Beth Longware Duff

 to expand its approval of Shingrix to include immunocompromised adults 18 years and older is the first step toward providing protection against shingles to more at-risk individuals. The vaccine, manufactured by GlaxoSmithKline, was originally approved by the FDA in 2017 for immunocompetent adults aged 50 and older.

The FDA’s move is based on clinical studies examining the safety and efficacy of Shingrix in patients aged 18 and older who had undergone an autologous hematopoietic stem cell transplant or treatment for hematological malignancies. Additional data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed because of known disease or therapy. This group included patients with HIV, solid tumors, and renal transplants.

“Older age and being immunocompromised are the most common risk factors for shingles disease,” explained Thomas Breuer, chief medical officer of GSK Vaccines, in a prepared statement. “GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition.”

A cross-sectional analysis of data from the 2013 National Health Interview Survey administered by the US Census Bureau revealed that more than 4% of adults surveyed had been told by a physician that they were immunocompromised. Almost 3% of those surveyed reported current immunosuppression. The rate was highest in women, White individuals, and people aged 50 to 59 years.

Immunocompromised individuals are at greater risk for developing opportunistic infections and experiencing the reactivation of chronic infections, as well as other health problems. In addition, patients are often unable to receive vaccines because of their condition.

Immunocompromised individuals are at greater risk of developing shingles and associated complications, including postherpetic neuralgia, than immunocompetent individuals. Age, gender, race, and overall health are risk factors for developing shingles in the general population.

In his statement, Breuer noted that in addition to the immunocompromised patient population, more than 100 million adults aged 50 and older in the United States also are eligible to receive Shingrix.

Virtually all individuals over the age of 40 carry the varicella zoster virus associated with shingles. The virus initially causes chickenpox and then is dormant in the nervous system for decades before reactivating to cause shingles.

Shingrix is administered in 2 doses given 2 to 6 months apart. For immunocompromised adults who would benefit from a shorter vaccination schedule, GSK states that the dosing schedule can be changed to 1 to 2 months. 

Shingrix is included on the 2021 vaccination schedule for adults issued by the CDC’s Advisory Committee on Immunization Practices (ACIP). The committee is reportedly considering recommendations for the vaccine’s use in immunocompromised adults.

Shingrix is not contraindicated in immunocompromised persons but is not recommended by ACIP at this time, according to the 

 The committee will review evidence for modifying its vaccine policy as it becomes available.

 The guidance states that Shingrix can be administered to individuals who are taking low-dose immunosuppressive medication or are anticipating immunosuppression, and to those who have recovered from an immunocompromising illness.

Shingrix approved in the US for prevention of shingles in immunocompromised adults. News Release. GSK; July 26, 2021. Accessed July 30, 2021. 

https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-immunocompromised-adults/

Boggs W. One in 40 Americans Immunosuppressed. 

 November 1, 2016. Accessed August 1, 2021. 

https://www.hmpgloballearningnetwork.com/site/pln/content/one-40-americans-immunosuppressed

Frequently Asked Questions About Shingrix. 

Centers for Disease Control and Prevention.

https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/faqs.html

Articles

FDA gives OK to shingles vaccine for those at risk 

Shingrix Approved for Immunocompromised Adults				

According to results from a new study on the effect of Shingrix in individuals with inflammatory bowel disease (IBD), the recombinant zoster vaccine (RZV) is associated with a decreased risk of shingles infection among the 2 age groups studied.

The authors of the retrospective cohort study, which was conducted in the Veterans Affairs (VA) health care system, noted that individuals with IBD are at an increased risk of herpes zoster (HZ) infection. Their greater susceptibility to the varicella zoster virus, which causes shingles, is linked to the immunosuppressive treatments they receive for their disease.

The study investigators acknowledged that although the efficacy of the Shingrix vaccine has been proved to be high among immunocompetent individuals, little was known about its effect among immunosuppressed individuals with IBD.

“Previous literature has suggested that the risk of herpes zoster is 1.2-1.8 times higher in the IBD group compared to the general population, with higher risks among patients using thiopurines, a combination of anti-TNF [tumor necrosis factor] and thiopurines, and corticosteroids within the previous 30 days,” wrote lead author Nabeel Khan, MD, of the Department of Gastroenterology at Corporal Michael J. Crescenz VA Medical Center in Philadelphia.

The study involved patients who had received an IBD diagnosis on or before January 3, 2018, the earliest date the RZV was administered. The investigators collected data on 2 groups of eligible patients: 7008 in the 50- to 60-years group and 26,292 in the over-60-years group.

“We identified veterans who received RZV and compared the incidence of HZ between vaccinated vs unvaccinated individuals,” the authors wrote. “We performed multivariable Cox regression with time varying analysis to determine the risk of HZ among the vaccinated (full dose and single dose separately) vs unvaccinated cohort, stratified by IBD medications.”

They reported that compared with the unvaccinated group the crude HZ incidence rate after a full-dose vaccination of RZV was lower in both the 50- to 60-years group (0.00 vs 3.93 per 1000 person-years) and the over-60-years group (1.80 vs 4.57 per 1000 person-years).

Shingrix vaccination was associated with a significantly lower risk of HZ among those aged 50 to 60 years and among those older than 60 years, although the finding was limited by low HZ event rates. The authors concluded that greater efforts should be made to vaccinate all patients with IBD with Shingrix, the only shingles vaccine available in the United States.

According to the CDC, the majority of the 3 million adults in the United States with IBD received their diagnosis in their 20s and 30s, decades before reaching the current age requirement of 50 for receiving Shingrix.

 The agency recommends Shingrix for the prevention of shingles and related complications in adults 50 years and older, particularly for individuals with chronic medical conditions, unless a contraindication or precaution exists.

The Crohn’s & Colitis Foundation reports that as many as 70,000 new cases of IBD are diagnosed in the United States annually.

 Further, there may be as many as 80,000 children in the country with IBD. All these individuals are at a potentially greater 

 for developing shingles, which could be prevented through vaccination.

Khan N, Wang L, Trivedi C, et al. Efficacy of recombinant zoster vaccines in patients with inflammatory bowel disease.

Inflammatory Bowel Disease (IBD) in the United States. Centers for Disease Control and Prevention. Accessed August 1, 2021. 

https://www.cdc.gov/ibd/data-statistics.htm

Shingrix Recommendations. Centers for Disease Control and Prevention. Accessed August 1, 2021. 

https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html

The Facts About Inflammatory Diseases. Crohn’s & Colitis Foundation of America. November 2014. Accessed August 1, 2021. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.

Study findings reveal decreased risk of HZ infection

Shingrix Is Highly Effective for Patients With IBD 				

The red rash and lesions associated with 

 (herpes zoster) can erupt anywhere on the human body. It all depends on which nerves are affected by the 

) that remained in the body after an earlier case of chickenpox.

Although the front and back of the torso are the usual sites of the rash, the face will be affected when the virus reactivates in the trigeminal nerve, which handles face and motor functions. When this happens, the patient is at risk for potentially serious complications like facial pain, numbness, tingling, or paralysis; damage to the eyes, and hair loss.

The shingles rash generally appears on just 1 side of the affected body part, and the face is no exception. The fluid-filled blisters can extend to cover the mouth, eye, ear, forehead, nose, and 

. Early diagnosis and treatment can help limit the length of the infection and its complications, including 

Two of the most serious threats from shingles on the face are herpes zoster ophthalmicus (affecting the outer and inner eye) and herpes zoster oticus, which involves the ear.

), or ocular shingles, is a growing health risk in the United States, according to an article published in the American Academy of Ophthalmology’s (AAO) 

 It reports that cases are on the rise and account for approximately 10% of all shingles cases.

Fever, headache, and tingling forehead and scalp are all early symptoms of shingles of the eye that emerge ahead of the rash. Subsequently, the patient experiences eye redness and pain, eyelid swelling, and sensitivity to light. Complications include chronic pain, increased pressure within the eye, and 

. In addition to seeing a health care provider to diagnose and treat shingles, HZO warrants a visit to an ophthalmologist to help prevent permanent damage to the eye.

Additionally, HZO is associated with cerebral stroke, according to the AAO article. “Within one year of a patient’s initial episode, those with HZO have a risk of stroke 4.3 times higher than that of all HZ patients (whose risk is 1.3 times that of controls),” the authors wrote.

When VZV reactivates in one of the facial nerves near the ear, the result is herpes zoster oticus, also known as 

. The rash covers the outer part of the ear and the external ear canal, causing facial weakness, palsy, or paralysis on the same side of the face. It can also spread to the mouth, soft palate, and upper throat. Patients may have trouble speaking, smiling, and closing the eye on the affected side. Tinnitus, hearing loss, and vertigo may develop and become permanent if the condition is left untreated.

Another area of concern is oral shingles involving the mouth and gums. Blisters in the mouth make chewing very painful, cause nerve damage that results in sensitivity and numbness affecting the ability to taste, and increase the risk of oral infections.

 with antiviral drugs, preferably within the first 72 hours after the rash appears. Immediate attention is required to prevent a worsening of symptoms as well as scarring and damage to the face.

The only way to prevent shingles once VZV is in the body is through vaccination. Shingrix is a 2-dose vaccine that has been proven to be 

 in both clinical trials and real-world applications. The FDA recommends Shingrix for the prevention of shingles in healthy adults aged 50 years and older.

1. Lewis K, Palileo B, Pophal C, et al. Herpes zoster ophthalmicus. 

 2020. https://www.aao.org/eyenet/article/herpes-zoster-ophthalmicus-pearls

Potential for serious complications is very real.

Shingles On the Face: Complications and Treatment

 virus (VZV) is particularly resilient. It is one of more than 130 identified herpes viruses that cause infections and diseases in mammals. In humans, VZV is responsible for 2 separate and distinct infections that typically occur decades apart: chickenpox and shingles.

VZV first infects the body as chickenpox (varicella), a highly contagious but relatively minor infection that primarily affects young children, although it can be far more 

The first symptoms of chickenpox are sudden-onset fever, fatigue, headache, body aches, and loss of appetite. A blistering, itchy rash emerges a couple of days later, usually beginning on the face, back, or chest and spreading quickly to the rest of the body.

The virus is most likely to spread during this active phase of the infection, either through direct contact with the lesions or through breathing in viral particles from the lesions. The contagious period for chickenpox runs from 1 to 2 days before the rash erupts until all the blisters have scabbed over.

The chickenpox patient recovers, but VZV remains in the body. It lies dormant in the nervous system for decades until it 

 are a tingling, itching, or stabbing pain on the skin. Within a few days, the rash appears, starting as a band of raised lesions on one side of the face, torso, or other areas of the body. The lesions soon develop into red, fluid-filled blisters that eventually break open, dry up, and crust over.

Symptoms during the rash can vary from mild itching to intense pain which typically subsides after 3 to 5 weeks. Early treatment with antivirals can help to shorten the course of the infection and reduce complications.

. However, if a person who has never had chickenpox or been vaccinated against it comes in contact with fluid from the shingles blisters, they are likely to contract chickenpox. Once VZV is in their body, they are also at 

Fortunately for individuals at both ends of the age spectrum, chickenpox and shingles are preventable through vaccination.

The 2 options for vaccination against chickenpox are 2 doses of the varicella vaccine or the combination MMRV vaccine that guards against measles, mumps, rubella, and varicella.

 for children, adolescents, and adults who have never had chickenpox and were never vaccinated. The first dose is administered to children between the ages of 12 and 15 months, and the second dose follows when they are 4 to 6 years old. Two doses are more than 90% effective at preventing chickenpox. 

To prevent shingles, the CDC recommends that healthy adults aged 50 and older receive Shingrix, the only herpes zoster vaccine available in the United States. The vaccine is given in 2 doses administered 2 to 6 months apart. Individuals who have previously had shingles or received the earlier shingles vaccine Zostavax can also receive Shingrix.

 to be over 90% effective in preventing shingles and associated complications, and it is 

One virus causes 2 infections decades apart.