New Shingles Vaccine Approval and Recommendations
New Shingles Vaccine Approval and Recommendations
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
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.