Zoster Shingles Vaccine Hzv Recombinant

Routine Vaccination Of People 50 Years Old And Older

CDC recommends Shingrix for the prevention of herpes zoster and related complications. CDC recommends two doses of Shingrix separated by 2 to 6 months for immunocompetent adults aged 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, a shingles vaccine that is no longer available for use in the United States.
• It is not necessary to screen, either verbally or by laboratory serology, for evidence of prior varicella.

Recombinant and adjuvanted vaccines, such as Shingrix, can be administered concomitantly, at different anatomic sites, with other adult vaccines, including COVID-19 vaccines. Coadministration of RZV with adjuvanted influenza vaccine and COVID-19 vaccines is being studied.

Efficacy In Subjects 50 Years And Older

Study 1 was a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. Randomization was stratified by age: 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80 years. The study excluded, among others, subjects who were immunocompromised, had a history of previous HZ, were vaccinated against varicella or HZ, and patients whose survival was not expected to be at least 4 years or with conditions that might interfere with study evaluations. Subjects were followed for the development of HZ and postherpetic neuralgia for a median of 3.1 years . Suspected HZ cases were followed prospectively for the development of PHN, an HZ-related complication defined as HZ-associated pain occurring or persisting at least 90 days following the onset of rash in confirmed cases of HZ.

The primary efficacy analysis population included 14,759 subjects aged 50 years and older who received 2 doses of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose. In the mTVC population, 61.2% were female 72.3% were white, 18.9% were Asian, 1.7% were black, and 7.0% were of other racial/ethnic groups. The mean age of subjects was 62.3 years.

Confirmed HZ cases were determined by either Polymerase Chain Reaction or by a Clinical Evaluation Committee .

Efficacy against Herpes Zoster

Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ by 97.2% in subjects 50 years and older .

Attention: Pharmacists Who Administer Vaccines Zoster Vaccine Recombinant Adjuvanted Suspension For Intramuscular Injection Cpt Code : Billing Guidelines

Effective with date of service November 8, 2017, the North Carolina Medicaid Program covers claims for pharmacist administration of Zoster Vaccine Recombinant, Adjuvanted, Suspension for Intramuscular Injection for use in the Physicians Drug Program with CPT code 90750 Zoster vaccine, , recombinant, sub-unit, adjuvanted, for intramuscular injection.

The suspension for injection is supplied as a single-dose vial of lyophilized varicella zoster virus glycoprotein E antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of Shingrix is 0.5 mL. Shingrix is indicated for prevention of herpes zoster in adults aged 50 years and older. Shingrix is NOT indicated for prevention of primary varicella infection .

The recommended dose of Shingrix is two doses administered intramuscularly according to the following schedule: A first dose at month 0 followed by a second dose administered anytime between 2 and 6 months later. See prescribing information for details.

For Medicaid Billing:

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Put Shingrix On Your To

Even the healthiest lifestyle cant stop your immune system from declining as you age, increasing your risk of shingles. Over 99% of people 50 years and older have the virus that causes shingles already inside of them. 1 out of 3 people will get shingles in their lifetime.

Sign up for text message reminders, and well help you remember to add SHINGRIX to your to-do list on the day that works best for you.

SHINGRIX is an FDA-approved vaccine for the prevention of shingles in adults 50 years and older.

SHINGRIX is an FDA-approved vaccine for the prevention of shingles in adults 50 years and older.

SHINGRIX is an FDA-approved vaccine for the prevention of shingles in adults 50 years and older.

SHINGRIX is not used to prevent chickenpox.

• You should not receive SHINGRIX if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of SHINGRIX
• An increased risk of Guillain-Barré syndrome was observed after vaccination with SHINGRIX

• You should not receive SHINGRIX if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of SHINGRIX
• An increased risk of Guillain-Barré syndrome was observed after vaccination with SHINGRIX

You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967.

When Should I See A Doctor Because Of The Side Effects I Experience From Shingrix

Shingrix causes a strong response in your immune system, so it may produce short-term side effects. These side effects can be uncomfortable, but they are expected and usually go away on their own in 2 or 3 days. You may choose to take over-the-counter pain medicine such as ibuprofen or acetaminophen. Contact your healthcare provider if the symptoms are not improving or if they are getting worse.

In clinical trials, Shingrix was not associated with serious adverse events. In fact, serious side effects from vaccines are extremely rare. For example, for every 1 million doses of a vaccine given, only one or two people might have a severe allergic reaction. Signs of an allergic reaction happen within minutes or hours after vaccination and include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness. If you experience these or any other life-threatening symptoms, see a doctor right away.

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Guidance On Reporting Adverse Events Following Immunization

Vaccine providers are asked to report AEFIs through local public health officials and to follow AEFI reporting requirements that are specific to their province or territory. In general, any serious or unexpected adverse event felt to be temporally related to vaccination should be reported.

For LZV the following AEFIs are also of particular interest and should be reported:

• Suspected transmission of vaccine-strain virus to a close household or occupational contact. This phenomenon has been documented following varicella vaccine but it is rare, and transmission has not been documented with LZV.
• Recurrent HZ following immunization of individuals with a history of HZ prior to immunization, noting the area of recurrence.
• Recurrent HZO following immunization of a person who has had a previous episode of HZO. If available, a vitreous fluid specimen should be sent to a laboratory with a request to determine whether the virus is the vaccine strain or wild type virus.

For definitions of serious and unexpected adverse events, refer to Adverse Events Following Immunization in Part 2.

For more information refer to Reporting Adverse Events Following Immunization in Canada.

Talk With Your Health Care Provider

Tell your vaccine provider if the person getting the vaccine:

• Has had an allergic reaction after a previous dose of recombinant shingles vaccine, or has any severe, life-threatening allergies.
• Is pregnant or breastfeeding.
• Is currently experiencing an episode of shingles.

In some cases, your health care provider may decide to postpone shingles vaccination to a future visit.

People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill should usually wait until they recover before getting recombinant shingles vaccine.

Your health care provider can give you more information.

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Use In People With A History Of Herpes Zoster

People with a history of herpes zoster were excluded from the Shingles Prevention Study , so there are no data on vaccine efficacy in this group.

One small clinical trial studied the safety and immunogenicity of Zostavax in people with a history of herpes zoster. Zostavax was well tolerated and immunogenic.59

Billing Guidelines: Zoster Vaccine Recombinant Adjuvanted Suspension For Intramuscular Injection Cpt Code 90750

CSRA

Effective with date of service Nov. 8, 2017, the North Carolina Medicaid program covers zoster vaccine recombinant, adjuvanted, suspension for intramuscular injection for use in the Physicians Drug Program when billed with CPT code 90750 – Zoster vaccine, , recombinant, sub-unit, adjuvanted, for intramuscular injection.

The suspension for injection is supplied as a single-dose vial of lyophilized varicella zoster virus glycoprotein E antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of Shingrix is 0.5 mL. Shingrix is indicated for prevention of herpes zoster in adults aged 50 years and older. Shingrix is not indicated for prevention of primary varicella infection . The recommended dose of Shingrix is two doses administered intramuscularly according to a schedule of a first dose at month zero followed by a second dose administered anytime between two and six months later.

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Rate Of Complications From Herpes Zoster

Overall, 1326% of patients with herpes zoster develop complications. Complications occur more often in older people and people who are immunocompromised.51,52

Post-herpetic neuralgia is the most common complication of herpes zoster, but it occurs very infrequently in children and young adults. PHN occurs in approximately 1 in 5 herpes zoster cases in people aged > 80 years, compared with approximately 1 in 10 cases in people aged 5059 years.4,5,9 The population-based incidence of PHN is 3 times higher in people 7079 years of age than in people 5059 years of age .4

What Are Some Other Side Effects Of Zoster Vaccine

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain, redness, or swelling where the shot was given.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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For Patients Who Do Not Report A Prior Episode Of Varicella

When vaccinating immunocompetent adults aged 50 years and older, there is no need to screen for a history of varicella or to conduct laboratory testing for serologic evidence of prior varicella. More than 99% of adults aged 50 years and older worldwide have been exposed to varicella-zoster virus, and the Advisory Committee on Immunization Practices 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.

For adults 19 years of age and older who are or will be immunocompromised, see .

What If There Is A Serious Problem

An allergic reaction could occur after the vaccinated person leaves the clinic. If you see signs of a severe allergic reaction , call 9-1-1 and get the person to the nearest hospital.

For other signs that concern you, call your health care provider.

Adverse reactions should be reported to the Vaccine Adverse Event Reporting System . Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website at or call . VAERS is only for reporting reactions, and VAERS staff do not give medical advice.

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Conditions Treated By Shingrix And Zostavax

Shingrix and Zostavax are FDA approved to prevent shingles . Both vaccines are indicated to prevent shingles in adults aged 50 years and older. Shingrix and Zostavax are not used to prevent primary varicella infection, also known as chickenpox.

Postherpetic neuralgia is a common type of nerve pain that arises with shingles. Because Shingrix and Zostavax can prevent shingles, they can also prevent postherpetic neuralgia and other painful complications from shingles. However, these vaccines are not labeled to treat PHN.

How Can I Learn More

• Ask your healthcare provider.
• Contact the Centers for Disease Control and Prevention :
• Call 1-800-232-4636 or visit the CDC’s website at

Recombinant Zoster Vaccine Information Statement. U.S. Department of Health and Human Services/Centers for Disease Control and Prevention. 10/30/2019.

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For Patients Who Previously Received Zostavax

Zostavax is no longer available for use in the United States, as of November 18, 2020. Consider the patients age and when he or she received Zostavax to determine when to vaccinate with Shingrix. Studies examined the safety of Shingrix vaccination 5 or more years after Zostavax vaccination. Shorter intervals were not studied, but there are no theoretical or data concerns to indicate that Shingrix would be less safe or effective if administered less than 5 years after a patient received Zostavax.

You may consider an interval shorter than 5 years between Zostavax and Shingrix based on the age at which the patient received Zostavax. Differences in efficacy between Shingrix and Zostavax are most pronounced among older patients. Studies have shown that the effectiveness of Zostavax wanes substantially over time, leaving recipients with reduced protection against herpes zoster. For example, the vaccine efficacy among adults aged 70 to 79 years and adults aged 80 years and older is 41% and 18%, respectively, on average during the first 3 years following Zostavax vaccination.

You should wait at least 8 weeks after a patient received Zostavax to administer Shingrix.

Uncommon Rare And Very Rare Adverse Events

Uncommon adverse events occur in 0.1% to less than 1% of vaccinees. Rare and very rare adverse events occur, respectively, in 0.01% to less than 0.1% and less than 0.01% of vaccinees.

Both HZ vaccines are safe with serious adverse events reported very rarely in immunocompetent individuals.

Recurrence or exacerbation of herpes zoster ophthalmicus following LZV vaccination has been reported very rarely, involving several cases world-wide following LZV immunization. Following a causality assessment of seven cases of HZO which were temporally associated with the administration of LZV, NACI concluded that there was insufficient evidence to recommend for or against the administration of LZV in individuals with a history of HZO. More evidence is required for further assessment of risk related to HZO recurrence in LZV recipients. At this time, there is insufficient evidence to assess the risk related to HZO recurrence following RZV recipients.

See Contraindications and Precautions if considering vaccinating a person with previous HZO.

For more information, refer to Adverse Events Following Immunization in Part 2 and the product monograph in Health Canada’s Drug Product Database.

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A Closer Look At The Safety Data

Both Shingrix and Zostavax shingles vaccines have been shown to be safe and well tolerated. Common side effects, such as soreness and redness at the injection site, are usually mild to moderate in intensity and resolve quickly on their own.

Shingrix

In 8 clinical trials of more than 10,000 participants:

• Grade 3 reactions were common after patients received Shingrix.
• About 1 out of 10 adults who received Shingrix reported grade 3 injection-site symptoms such as pain, redness, and swelling.
• About 1 out of 10 reported grade 3 systemic reactions such as myalgia , fatigue , headache, shivering, fever, and gastrointestinal illness.
• Most people who got Shingrix reported at least some pain at the injection site.

Zostavax

• A 2013 study showed that patients with a history of a previous shingles rash had the same side effects after Zostavax as those with no history of shingles. See Safety of zoster vaccine in elderly adults following documented herpes zoster.

How Well Does Shingrix Work

Two doses of Shingrix provide strong protection against shingles and postherpetic neuralgia , the most common complication of shingles.

• In adults 50 to 69 years old with healthy immune systems, Shingrix was 97% effective in preventing shingles in adults 70 years and older, Shingrix was 91% effective.
• In adults 50 years and older, Shingrix was 91% effective in preventing PHN in adults 70 years and older, Shingrix was 89% effective.
• In adults with weakened immune systems, Shingrix was between 68% and 91% effective in preventing shingles, depending on their underlying immunocompromising condition.

In people 70 years and older who had healthy immune systems, Shingrix immunity remained high throughout 7 years following vaccination.

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Shingles Disease And How To Protect Against It

Shingles, or herpes zoster, is a painful skin rash that develops on one side of the face or body. It is caused by the varicella-zoster virus , the same virus that causes chickenpox. Anyone who has had chickenpox in the past can get shingles because VZV remains in the body after a person recovers from chickenpox. VZV can reactivate many years later, causing shingles.

Shingles is more common in older adults, people who have medical conditions that weaken the immune system, and people who take medications that suppress their immune systems. Getting vaccinated is the best way to prevent shingles.

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How You Get It

A person infected with varicella zoster virus will usually get chickenpox. The disease may be mild or severe. However, it is possible to be infected with the virus and show no symptoms. Once someone has been infected the virus will lay dormant but be kept in check by the bodys immune system. As the immune system weakens the risk of shingles can increase. Certain medications, major surgery, skin burns, HIV, cancer or emotional stress and increasing age can all result in the immune system being weakened. Therefore, it is possible to get shingles with no history of clinical chickenpox. It is also possible to get shingles more than once and again this risk increases with age.

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