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Wednesday, October 16, 2019

All About Shingrix Shingles Vaccine - New England Journal Of Medicine

October 14th, 2019

Common Questions About the Shingles Vaccine — Answered Here!

National Library of Medicine
Here’s an interesting email from my friend and ID-colleague Dr. Carlos Del Rio (shared with his permission):
Went Tuesday to see my PCP for a routine visit and had my second dose of Shingrix that day. I had gotten my first dose about 3 months ago and had severe chills and even a fever of 38.5 after the first dose. With the second dose the response was not as severe but did have chills and rigors for about 18 hrs. Stupid of me, but the next day I went to get my labs checked, and everything was fine except my HS-CRP which was 14.72 (nl < 10 and in the past I had been < 1.0).
Anyway…..Shingrix is a good vaccine but it is a tough one to take and really gives you a nice TNF storm!
For the few of you out there in ID-World who don’t know him, you must understand it takes quite the force to slow down the high-energy machine that is Carlos. He is the very definition of indefatigable. So it’s not surprising he told me he went to work after both shots, rigors and all.
(Brief aside — congratulations, Carlos, on your well-deserved award!)
But Carlos’ post-shingles vaccine experience reminds me that we’re now two years into the recombinant zoster vaccine (RZV, Shingrix) era, and that immunization for this common adult infection — shingles, or zoster — has brought with it all sorts of new questions.
So here are a bunch of common ones we ID doctors field on a regular basis:
  • Who should get it? The vaccine is recommended for essentially all immunocompetent people over 50. So if you were born anytime before October 1969, this means you. People conceived during the Woodstock music festival or right after the Miracle Mets won the World Series are off the hook, at least for a few months longer. Two shots, separated by 2-6 months.
  • “Immunocompetent” adults — so nobody else? While immunosuppression is not a contraindication to the RZV, the data supporting its use in this population have not yet informed current guidelines. For now, it’s totally reasonable to offer RZV to people over 50 receiving low-dose immunosuppression, or to those with stable HIV on treatment, or to individuals who have had an autologous stem cell transplant. For higher degrees of immunosuppression, adopt an individualized approach — and remember that there is a theoretical concern that the adjuvant in the vaccine might stimulate organ rejection or a flare of an underlying autoimmune condition. We’ll see if this turns out to be a legitimate worry, so far it hasn’t.
  • No upper age limit? Use your judgment — if it’s a healthy 88-year-old with few medical problems, go ahead and give it. The risk of shingles increases as we age, and such a person will likely live several more years and could benefit from the vaccine. However, if it’s someone with multiple serious comorbid medical problems, then skip it. And yes, there are side effects — see Carlos’ email — which might be difficult for the frail elderly to tolerate.
  • What about people younger than 50 who have had shingles? While it’s understandable that they might be interested in the vaccine, it’s not been tested in people under 50, and is not formally recommended in this group. Reassure them that recurrent shingles is actually quite rare, especially within the first few years of an attack.
  • My patient never had chickenpox. Should they still get the zoster vaccine? Generally yes. For people born in the U.S. before 1980, essentially all have latent infection with varicella zoster virus — they either had a mild case of chickenpox or don’t remember having it. There might be a small fraction of people over 50 who never had chickenpox, test negative for antibody, and don’t want to risk the side effects of the vaccine. For them, consider the vaccine optional! (Many would recommend the chicken pox vaccine instead.)
  • How long after a case of shingles should my over-50 patient wait before getting the vaccine? No one knows. But since active zoster boosts a person’s immune response, it makes sense to wait at least until the current episode has completely resolved. I then add some additional time derived from the sophisticated ID time machine calculators. “At least 6 months” sounds reasonable, doesn’t it?
  • We had a shortage of the vaccine, now it’s now been more than 6 months since some of our patients had their first dose. Do they need to start over? Fortunately (for many reasons), no. Just give it when it becomes available.
  • Speaking of the shortage, what’s going on? Because of high demand for the vaccine, there have been widespread shortages of RZV ever since the vaccine became available. While these seem to have eased somewhat, especially in the last 6 months, not all practices or clinics or hospitals have it in stock. Fortunately, there’s a handy vaccine finder tool that I hear is quite reliable for pharmacies that offer the vaccine. Many hospital-based clinics also have it (we do).
  • Should I still give the new vaccine to people who got the old one? Definitely — not only is the RZV vaccine more effective, but that original live-virus vaccine (Zostavax) becomes less effective over time, and works less well when given to older patients, especially those over 70. If your patient got the live virus vaccine more than 6 years ago, they may not have any residual protection at all.
  • I hear the side effects are pretty bad — could they be worse than shingles? While no doubt the new zoster vaccine causes more side effects than most other vaccines, the clinical trials showed that serious side effects — those leading to death, hospitalization, need for urgent medical care — were no more common in vaccine recipients than in those who got placebo. Educate your patients that they might experience arm pain, fevers, fatigue, and myalgias and that these symptoms could be bad enough to have an impact on their daily activities. (This happened in 17% of study participants.) What this means practically is that I don’t recommend giving the zoster vaccine the day before a major life event, travel, or a demanding job requirement. And no harm taking a dose of acetaminophen or ibuprofen for symptom control.
But let’s go back to Carlos for a moment, and how these side effects he experienced compare to herpes zoster:
And to be clear, Shingrix side effects way milder than having shingles!
Completely agree! My experience — arm pain (check), fatigue (check), myalgias (check), and low-grade fever (check). But it was all over in a day, I promise.
And with the acknowledgment that we ID doctors see cases of zoster on the more severe end of the disease spectrum, we have all seen shingles accompanied by a host of really nasty complications. These include encephalitis, stroke, facial nerve paralysis, corneal involvement, vertigo, bacterial superinfection, and, most commonly, disabling unremitting pain (post-herpetic neuralgia) — pain for which there is often little effective therapy.
So the simple answer to the last question — are the side effects from the vaccine worse than shingles? — my answer is an emphatic no! I still strongly recommend it for my patients, colleagues, and friends of a certain age.
And look, my colleagues agree:
Back to the Summer of ’69 (the real one) …
(H/T, as always, to the incomparable Immunization Action Coalition site for clear, helpful information.)

10 Responses to “Common Questions About the Shingles Vaccine — Answered Here!”

  1. Loretta S says:
    Husband and I both got the first injection the same day. Wow, did our arms hurt for about 5 days. Around Day 3, I accidentally touched my husband’s arm while he was sleeping. He woke up immediately, and literally screamed. (Talk about feeling guilty!) But both of us know that a few days of pain is way better than having shingles. We’re due for injection #2 soon, and we will be there to get it!
    I had an 85-year-old patient get shingles 5 or 6 years after getting the ZVL vaccine. He had terrible PHN that I thought was more like CRPS, and has never completely recovered. So older patients who can tolerate the RVZ vaccine should get it!
    Any clue why the recommendation for RVZ is for adults 50+, but the recommendation for ZVL was, and remains, 60+ years old? Is that just an artifact of the clinical trial protocols?
  2. Jonathan Blum says:
    Regarding Loretta’s question, because the incidence of shingles is lower at 50-60 than >60, the benefit of vaccinating with ZVL at the lower age would have been much less. Given the short duration of immunity, protection would be wearing off as the risk increases. So although ZVL did work at 50-60, and was approved by the FDA for this age group, the CDC never recommended giving it to this age group. It’s not that unusual for FDA and CDC recommendations to differ. RZV may have a longer duration of protection.
    I spoke with a researcher at GSK earlier this year, and he told me the shortage was due to higher-than-expected demand related to the CDC taking the unusual step of recommending RZV over ZVL. He also pointed out that protection is good with a single dose, and it’s OK to give the second dose late (this is true for almost all vaccines), so we don’t need to sweat if a patient has trouble finding dose #2 “on time” due to the shortage.
    Another potential use of this vaccine is in children who got immunosuppressed at an early age (typically liver transplants due to biliary atresia) and never got their varicella vaccine. (They also don’t get MMR despite some evidence of safety, which is another story.) I have to wonder if RZV might be a way to protect those patients from VZV, but I am not aware of any evidence. If anybody has done this or heard about it, I would be interested in what is known.
  3. Mimi Breed says:
    As a genuine elderly patient with several comorbidities of the cardiovascular and metabolic variety (though I’m in pretty good shape for the shape I’m in) and who HAS HAD SHINGLES — lemme tell ya — YES GET THE VACCINE! SHINGLES IS HELL. Mine had no rash — yes, rashless shingles is a thing — so nobody could diagnose it for three months.
    Finally the pain doc to which I was referred figured it out, and by then then it was too late for any but palliative treatment. I had postherpetic neuralgia seemingly forever. As soon as vaccine became available I got vaccinated. When Shingrex came along I was first in line. I can’t even remember if I had side effects from the vaccines, but I’ll never forget the awfulness of shingles.
    Trust me — you don’t want to get shingles. GET THE VACCINE!
  4. Meredith Winger says:
    You mention that the vaccine is not recommended in people under age 50 who have had shingles because recurrent shingles is very rare. However, what if the person has already experienced recurrent shingles?
  5. mark says:
    I have a patient in her 60s who is taking Humira – is shingrix safe for her?
  6. Charles Carter says:
    I ran across a very good explainer and example of informed decision making a year and a half ago here- https://sciencebasedmedicine.org/should-i-get-the-new-shingles-vaccine/
    You acknowledge your support of the vaccine based on selection bias. I very much prefer Dr. Hall’s essay but it exemplifies the potential problems with shared decision making. And I realize I’m off base somewhat, as such is not the express intent of your current comments.
    While decision making based on highly selected experience will lead to no net harm in this situation, it certainly can do so in any number of other situations. So I appreciate your candor (and am undoubtedly guilty in other situations), comments to counter your bias might have been appropriate.
  7. Elena Massarotti MD says:
    Dear Paul,
    Thank you for this informative post, as usual! Our group recently submitted an abstract (accepted) to our national rheumatology meetings reporting our experience with administering the recombinant vaccine to over 400 rheumatology patients taking various immunosuppressants including TNF inhibitors, JAK inhibitors, methotrexate, steroids. Our retrospective review showed that the incidence of disease flares was ≤7% and side effects were 13.4%, lower than that observed in the general population. Both flares and side effects were mild, self-limited, and did not require a change in DMARD therapy. I’ve copied the link to the abstract below. Look forward to more formal studies examining safety and efficacy in this population! Thanks.
    Elena Massarotti
    Brigham and Women’s Hospital
    Division of Rheumatology
  8. Thomas Michel says:
    If not contraindicated because of health issues, I recommend taking ibuprofen right before the injection, and continuing ibuprofen as directed for 24 hours. Both based on personal experience and on first principles, NSAIDs may prevent or mitigate the inflammatory symptoms related to the immunization. Tylenol is less effective.

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