In October, 2017 the Food and Drug Administration approved the use of a new vaccine for the prevention of shingles (herpes zoster). The new vaccine is called Shingrix and in early testing appears to be a remarkable improvement over the previous vaccine (Zostravax) which was approved in 2006. Since January, 2018 the new vaccine has become more generally available, is being approved by more and more insurances, and has been getting very favorable, though not always accurate, reviews in the popular media.
Should you get the new vaccine or not?
If you are under the age of 50 and in generally good health, you need read no further. The vaccine is not approved for use under the age of 50 (though there might be exceptional circumstances when its use would make sense). Otherwise, read on.
The new vaccine differs from the earlier vaccine in certain important ways. The previous vaccine is a live virus. That means it should not be given to immunocompromised individuals who might then become sick. Shingrix is not a live virus but a non infectious part of the virus (recombinant glycoprotein E in case you would like to know) mixed with a so-called “adjuvant” which makes it work better. The mixing of those two components must be done right before the vaccine is given. Theoretically, Shingrix can be given to immunocompromised individuals.
The previous vaccine is given in one dose just under the skin (subcutaneous injection) but not in the muscle; Shingrix is given into the muscle (intramuscular injection) in two doses 2-6 months apart and shouldn’t be given just under the skin. The previous vaccine is stored frozen; Shingrix no longer works if it is frozen. What all that means to you is that it is doubly important that the person giving you the vaccination knows how to store it properly, how to mix it properly, and how to inject it properly.
The attractive features of the new vaccine are that it is over 90% effective at all ages whereas the earlier vaccine was about 40% effective when given at age 60 years and only about 20% effective when given at age 80 years. The previous vaccine loses effectiveness in about five years. Shingrix appears to maintain its effectiveness over time and may confer lifelong protection, though we don’t really know what happens after five or six years.
The bad news is that Shingrex has more side effects than the previous vaccine. The most common of these is localized pain, swelling, and redness at the injection site. This problem occurs in about 8 out of 10 individuals. In about 1 out of 10 individuals the discomfort is severe enough that they are not able to continue their daily activities (that’s called a grade 3 reaction in case you wanted to know). The good news is that it usually goes away in about 3-4 days.
The other bad news is that there are other side effects besides pain. 1 out of 10 have level 3 (cannot do your usual things) side effects like generalized muscle aches, tiredness, headaches, shivering, fever, and what is euphemistically called stomach upset but which you and I refer to as diarrhea, vomiting, and things like that. You get over those things in a few days too. Or maybe a little longer.
In general, you should expect to experience some level of localize pain (78%), aching muscles (45%), and being worn out (45%) for a few days after your first injection. You should be prepared to cancel any special plans you have made for the week following your injection. So plan ahead.
You might be wondering what happens after the second injection 2-6 months later. Same problems but you cannot predict based on the first time. You might breeze through the first injection with minimal side effects and spend the week after your second in bed (or the bathroom) or the other way around.
And what happens if you don’t get the second injection? Well, we do not really know, but it is likely any prevention of shingles will not last as long.
The worst news, however, is what we do not know. Many medicines and vaccines have been approved in the past only to find out later that there were major problems not detected in the testing done prior to their approval for general use. The good news is that the prerelease testing of Shingrix did not reveal any major problems. So far, so good.
And all of that brings up the question of is it really worth it in the first place? Is what it takes to prevent shingles worse than shingles itself? In some yes; in others maybe no; in others just maybe. Let’s start with a few basic facts about shingles.
Shingles is the popular name for what is medically called herpes zoster. Herpes zoster is caused by the same virus that causes chickenpox. If someone has chickenpox, the virus never leaves the body but stays in something in the spinal cord called the dorsal
root ganglia. For most of our lives it just stays there and causes no apparent problems. But for usually unknown reasons the body sometimes gives it a get out of jail free card, and it escapes along a nerve that goes to one side of the body. The virus infects the
skin related to that nerve, and a blistering rash appears on the one side of the body corresponding to that nerve’s location—it could be one side of the face, one arm, one leg, one side of the chest or stomach.
Usually untreated shingles worsens and spreads for about a week to ten days and recedes in two to three weeks.
There are currently three approved antiviral medications that are used to treat most shingles. All have a very good safety profile. All are extremely effective in treating shingles and its consequences. The earlier the treatment begins, the better the results. None have the kind of side effects that Shingrix has.
Certainly, it would be preferable to prevent shingles altogether with a vaccine than to treat it after it appears. But the important point is that there is an effective alternative to the shingles vaccine—namely early treatment with a generally safe medication. The second point to consider is that most shingles doesn’t cause major problems, especially if properly treated. One can get the impression from television ads that all shingles does horrible things. Not true. One can also get the impression from the stories of friends that all shingles is awful. Most people do not talk about a relatively mild case. It is the problem case that gets retold over and over again. Of the hundreds and hundreds of cases of shingles I have treated, I could count those with long term problems on the fingers of one hand—with a few fingers left over.
The third point is that Shingrix does not prevent all shingles. You can come down with shingles even if you have had the vaccine.
But standing against all three of those points is that sometimes shingles does cause serious and long term problems such as persistent pain in the area where shingles appeared (called post herpetic neuralgia). That pain can sometimes be very hard to effectively treat. Other even more serious problems occur when the shingles involves areas like the eye or even the brain. Again, the current treatments are very effective in preventing those problems in the first place, but nothing is perfect, including Shingrix.
All of that brings us back to the measuring scale that doctors use everyday—risk versus benefit. We do not fully know the true risk or true benefit of any new medication or vaccine—including Shingrix. But we do know something about your risks of getting shingles.
First of all, the older you are the more likely it is that you will get shingles and the more likely you will have complications like post herpetic neuralgia. If your immune system is down for some reason such as occurs if you have an immune deficiency disease, if you are on chemotherapy, if you are on immunosuppressive medications, or if you have internal cancer, you are more likely to get shingles. In my experience patients with insulin dependent diabetes tend to have more complications from shingles than average.
Here’s what the CDC (Center for Disease Control) recommends:
- Shingrix (the new vaccine) is preferable to Zostavax (the older vaccine)
- The CDC recommends all immunocompetent adults over age 50 years receive two doses of Shingrex 2-6 months apart whether they have had shingles before or not and whether they have had the Zostavax before or not. (Though they recommend waiting at least two months from the Zostavax shot before having Shingrix).
- They also recommend adults with chronic medical conditions such as renal failure, diabetes, rheumatoid arthritis, or chronic pulmonary disease get the new vaccine
- They also think it is appropriate for individuals on low dose immunosuppressive therapy, anticipating immunosuppression, or are recovering from an immunosuppressive illness to get the vaccine (but not necessarily taking a position on whether they should).
- That it is ok to get other adult vaccines such as influenza or pneumonia at the same time as getting Shingrix
- That it is ok to get the vaccine even if you do not know if you had chickenpox (although if for some reason you know that you are seronegative—meaning no antibody evidence of previous chickenpox—you should get the chickenpox vaccine before the shingles vaccine since 1. You won’t get shingles if you never had chickenpox 2. The shingles vaccine will not prevent chickenpox.)
Ok, so I am over 60 years old and remember having rather severe chickenpox growing up. I am also in good health. The CDC recommends I get two doses of Shingrix 2-6 months apart. Am I going to do that? No. At least not right away. I am going to wait until it has been on the market for one year and then get it. (Unless we learn bad things about it.). Also I am not going to get my influenza shot at the same time that I get my shingles shot because I like to spread out my side effects so I can get full enjoyment from them. (I have already had my two pneumonia shots. If you are older than 65 years old, you should as well if you haven’t already.) What you should do if over fifty is up to you. Wait a year like me or go for it. But here are a few things to consider.
Age 50-60 AND IN GOOD HEALTH
Your risk of getting shingles is relatively low. (5 cases per 1,000 individuals from age 50-59 which seems to work out to one chance in 2,000 over the next year.) The likelihood of significant problems from shingles if you get it is very low, especially if you have it treated with current medications. We do not really know how long the new vaccine is effective. We think maybe the rest of your life. But what if it is 10-15 years and then wears off? If you are in your early 50’s, 10-15 years is when you will really need it. Maybe a booster would work. Maybe not. What if we learn that it causes some terrible problem 10-20 years later? Not a consideration if you are 90 when you get the vaccine. Finally, are you doing the other things you should be doing in your fifties. Getting regular excise? Not smoking? Controlling your weight? Avoiding excess alcohol?
Have a general physician who is checking blood pressure, doing appropriate blood and urine tests, and keeping your other immunizations up to date? Had your colonoscopy yet? If the answers to the above are no, why are you worrying about shingles? If you are going to move ahead and get the vaccine (and the CDC thinks you should), here are some suggestions:
1. Make sure you do not have any plans that you do not want to cancel in the week following your immunization.
2. Carefully, consider where you get the injection and who gives it to you. Whoever gives it to you should first go over the list of contraindications (reasons you should not get it) with you such as whether you are allergic to any of the immunization’s components. Unless your regular doctor runs a very efficient office, I would suggest getting it from a pharmacist who has given it before because 1. It needs to be stored properly and not frozen the way the previous vaccine was stored. Pharmacies are in the business of storing medicine properly. 2. It needs to be mixed prior to administering and pharmacists do that kind of thing all day long 3. It needs to be given intramuscularly and not subcutaneously like the previous vaccine. A pharmacist who regularly administers it is more likely to get it right than a medical assistant who has not ever given it before. 4. You might ask in a non threatening way whether the person giving injection has given it before (“Are a lot of people getting this vaccine?” “I heard that this vaccine is injected differently than the other shingles vaccine. Is that really true?” Or something along those lines.)
3. While it is ok to get another immunization at the same time as Shingrix, consider doing it at another time. It is highly likely that you are not going to be at the top of your game for a few days after the shot.
OVER 60 AND IN GOOD HEALTH
Ok, that’s me. It’s a tough call. Over age sixty the risk of getting shingles goes up and the likelihood of significant side effects goes up. I have the advantage that I can prescribe an antiviral medication at the very beginning of shingles if I get it. In my opinion it is reasonable but not essential to wait a year if you are generally in a position to seek medical care at the first sign of an outbreak of shingles. If not, you should probably go for it. The older you are, however, the greater the risks of shingles. If you are at the stage of not buying green bananas, get the shot. If you are someone who is likely to second guess yourself later if you get severe shingles, get the shot. If you know you are allergic to the medications used to treat shingles, get the shot. If you decide to get the Shingrix immunization, see my recommendations for 50-60 year olds who get the immunization. They are the same for you.
Now it gets tricky, and it is hard to give general advice. The more moving parts (or not moving parts whatever the case may be) in your life, the tougher the call. But if you and the physicians treating you for other conditions think it reasonable to move ahead with
the immunization, then you really should. All indications are that Shingrix is a major advance in preventing shingles. And it is most likely safe. My orientation as a doctor is to be skeptical of those things which have not passed the test of time. The general rule
in medicine has always been to “first do no harm.” With any new medicine we never really know how to measure the harm. But there are times when the greater harm is in not using a new medicine or treatment. And if you have any medical conditions that
make it likely you are more prone to shingles and more prone to severe complications from shingles, then that tips the scales. We are fortunate to live in a time and place where we have access to real medical advances that make our lives better. Shingrix is probably one of those. Don’t let side effects which are temporary deter you from doing what is best for your health.
Henry E Wiley III MD
June 24, 2018