effective as the new one. The old one only works about 20%. I think when the time comes, I will be going with the new one. It's just a wee tad expensive for us right now.

Terri - I've already had chicken pox naturally, so exposure to the zoster virus after chicken pox usually results in shingles due to reactivation of the virus.

Unless things have changed, they don't use the varicella vaccine in the UK. They are wise. It seems that the incidence of shingles is going up due to the vaccine. Chicken pox is such a normal childhood disease!

www.ncbi.nlm.nih.gov/pmc/articles/PMC2563790/
www.nhs.uk/conditions/vaccinations/chickenpox-vaccine-questions-answers/#routineschedule

Thank you for the articles - you answered a few questions I did not research yet!
I work in an area with a lot of global migration. Many of the Central/ South American countries and the Caribbean countries also do not immunize against chicken pox.
When the vaccine was first becoming mainstream I was at a conference where the infectious disease specialist call it a productivity vaccine - it prevented the parents from missing large amount of time from work. My kids 23 and 21 are probably the last set to have chicken pox naturally before the vaccine became widespread and mandatory.

You're absolutely right. Varicella vaccine was created for 'mommy convenience' (and profit).

My three kids had chicken pox literally a week before the vaccine became available in 1995 (per our Ped). Yes it was very inconvenient because of my job, but we got through it and I'm grateful that it happened that way. They are better off.

Sandi, would you know?
They talk about Shingrix being derived by Hamster ovary cells on page 14 of the GSK info. Is doing this sort of thing new with vaccines these days?

This seems to be a very special form of 'dead' virus. LOL, it's beyond dead. It's genetically engineered dead.

Hal, that's fascinating about the hamster cells! I just had to look it up and came across this (half of which I don't understand): www.bmj.com/content/360/bmj.k1378/rr-10

Hal:

They have been using animal cells for years to manufacture vaccines. First was monkey, then they began using chicken, bovine, pig, canine, and most recently, hamster and caterpillar. They also use aborted fetal tissue.

This new 'biologic' vaccine language scares me. New synthetic adjuvants are being used. I don't even think the old adjuvants are safe. You can't inject animal and insect cells into humans without repercussions and I think we are seeing that with all of the autoimmune disorders. The first polio vaccine was contaminated with a monkey virus (SV-40) which is well documented. Millions of children (including me) had those vaccines. You can't even give people to people cell transfers without the possibility of rejection. To think that we can inject animal and insect cells without a problem is ludicrous.

Having had first hand experience with a biologic, I think they are dangerous. They might be handy to use when life is at stake, but for prevention, not worth it.

What have you decided, Hal?

I did my homework on the original shingles vaccine. It only worked at prevention 25% of the time, and that was only in people near 50 years of age. That small benefit wore off by age 65, and severity of the disease has never been proven to be lower with use of the vaccine. Wasn't worth the risks to me. As for the new version, it's far too new for me to buy the sales pitch. Don't care how many MDs are touting it. They don't investigate this stuff scientifically, and they're as susceptible to slick sales pitches as the average Joe.

I'm still reeling from my Rituxan experience, so maybe I'm even more sour on the subject of risk than usual. But I'll share what happened at my last hema visit 3 weeks ago. I was once again bemoaning the fact I took that vile stuff. I know I should let it go, but all the residual damage I'm dealing with won't let me yet. My hema has never been a touchy-feely kind of guy. In the 10 years I've known him, he hasn't shared one whit about his life. At this visit - maybe just to get me to quit whining - he started telling me about an experience he had as a kid. In 1955, just 2 weeks after the Salk vaccine was introduced, he got a shot of the first release of the supposedly "attenuated" live virus vaccine. Turns out it wasn't attenuated. He contracted polio, as did a multitude of other kids. He walks with a pronounced limp to this day. I think his point was that "stuff happens" and we have to move on. But I'm still not ready.

Janet - you are referring to "The Cutter Incident". Salk's vaccine was a huge flop, but that's not what they teach in schools. Salk supposedly saved the world from polio when in fact, he caused many cases of it and some children died. When you research polio, you find that after the vaccine, they changed the way polio was diagnosed and defined, and it's been renamed 'accute flaccid paralysis'. So yes, 'polio' disappeared but the actual illness has not. 'Accute flaccid paralysis' is a listed side effect on some of the vaccines. Guillain Barre is awfully similar too. Both Salk's and Sabin's vaccine were contaminated with the SV-40 (monkey virus) which is known to cause cancer and autoimmune disorders. They knew it, but continued to give it to millions of children from 1955 to 1963. This is only the tip of the iceberg about vaccines. We are misled in so many ways!

About moving on....it's not that easy. I'm also angry about what happened to me. I made the decision to put it into my body though so I blame myself. I've become much more careful about everything now so as horrible as it was, it was a learning experience. I didn't take the side effects seriously enough but boy I do now! I read everything, especially vaccine inserts and there are horrible side effects listed, including death. Everyone thinks side effects are so rare but after researching for four years, that is far from the truth.

Well Janet, I've still got a few more weeks to decide. Still working on it. A few loose ends to cover so far.

Sandi, I think some people get a rash around the injection site and call that getting Shingles from the vaccine. Still, it is troubling to me that one in six have a 'strong' reaction to the vaccine. The adjuvant must be very, very inflammatory to invoke such a long lasting immune response and in such a large percentage of the population.

Maria, that was an interesting link to The BMJ. I don't recall having been to that site before but it looked like a good one. Do you have membership access to all its data? As for Mr Arumugham's comment, it looks like he made a logical error. He described issues with derivatives grown from yeast with the HEPLISAV-B vaccine, but then extended the idea to Shingrix. The problem with that is Shingrix is not developed from yeast. It's from Hamster cells.
Somewhere in there I got this link:
"FDA Briefing Document SHINGRIX"
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM575190.pdf
This is very detailed information and I want to look at it some more. Why both of these vaccines have 1) supraventricular tachycardia and 2) tachyarrhythmia issues needs at least a theory of due diligence. Note that these two adverse events occur in the first two months ONLY, NOT LATER. Sounds a bit like a transient/temporary immune response issue only. I'm wondering if the strong adjuvant reaction, not the virus, is what is in common.

And then there was the other link to a Consumer Reports article.
www.consumerreports.org/shingles-vaccine/new-shingles-vaccine-shingrix-what-you-should-know/
What I found most valuable there was the individual user posts/comments below the article. Here are some of those posts worthy of emphasis:

David Fairchild
First time I have ever had a [r]eaction to a vaccine. Had it last evening, and now, redness at injection site (upper left arm), sore muscles, shivering cold ( and it is warm in here!). I had the Zostavax shot over 1 year ago, and my doctor recommended getting this one. No reaction to that one either. Flu shots and twinrix shots, no reactions ever.

Connie Bogumil George
I have RA and am on Humira. The shingrix isn't a live vaccine and my rheumatologist recommend I get it, however for me it wasn't without reaction. The first shot I had widespread ra symptoms for 24 hours every joint in my body ached. Shot 2 brought on more typical reactions of headache, dizziness, and nausea. My rheumatologist said this is supposed to happen as the shot triggers the immune system. Both times I had the site reaction which was tolerable. I would rather have the mold side effects instead of my crazy immune system bringing on shingles

Terri Carlson Lacy
NEVER AGAIN!! My Dr gave me the new shingles vaccine that was approved by the FDA in November. Im sicker than a dog! Every single joint in my body is killing me. My head is pounding,I feel like I have the flu. I woke up crying in pain in the middle of the night and cant even get out of bed today. If it causes these reactions in normal people , why would they give it to me with my genetic immune defect? My immune system is not handling it well at all. I will NOT be getting the second dose you need. My advice? Go with the old version of the vaccine.

At this point I wonder if those ITP'ers who have strong B cell responses (steroid responders), as Sandi describes with rodent/Rituxan biologics, may not be well suited for the vaccine. Having said that, I wonder if precautions can be made though - just like the pre-meds one would get before Rituxan. That is, I wonder if taking some steroids or dex before receiving the injection would take the edge off the inflammatory response.

I suspect other ITP'ers, like myself, can probably handle the vaccine without issue.

Cheers to no one getting Shingles !

That woman above, Terri, is describing serum sickness. That is exactly how I felt when I had it. I saw my GP a few weeks ago and he tried to push this vaccine on me. At the time, I didn't know about the hamster cells, but I did know that I want NO part of that vaccine. If I had known and objected based on that info, he would have told me it was okay to get it anyway. I hear that over and over from parents whose children have severe vaccine reactions.

The way I see it, if a person has an autoimmune disorder, they already have inflammation in their bodies. Vaccines are very inflammatory (especially the newer ones), so adding fire to an already burning body is a huge insult. You have no idea what you're going to stir up. Reactions do not always happen right away.

Hal, I don't have BMj access form home and haven't checked whether i do from work. If there's a specific article you're interested it, post or PM the link and I'll see if I can track it down.

Hey Hal:

Washington, DC — American Life League joined with Children of God for Life in praising GlaxoSmithKline for producing an ethically sourced shingles vaccine that was just recently approved by the FDA for licensing in the US. Shingrix is produced using a yeast cell line. Previously, the only available shingles vaccine, Zostavax, used aborted fetal cells.

www.all.org/all-praises-glaxosmithkline-for-manufacture-of-ethical-shingles-vaccine/


Physiological responses of Chinese hamster ovary cells to a productivity-enhancing yeast extract
www.sciencedirect.com/science/article/pii/S1389172318300938

I could only get a summary of that article. Looks like you need paid access for the whole thing.

Oh my Sandi. A serum sickness report right there in the Consumer Reports comments on Shingrix. Stunning.

Thanks for the follow up on growing hamster cells in yeast. That explains Mr Arumugham's comment now. I'm a little surprised no mention of yeast was in GSK's info. The science direct article didn't sound good on that.

If there was only some way to give someone Shingrix very, very slowly over a lonnnng period of time. Like what is available now with Rituxan for patients who are sensitive to it (eg dru). The 'desensitization protocol'.
hemonc.org/wiki/Rituximab_(Rituxan)_desensitization_protocol

Maybe dru can go have a talk with someone about it ? ? ?

Hal you can get serum sickness from anything - I had a horrible case of serum sickness and it was from a penicillin. Ended up in the ED, diagnosed and put on prednisone - it was that course of prednisone that made me say NEVER AGAIN will I take that stuff, and I'll be darned a few years later I was taking 60mg daily due to ITP.

There is a long list of things that can cause serum sickness. The problem here is that I'm sure most people don't ask what Shingrix is made from and even if they did, I doubt the doctor would know. If Hal hadn't mentioned it, I wouldn't have known. I have had the list of adjuvants but never looked at that one because I have no intention of getting it. Anyone who has had serum sickness from Rituxan should probably stay away from Shingrix. Do they know this? Probably not. Having a sensitivity to one thing can also mean a sensitivity to another. I've developed many over the years.

There are also antibiotics in vaccines, but so far, no penicillin.

"Certain antibiotics may be used in some vaccine production to help prevent bacterial contamination during manufacturing. As a result, small amounts of antibiotics may be present in some vaccines. Because some antibiotics can cause severe allergic reactions in those children allergic to them (such as hives, swelling at the back of the throat, and low blood pressure), some parents are concerned that antibiotics contained in vaccines might be harmful. However, antibiotics most likely to cause severe allergic reactions (e.g., penicillins, cephalosporins and sulfa drugs) are not used in vaccine production, and therefore are not contained in vaccines.

Examples of antibiotics used during vaccine manufacture include neomycin, polymyxin B, streptomycin and gentamicin. Some antibiotics used in vaccine production are present in the vaccine, either in very small amounts or they are undetectable. For example, antibiotics are used in some production methods for making inactivated influenza virus vaccines. They are used to reduce bacterial growth in eggs during processing steps, because eggs are not sterile products. The antibiotics that are used are reduced to very small or undetectable amounts during subsequent purification steps. The very small amounts of antibiotics contained in vaccines have not been clearly associated with severe allergic reactions." (Clearly associated - key words).

www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm

Hal, with all of the other things in that vaccine, you couldn't pay me to slowly desensitize and get that vaccine. I don't want that in my body. Also, there is no proof of long-term efficacy. The other one wasn't very effective.

Hal,
Have you talked to your hematologist about this yet? My primary care wanted me to take it yesterday at my annual physical. I declined because I have had Rituxan less than 6 months ago and so it might not be effective. I will ask my hematologist about it next time I see him-middle of October. I have never had a problem with vaccines. I really don't want to get shingles again.

Dru

Dru - I wouldn't be surprised if he doesn't have a clue what's in that vaccine (or any others). The last shingles vaccine caused shingles which can be the case with any live vaccine. This one isn't live, but I'm hearing that it packs a punch.

Hi, I just saw this thread. I am currently in partial remisssion from ITP and I have decided to get the shingrix vaccine. I've had the first shot without incident. My platelets usually bounce around 50K and I noticed no effect from the vaccine on my platelets. I was very sore at the site of the injection for about a day, but I once had a similar reaction to the flu shot.

My brother had shingles in his 40s and I really don't want it. However, I am someone who gets the flu shot solely for productivity reasons as I really don't need to take a week off work for the flu. Not only that, but I am paying for the shingrix shots and they ain't cheap. My insurance doesn't cover it and while the government will pay once I reach 65, I'm not there yet.

I'm actually getting the second shot tomorrow, so we'll see how that goes.

Lily

My hematologist feels I should get the immunizations I can [even though count dropped dramatically and needed treatment after a tetanus booster]. I too am in a partial remission but have no idea what my count is now, my IgG is low so had blood work done and the 16 year old tetanus booster is still protecting, the pneumonia shot is only covering 5 of the 14[13?] types the immunization is for, no protection for pertussis or diphtheria - will get the pneumonia vaccine and talk to doc about whether I really need pertussis and/or diphtheria. Also thinking of the Shingrix shots, even though I've had it twice the immunologist said I should have it. I get a flu shot every year.

Good for you Lily - hope all goes smoothly with the 2nd injection!! Keep us posted!