New Shingles Vaccine Approval and Recommendations

December 12, 2017 Karie Youngdahl

Shingles on Face
Shingles on face, Historical Medical Library of The College of Physicians of Philadelphia

In 2018 people in the United States over age 50 will have the opportunity to take a new, highly effective, long-lasting vaccine for shingles. The U.S. Food and Drug Administration approved the vaccine, Zoster Vaccine Recombinant, Adjuvanted (tradename Shingrix, manufactured by GSK) on October 20, 2017. On October 25, the U.S. Advisory Committee on Immunization Practices voted to recommend the vaccine for adults over age 50. The ACIP action specifically recommends Shingrix over Zoster vaccine, live (tradename Zostavax, manufactured by Merck), the only other licensed shingles vaccine. Additionally, ACIP recommends that adults who have already taken Zostavax be vaccinated with Shingrix.

One in three people will develop shingles in their lives. Shingles occurs in people who have previously had chickenpox –the virus that causes chickenpox (varicella zoster virus) remains in the body after recovery and may be reactivated years later. The risk of shingles increases with age. The illness usually presents with a painful, blistered rash along one side of the body. Commonly affected areas are the trunk, the face, and the neck. Many people with shingles experience post-herpetic neuralgia, a painful nerve condition, after the blisters disappear.

The ACIP preferential recommendation is an unusual situation for a variety of reasons. The Merck vaccine was approved in 2006 for those over age 50, but only recommended for those over age 60 because of evidence that immunity waned over time. The concern was that earlier receipt of the vaccine would lead vaccinees not to have adequate protection at the time they were at most risk of shingles and its complications. In contrast, the immunity generated by Shingrix is long lasting. Given that shingles risk increases particularly after age 50, earlier receipt of shingles vaccine will prevent many cases in those age 50-60. Another key difference between the vaccines is the degree of effectiveness: Zostavax is 64% effective at preventing shingles in people age 60-69. The GSK vaccine is 98% effective at preventing shingles in the same age group.

The antigen in Shingrix is a surface protein of the varicella zoster virus produced by culturing genetically engineered Chinese hamster ovary cells. Vaccination consists of two doses of vaccine, give at months 0 and 2-6. In some cases, people who want to take the vaccine will need to acquire it from a pharmacy if the healthcare provider does not stock it.

The heightened effectiveness of the vaccine is likely due in large part to the adjuvant the vaccine uses (an adjuvant is a vaccine component that heightens immune response – an aluminum compound is the most common adjuvant used in U.S. vaccines). The proprietary adjuvant in Shingrix includes two immune-stimulating compounds, a lipid and a purified saponin. As Didierlaurent et al. (2016) note, “Both immunostimulants in [the adjuvant] contribute to the local and transient induction of innate immunity immediately after the vaccine's injection, and this induction appears to be critical for the promotion of antigen-specific cell-mediated and antibody-mediated immunity.”

Several steps need to occur before people can get the vaccine. The Centers for Disease Control and Prevention will officially publish the ACIP’s recommendation in Morbidity and Mortality Weekly Reports, and commercial insurers, Medicare, and Medicaid will need to approve reimbursement (the shelf price of the vaccine is $280 for the two-dose series). Most commercial health insurance plans and Medicare Part D cover Zostavax, and the same will probably be true of Shingrix. The vaccine will likely be available in early 2018

I asked Thomas Fekete, MD, infectious diseases physician, College of Physicians Fellow and Trustee, and interim chair of the department of medicine at Temple University School of Medicine, for his thoughts about the new vaccine. His response is below.


Some vaccines are life saving such as measles or polio, and these are also vaccines that provide herd immunity to protect some of the unvaccinated. The current vaccine for shingles (medically known as herpes zoster) is a variation of the chickenpox (also called varicella) vaccine given to kids. Both of these vaccines are live virus vaccines and their administration produces a small locally contained infection that stimulates the immune system. In the case of chickenpox, the vaccine is highly effective in preventing the acquisition of varicella from other kids via the normal respiratory route.

Because herpes zoster can only occur in people who have already had chickenpox, neither of the shingles vaccines is intended to prevent the initial viral infection. They are, instead, intended to stimulate the immune system to resist the reactivation of existing virus. This reactivation triggers the symptoms of the disease, which include local burning, itching and rash. In addition, they help to prevent the most concerning sequela of shingles which is persistent, often severe, pain in the site of the reactivation. Neither vaccine provides herd immunity since adults with shingles almost never pass this virus along to others. 

The shingles vaccines differ in two important ways. Because the older one is a live virus vaccine, it is not as safe for people with significant immune disease such as advanced cancer, HIV, or treatment with immune suppressive drugs such as steroids or injectable medicines for rheumatoid arthritis. The new shingles vaccine, since it is not a live virus vaccine, does not carry these risks. The older vaccine had good but limited efficacy and a shorter period of protection as compared to the newer vaccine. That means that using the newer vaccine will reduce even further the possibility of a shingles outbreak and this, in turn, will prevent many cases of post-herpetic neuralgia. A third difference that we need to confirm over time is that the older vaccine did not provide any additional protection after the first administration. The newer vaccine should offer a longer period of protection and the option of a booster dose at a time when protection is waning.

Because these vaccines are directed only at adults, there is no worry about the decision maker being a proxy for the vaccinnee. The use of this vaccine is entirely voluntary, and it may cost money depending on the pharmaceutical benefits program. People with a fear of adjuvants may want to delay their decision to take this vaccine, although the medical community favors providing the vaccine as soon as it is widely available since the onset of shingles is unpredictable. I will be getting this vaccine as soon as I can even though I had the prior vaccine because I believe the degree of safety and protection is worth the cost. 


Post-licensure safety monitoring of the vaccine will be conducted by the vaccine manufacturer and via projects such as the Vaccine Safety Datalink.

If you are interested in receiving this vaccine, your physician should have information on its availability some time in early 2018.

Note: I edited this post 12/13/17 to fix an error about the storage temperature requirements of this vaccine. --KY 

Sources

Centers for Disease Control and Prevention. What everyone should know about shingles vaccine. https://www.cdc.gov/vaccines/vpd/shingles/public/index.html

Centers for Disease Control and Prevention. Shingles (herpes zoster).

Didierlaurent AM, Berger A, Heineman TC, Henderickx V, Da Silva FT, Vekemans J, Voss G, Garçon N. The Development of the adjuvant system AS01: A combination of two immunostimulants MPL and QS-21 in liposomes. Immunopotentiators in Modern Vaccines. 2016 Nov 2:265.

Tadeo M, Strauss M, Duarte E. What you need to know about the new shingles vaccine. Chicago Tribune. October 30, 2017.

Umansky D. The new shingles vaccine: What you should know. Consumer Reports. November 1, 2017.

U.S. Food and Drug Administration. Approval letter: Shingrix. October 20, 2017.

Comments

Posted by Jason (not verified)

Good article overall, but Shingrix does not need to be frozen - just refrigerated.  Also, the current version of Zostavax does not need to be frozen either.  The original version of Zostavax was frozen but it was phased out a few years back in favor of the newer refrigerated version.

Posted by Karie Youngdahl

Thanks for your comment, Jason, and for pointing out my error. I deleted the reference to freezing being required: prescribing information clearly states that the vaccine components should be stored between 2 and 8 degrees C (36-46 degrees F) and discarded if previously frozen.

-Karie Youngdahl

Posted by Susie Shapiro (not verified)

According to the Merck website, the Zostavax does need to be kept frozen, although, it may be refrigerated only for up to 72 hours, but then it needs to be discarded.

Posted by Paige (not verified)

I was wondering why the vaccination is only recommended for ages younger than 60. I understand the older in age the greater the risk of getting shingles but I have only known of two people ever getting shingles and they were infected before the age of 50. 

Posted by Karie Youngdahl

Hi, Paige -- the vaccine is recommended for people 50 and older. I suspect the reason it is not recommended for people younger than that is the it may not have been studied in that age population and that the risk for shingles in people younger than 50 is low and therefore would not warrant the cost/risk of vaccination. -Karie Youngdahl

Posted by Lulululu (not verified)

Paige, the article explains this - the older (live vaccine) doesn't cover for very many years, so it is targeted at the demographic most prone to shingles. The newer one covers longer and is expected to be offered to people 50 and over. 

Posted by Bob (not verified)

I was told by my pharmacist that this vaccine has Flu like symptoms as a side affect. 

Can you please verify this?

Thank you, Bob

Posted by Karie Youngdahl

Hello, Bob, Data from clinical trials indicates that side effects from the vaccine may include pain and swelling at the injection site (most common), and body aches, fever, and headaches. See the GSK press release about the ACIP meeting at which the vaccine was recommended.

Posted by Dolores (not verified)

Is it safe for type2 diabetic to take Shintix?

Posted by Karie Youngdahl

Hello, Dolores,  the CDC lists recommendations and contraindications for Shingrix. here: https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html 

Specifically, they say

"CDC recommends two doses of Shingrix separated by 2 to 6 months for immunocompetent adults age 50 years and older:

...

  • Who have chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease), unless a contraindication or precaution exists. Similar to Zostavax, Shingrix may be used for adults who are
    • are taking low-dose immunosuppressive therapy
    • are anticipating immunosuppression
    • have recovered from an immunocompromising illness"
Posted by Betsy (not verified)

Is the new Shingrix vaccine safe and recommended for a 61 year old male with stage 3/4 chronic kidney disease?

Is it best to check with his kidney doctor first?

What other vaccines, if any, would be generally recommended?

Posted by Karie Youngdahl

Hi, Betsy, here is the CDC's recommended immunization schedule for adults. For individual situations, consultation with physicians is always recommended. 

Posted by Lynne (not verified)

Is the new vaccine all dead?  I had a heart transplant in 2011. Is this safe for me to take?  I had the first vaccine in 2007 pre transplant. 

This seems to be much more effective, but can I take this new shot?

Posted by Karie Youngdahl

Hi, Lynne, the new vaccine does not contain live, attenuated virus. Your physicians will be able to answer your questions about whether the vaccine is right for you..--Karie Youngdahl

Posted by LYNN (not verified)

CAN YOU TAKE THIS VACCINE IF YOU HAD THE FIRST VACCINE 4 YRS AGO. NOW HAVE RA AND HAS GOTTEN SHINGLES RECENTLY .   NOT ON BIOLOGICAL.

Posted by Karie Youngdahl

Hi, Lynn, Your physicians will be able to answer your questions about the vaccine. -Karie Youngdahl

Posted by Lulululu (not verified)

Betsy, I just did considerable research on this ( 1/2 hour consult with my pharmacist plus NIH website, and other search +  useless consult with my nephrologist's clueless nurse) as I have kidney disease caused by vasculitis, and am about to start chemotherapy. All agreed it is safe, though a delay of at least 2 weeks, and ideally 1 month before starting immunosuppressant medications are recommended for the live vaccine. It was less clear whether it is also true for the new one. The issue in each case was the chemotherapy, not the kidney disease. Hope that helps! As you know, everything to do with kidneys is clear as mud. 

Posted by Aubrey (not verified)

If I never had chickepox, should I get this vaccination?

Posted by Karie Youngdahl

Aubrey, this is what the CDC says about your question [and this is not medical advice; you should consult your physician]:

Routine Vaccination of People 50 Years Old and Older

CDC recommends Shingrix® (recombinant zoster vaccine) as preferred over Zostavax® (zoster vaccine live) for the prevention of herpes zoster (shingles) and related complications. CDC recommends two doses of Shingrix separated by 2 to 6 months for immunocompetent adults age 50 years and older:

  • Whether or not they report a prior episode of herpes zoster
  • Whether or not they report a prior dose of Zostavax
  • Who have chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease), unless a contraindication or precaution exists. Similar to Zostavax, Shingrix may be used for adults who are
    • are taking low-dose immunosuppressive therapy
    • are anticipating immunosuppression
    • have recovered from an immunocompromising illness
  • Who are getting other adult vaccines in the same doctor’s visit, including those routinely recommended for adults age 50 years and older, such as influenza and pneumococcal vaccines. The safety and efficacy of concomitant administration of two adjuvanted vaccines, such as Shingrix and Fluad, have not been evaluated.
  • It is not necessary to screen, either verbally or by laboratory serology, for evidence of prior varicella infection
Posted by Karie Youngdahl

And from the same publication: 

For patients who do not report a prior episode of varicella

When vaccinating adults age 50 years and older, there is no need to screen for a history of varicella (chickenpox) infection or to conduct laboratory testing for serologic evidence of prior varicella infection. More than 99% of adults age 50 years and older worldwide have been exposed to varicella zoster virus, and the Advisory Committee on Immunization Practices (ACIP) considers people born in the United States prior to 1980 immune to varicella. Therefore, even if a person does not recall having chickenpox, serologic testing for varicella immunity is not recommended. It is often a barrier to herpes zoster  vaccination, and false negatives are common. However, if serologic evidence of varicella susceptibility becomes available to the healthcare provider, providers should follow ACIP guidelines for varicella vaccination. Shingrix has not been evaluated in persons who are seronegative to varicella, and it is not indicated for the prevention of varicella.

Posted by robfordeh (not verified)

I am 69 years old, 70 in September I have had shingles at least a dozen times. Therefore not eligible for the vaccine. In the past I have tried my best to see if i could get it, but was refused on age grounds. I have also read online resources like mayo clinic, Everydayhealth etc. I now hear that two hundred thousand didn't take this vaccine up. I now am on a permanent anti viral medication. Why couldn't I have had the vaccine? Also now I have had it so many times will the vaccine work?

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