Wednesday, September 27, 2023

Is Recombinant Zoster Vaccine The Same As Shingrix

Financial And Insurance Assistance

Shingles Vaccine Meets Unprecedented Demand

If you need financial support to pay for Shingrix, help is available.

GlaxoSmithKline Biologicals, the manufacturer of Shingrix, offers a program called GSKforyou. For more information and to find out if youre eligible for support, call 866-728-4368 or visit the program website.

Besides Shingrix, Zostavax is the only other vaccine thats available to help prevent shingles. Here we look at how Shingrix and Zostavax are alike and different.

Shingrix Shingles Vaccine Indication

Shingrix is a non-live vaccine for preventing shingles in adults 50 years and older. If you’re one of the 99% of adults over 50 years old who have had chickenpox, the virus that causes shingles is inside your body and can reactivate at any time. Shingrix is not used to prevent primary varicella infection .

The US Food and Drug Administration approved Shingrix on July 26, 2021, to prevent shingles in adults aged 18 years and older who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. However, for adults who are or will be immunodeficient or immunosuppressed due to known disease or treatment and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose.

GSK says people should not receive Shingrix if they are allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix. And, Shingrix was not studied in pregnant or nursing women. So tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding, says GSK.

Complications can arise with Shingles, especially in older adults. However, the National Insitute on Aging says ‘the shingles vaccine is safe and easy, and it may keep you from getting shingles and ongoing pain called postherpetic neuralgia, or PHN. Healthy adults age 50 and older should get vaccinated with a shingles vaccine called Shingrix.’

Prevention Of Herpes Zoster

Prevention of herpes zoster in adults 50 years of age.

Zoster is caused by reactivation of latent VZV infection in individuals who previously had varicella infection. An estimated 500,000 to 1 million cases of zoster occur each year in the US many patients develop postherpetic neuralgia and require long-term management for refractory PHN. Risk of developing zoster increases with age and declining cell-mediated immunity to VZV. Zoster occurs principally in individuals > 45 years of age estimated lifetime risk of zoster is 32%, and 50% of individuals living until 85 years of age will develop zoster.

Zoster vaccine recombinant is used to boost active immunity to VZV, thereby reducing risk of VZV reactivation. May also reduce frequency and/or duration of PHN in those who develop zoster despite vaccination.

Not indicated for treatment of zoster or PHN. Do not administer during an acute episode of zoster. Has no role in postexposure management of zoster.

Not indicated for prevention of primary varicella infection do not use in children or adults < 50 years of age. Has no role in postexposure management of chickenpox.

There are 2 different types of zoster vaccine commercially available in the US for immunization against zoster in adults 50 years of age: zoster vaccine recombinant and zoster vaccine live .

For prevention of zoster in immunocompetent adults 60 years of age, ACIP states that either zoster vaccine recombinant or zoster vaccine live can be used.

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What If I Wait Too Long To Take The Second Dose Will I Need To Restart The Vaccination Process

The Centers for Disease Control and Prevention states that if more than six months have passed since you received your first dose, you should get the second dose as soon as possible. You dont have to start the doses all over again.

Also, if you get the second dose within four weeks after the first dose, it should not be counted. You should get the follow-up dose at least two months after the first dose.

For Patients Who Previously Received Zostavax

Shingles (Herpes Zoster)

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 five 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 five years after a patient received Zostavax.You may consider an interval shorter than five 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 age 70 to 79 years and adults age 80 years and older is 41% and 18%, respectively, on average during the first three years following Zostavax vaccination.You should wait at least 8 weeks after a patient received Zostavax to administer Shingrix.

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Zoster Vaccines In Immunocompromised Populations

Although antiviral treatments are available for HZ, prevention of HZ by vaccination is of importance to immunocompromised patients because they are at increased risk for HZ and severe complications , and even early antiviral therapy does not prevent the development of PHN. The ACIP recommends administration of ZVL or RZV to persons taking low-dose immunosuppressive therapy , persons anticipating immunosuppression, and patients who have recovered from an immunocompromising illness . Immunocompromised persons and those on moderate to high doses of immunosuppressive therapy were excluded from the SPS and ZOE-50/70 efficacy trials . On July 23, 2021 the FDA approved SHINGRIX for the prevention of HZ in adults 18 yoa who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy .

How Safe Is Shingrix

The FDA has approved Shingrix for preventing shingles in adults ages 50 and older. The results of several studies showed that Shingrix was safe and effective.

There have been concerns about ingredients, such as thimerosal, that may be added to vaccines. Thimerosal is a kind of preservative that contains mercury. Its added then taken out of some vaccines to keep other germs and bacteria from growing. The concern arose when early research connected thimerosal to autism. This link has since been found to be false. Shingrix doesnt contain thimerosal.

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What Everyone Should Know About The Shingles Vaccine

Shingles vaccination is the only way to protect against shingles and postherpetic neuralgia , the most common complication from shingles. CDC recommends that healthy adults 50 years and older get two doses of the shingles vaccine called Shingrix , separated by 2 to 6 months, to prevent shingles and the complications from the disease. Your doctor or pharmacist can give you Shingrix as a shot in your upper arm.

Shingrix provides strong protection against shingles and PHN. Two doses of Shingrix is more than 90% effective at preventing shingles and PHN. Protection stays above 85% for at least the first four years after you get vaccinated.

Shingles Causes And Symptoms

How Can You Prevent Shingles

Also known as herpes zoster, singles is a viral infection caused by a reactivation of the varicella zoster virus . The disease results in a painful and itchy rash that develops on one side of the body and can last for two to four weeks.

A person affected by shingles may feel postherpetic neuralgia pain ranging from three months to several years, even after the virus is no longer active. PHN may occur in between 10% and 18% of all shingles cases.

The disease generally occurs in older people, whose weakened immune systemsare unable to maintain a resilient and effective response to VZV reactivation.

Symptoms include pain, burning, numbness, and tingling, as well as sensitivity to touch, fluid-filled blisters, and itching.

An estimated one million cases of shingles are reported a year in the US, while the disease affects approximately 130,000 people a year in Canada.

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How Long Does It Take To Work

It takes time for your body to make enough antibodies to fight off germs and protect you from certain diseases.

Results from clinical studies of Shingrix showed that the recommended dosing schedule for Shingrix does cause an immune response. This dosing schedule states that after you receive the first dose, you should get the second dose two to six months later.

How long Shingrix takes to work may not be the same for everyone. The timing for you will depend on your body chemistry. In general, you should be protected from shingles soon after the second dose.

Dose Route Of Administration And Schedule

Live attenuated zoster vaccine


Each dose is 0.65 mL .

Route of administration

Each dose is 0.5 mL .

Route of administration

Intramuscular, into the deltoid region of the upper arm.

Administration of the RZV as a subcutaneous injection is a vaccine administration error and should be avoided. However, if Shingrix is inadvertently administered subcutaneously, that dose will be considered as valid in the vaccine series. The second dose will be given as per vaccine schedule.

For more information, refer to Vaccine Administration Practices in Part 1.


2 doses, 2 to 6 months apart. A 0,12 months schedule may be considered for improved adherence to the 2nd dose .

Providers should consider different strategies to promote adherence to the two dose schedule for RZV .

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Administration With Other Vaccines

CDC general recommendations advise that recombinant and adjuvanted vaccines, such as Shingrix, can be administered concomitantly, at different anatomic sites, with other adult vaccines. Concomitant administration of Shingrix with Fluarix Quadrivalent has been studied, and there was no evidence for interference in the immune response to either vaccine or safety concerns. Evaluation of co-administration of Shingrix with 23-valent pneumococcal polysaccharide vaccine and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed is ongoing. The safety and efficacy of administration of two adjuvanted vaccines , either concomitantly or at other intervals, have not been evaluated.

Shingrix and pneumococcal vaccine may be administered at the same visit if the person is eligible for both. When both pneumococcal conjugate vaccine PCV13 and PPSV23 are recommended for an adult, PCV13 should always be administered first and may be administered concomitantly with Shingrix.

Can Shingles Be Prevented

Postlicensure Safety Surveillance of Recombinant Zoster ...

The only way to reduce the risk of developing shingles or PHN is to get vaccinated.

The new recombinant zoster vaccine, Shingrix, and the zoster vaccine live, Zostavax, are both approved by the Food and Drug Administration to prevent shingles for most adults age 50 and older.

The CDC recommends that healthy adults 50 years and older get two doses of the Shingrix vaccine to protect against shingles and its potential complications. The vaccine is available in pharmacies and doctors offices.

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Is Shingrix Or Zostavax Better

Shingrix is more effective than Zostavax. Shingrix is 97% effective at preventing shingles in adults aged 50 to 69 years old whereas Zostavax is only 70% effective at preventing shingles in the same age group. Shingrix consistently prevents shingles in older adults while the effectiveness of Zostavax decreases with increasing age. However, Shingrix has more systemic side effects than Zostavax.

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 Vaccine safety in Part 2 and the product monograph in Health Canada’s Drug Product Database.

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Shingrix Shingles Vaccine Side Effects And Warning

COVID-19 vaccines may be administered without regard to the timing of other vaccines, stated the CDC on September 15, 2021. This includes simultaneous administration of the COVID-19 vaccine and other vaccines on the same day. However, it is not known if the reactogenicity of COVID-19 vaccines increased with coadministration, including with other vaccines known to be more reactogenic, such as adjuvanted vaccines, including certain flu shots.

Previously, the CDC stated ‘You should wait a minimum of 14 days after administering the mRNA COVID-19 vaccine series to give a patient Shingrix. Alternatively, if a patient just received Shingrix, you should wait a minimum of 14 days before giving them the mRNA COVID-19 vaccine series.’

Healthcare providers should defer vaccination for patients with suspected or confirmed COVID-19, regardless of symptoms, until the patient has met the criteria for discontinuing isolation, says the CDC.

The U.S. FDA Safety Communication issued a notice on March 24, 2021, to inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix based on post-marketing experience. The revised label includes Guillain-Barré Syndrome in the “Warnings and precautions” section.

Talk With Your Health Care Provider

Zoster Vaccine in Rheumatic Disease: Dr. David Liew

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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Recombinant Subunit Herpes Zoster Vaccine

A subunit vaccine containing recombinant VZV gE and the AS01B adjuvant system was developed by GlaxoSmithKline Vaccines . Varicella-zoster virus gE is the most abundant glycoprotein in VZV virions and infected cells it is essential for virus replication and cell-to-cell spread, and it is a major target for VZV-specific CD4+ T-cell responses . The liposome-based AS01B adjuvant system contains 2 immunostimulants: monophosphoryl lipid A, a TLR4 agonist that stimulates NF-B transcription and cytokine production and activates antigen-presenting cells and QS-21, a natural saponin that promotes antigen-specific antibody and CD4+ T-cell responses .

Two randomized, placebo-controlled phase III efficacy trials were conducted concurrently in 18 countries in North America, Europe, Asia, Australia, and Latin America to determine the safety and efficacy of RZV against HZ and PHN in adults 50 yoa . Recombinant zoster vaccine efficacy for incidence of HZ was 97.2% in adults 50 yoa and 89.8% in adults 70 yoa . In an analysis of pooled data from subjects 70 yoa in ZOE-50 and ZOE-70 , RZV efficacy was 91.3% for incidence of HZ and 88.8% for incidence of PHN. In both ZOE-50 and ZOE-70, RZV efficacy for incidence of HZ did not decrease significantly with increasing age and remained high after a mean follow-up of 3.7 years.

Persistence of Recombinant Zoster Vaccine Efficacy

What If Im Not Sure If Ive Had Chickenpox

First, know that almost everyone born before 1980 tests positive for exposure to Varicella zoster, the virus that causes chickenpox and reactivates later to cause shingles. All published recommendations suggest that whether you remember having chickenpox or not, you should receive the Shingles vaccine, either Zostavax or Shingrix.

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Shingrix For Prevention Of Shingles

Shingrix is a vaccine thats used to prevent shingles in adults ages 50 and older. Its not approved for use in adults younger than 50. Also, its not meant for use in preventing chickenpox .

Effectiveness for prevention of shingles

Shingrix has been found to be effective in helping to prevent shingles. For details on how the drug performed in clinical studies, see Shingrixs prescribing information.

Conditions Treated By Shingrix And Zostavax

Shingles Online and Print Materials

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.


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Shingrix Vs Zostavax: Differences Similarities And Which Is Better For You

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There are currently two vaccines that can be given to prevent herpes zoster, more commonly known as shingles: Shingrix and Zostavax. A shingles vaccine is recommended for adults once they turn 50.

Most people have been infected with the varicella zoster virus if theyve ever had chickenpox. After chickenpox resolves, the varicella zoster virus lies dormant in the body for years, if not forever. Later in life, the virus can reactivate as shingles and cause a painful rash that usually wraps around the face or torso.

Although Shingrix and Zostavax work in similar ways to prevent shingles, there are some important differences between the two.

New Shingles Vaccine Over 90% Effective

Shingles is a painful rash on the skin that comes from the same virus that causes chickenpox.

Recently, shingles has made headlines because of a new vaccine that was approved in 2017: the recombinant zoster vaccine, or Shingrix.

According to the Centers for Disease Control and Prevention , two doses of the new vaccine are more than 90 percent effective at preventing shingles and its side effects.

Shingles is a painful, often debilitating rash that affects roughly 1 million people each year. Luckily, getting vaccinated can help you prevent it and stop shingles from spreading.

To help explain more about how shingles spreads and what it is, weve gathered key information from MedlinePlus and the National Institute of Neurological Disorders and Stroke.

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