Vi2 Herpes Zoster Vaccine Efficacy And Safety In Immunocompromised Or Those On Immunosuppressive Drugs
Although herpes zoster vaccine is not approved for use in immunocompromised patients, off label administration of the vaccine occurs. Several studies have looked retrospectively at the safety of herpes zoster vaccine in groups of patients with underlying autoimmune diseases or receiving immunosuppressant medication. Zhang et al. examined a claims database from Aetna of 44,115 individuals 50 years of age with rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis or inflammatory bowel disease. Of this large population, only 514 patients received herpes zoster vaccine and had also had complete claims history up to 30 days after vaccination. Of these subjects a total of 47 subjects used anti-TNF agents at some time in the 30 days before and 30 days after vaccination. None of these patients developed HZ in the thirty days following vaccination.Footnote 23 In this study, the authors also reviewed low dose immunosuppression with HZ vaccine. Of the 514 persons who received HZ vaccine and had complete claims history, 34 were using methotrexate, 1 was receiving azathioprine, 5 were receiving 6-mercaptopurine, and 48 used oral glucocorticoids. None of these patients developed HZ within one month of vaccination.
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.
Table 5 Quality Rating Of Evidence
Liaison Representatives: Dr. J. Blake , Dr. A. Corriveau , Dr. S. Deeks , Dr. A. Mawle , Dr. D. Moore , Dr. A. Pham-Huy .
Ex-Officio Representatives: Dr. M. Carew , Lt.-Col. P. Eagan , Dr. A. Klein , Dr. B. Law , Dr. B. Raymond , Dr. E. Taylor , Ms. M. St-Laurent .
This statement was prepared by: Dr. O. Baclic, Dr. D. Kumar, and Dr. A. Mah, and approved by NACI.
NACI also gratefully acknowledges the contribution of: Dr. M. Landry, Dr. J. Laroche, Dr. C. Légaré, Dr. S. McNeil, Dr. H. Morrison, Dr. A. Opavsky and Dr. S. Rechner.
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Is The Vaccine Safe
The vaccine can be given to people with a previous history of shingles infection. It should not be given to anyone who currently has shingles. As stated above, the vaccine should not be given to people who are clinically immunosuppressed because the vaccine strain could replicate too much and cause a serious infection. For more information see the MHRA’s Drug Safety Update .
In clinical trials of the vaccine, there have been no reports of someone who was vaccinated passing the virus on to anyone else. However, because the shingles vaccine is a live vaccine, it is thought that this may be possible in rare cases.
There is thought to be a very small risk that someone who has been vaccinated could pass on the virus to someone who is not immune to chickenpox. This is only thought to be a risk if the person who has been vaccinated develops a shingles type rash at the injection site or elsewhere on the body.
The shingles vaccine is not recommended for pregnant women as a matter of caution. However, studies have been carried out on pregnant women who have accidentally received chickenpox or shingles vaccines. These have not shown any link between the weakened virus in the vaccine and any specific problems in babies born to these women. See this Public Health England statement for more information.
What Should I Advise Patients Who Cannot Receive Zostavax But Are Worried About Developing Shingles Disease
The reason immunosuppressed patients cannot receive Zostavax® despite an increased risk of infection is that the live-attenuated Zostavax® strain can itself cause an infection. Fatal cases of disseminated vaccine strain infection have been reported, noting that Zostavax® is a 14-fold higher titre, than the varicella live-attenuated vaccine.
Antiviral treatments are available for patients who develop shingles.
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New Shingles Vaccine: What You Need To Know
Nov. 13, 2019 — Unlike some vaccines, thereâs been so much demand for the new shingles vaccineShingrix that itâs not always easy to find. It was approved in 2017, and the CDC recommends the vaccine for adults 50 and older to prevent this painful, blistering illness. It is being used in place of the previous vaccine, Zostavax.
More than a year later, doctors say they are learning more about how it works, its safety risks, and how it compares to Zostavax.
How effective is Shingrix?
âIt’s just remarkable,” says Wilbur Chen, MD, an associate professor of medicine at the Center for Vaccine Development and Global Health, University of Maryland School of Medicine. “It has performed better than I expected.”
In studies, Shingrix was more than 97% effective at preventing shingles in people 50 and older. It works just as well in older adults, who are at greater risk for a painful shingles complication called postherpetic neuralgia . “When 70- and 80-year-olds get shingles, it can be extremely debilitating,” Chen says.
By contrast, Zostavax cuts the risk of shingles by only 51% and PHN by 67%. It’s only about 38% effective in people over age 70.
How safe is Shingrix?
“So far so good,” Schaffner says. The main side effect is soreness in the arm where you get the shot.
Other side effects are mild and usually last for 2 to 3 days, including:
- Stomach pain
Who shouldn’t get Shingrix?
Can I get the Shingrix vaccine now?
How do I pay for Shingrix?
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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Do I Need To Pay For Shingles Immunisation
Vaccines covered by the NIP are free for people who are eligible. See the NIP Schedule to find out which vaccines you or your family are eligible to receive.
Eligible people get the vaccine for free, but your health care provider may charge a consultation fee for the visit. You can check this when you make your appointment.
If you are not eligible for free vaccine, you may need to pay for it. The cost depends on the type of vaccine, the formula and where you buy it from. Your immunisation provider can give you more information.
When Should You Get Immunised Against Shingles
Anyone aged 60 years and over who wants to protect themselves against shingles can talk to their doctor about getting immunised.
Shingles immunisation is recommended for:
- adults aged 60 years and over who have not previously received zoster vaccine
- adults aged 70 years to 79 years, for free under the National Immunisation Program
- adults aged 50 or over who live in the same household as someone who has a weakened immune system.
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Vii Coadministration Of Herpes Zoster Vaccine With Pneumovaxtm23
In the previous statement, NACI recommended separating herpes zoster vaccine and PneumovaxTM23 administration by a minimum of 4 weeks. These recommendations were based on the paper from MacIntyre et al. that found lower VZV GMT at four weeks following simultaneous administration of ZostavaxTM and PneumovaxTM 23.Footnote 28
How Is Zoster Vaccine Given
Zoster vaccine is given as an injection under the skin. You will receive this vaccine in a doctor’s office or other clinic setting.
Zoster vaccine is usually given as a one-time injection. Unless your doctor tells you otherwise, you will not need a booster vaccine.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
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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.
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 Vaccine Safety in Part 2.
For more information refer to Reporting Adverse Events Following Immunization in Canada.
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Does Shingrix Cause Guillain
In March 2021, the FDA required safety label changes for Shingrix warning of the risk for Guillain-Barré Syndrome following administration of Shingrix. In an observational study, an increased risk of GBS was found during the 42 days following vaccination with Shingrix. The FDA has not determined if the cause of GBS was due to Shingrix, only that there was an association.
Guillain-Barré syndrome is a rare disorder in which the bodys immune system damages nerve cells, causing muscle weakness and sometimes paralysis
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This is not all the information you need to know about Shingrix and Zostavax for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full product information, and discuss this information and any questions you have with your doctor or other health care provider.
Herpes Zoster In Australia
In Australia, there are about 560 cases of herpes zoster per 100,000 population per year in all age groups.49
In comparison, there are about 1174 cases per 100,000 population in people aged 50 years.49 Herpes zoster incidence increases with age, from an estimated rate of 630 per 100,000 population in people aged 5059 years, to 1531 per 100,000 population in people aged 7079 years.49
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Why A New Shingles Vaccine
Did we need a new shingles vaccine? To answer that question, it helps to have a bit of background on this infection.
Shingles, which is also called herpes zoster, occurs when the chickenpox virus , which is dormant in those whove had the illness, reawakens later in life. Almost all adults older than 40 carry the chickenpox virusand the older we get, the more the risk of getting shingles climbs. According to the CDC, the infection strikes about 1 million people in the U.S. each year and nearly one in three adults will experience a bout of shingles in their lifetime.
The two to four weeks of shingles, marked by symptoms such as a blistery and painful rash on one side of the body, can be difficult enough. But about one in five people with shingles go on to develop postherpetic neuralgia, or PHN, which is nerve pain that can linger for months or even years.
Since 2006, weve had Zostavaxapproved for those between 50 and 59 but recommended by the CDC for adults 60 and olderas the sole bulwark against shingles. Zostavax offers 70 percent protection against shingles for people between 50 and 59 but only 18 percent in people 80 and older, according to the Pink Sheet, which reports on the pharmaceutical industry.
When all ages are taken into consideration, Zostavax cuts the chance of shingles by only 51 percent and the risk of PHN by 67 percent.
Shingles is a big problem with immunocompromised people, Schaffner says.
How Long Should I Wait After Chemotherapy Or Radiotherapy Before Vaccinating A Patient
Patients should wait at least 6 months after the end of treatment and after patients are demonstrated to be in remission before considering immunisation with Zostavax®. The timeline will be different for patients following an allogeneic transplant, refer to the Australian Immunisation Handbook for further information.
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Shingrix Vs Zostavax: How Do Various Shingles Vaccines Stack Up
Its important to understand what shingles is. Shingles is essentially a reactivation of chickenpox. Chickenpox is a bit of a misnomer. The pox ending refers to its blistering rash. For much of human history it was thought to be similar to smallpox . However, the two infections are entirely unrelated.
Why it was called chicken-pox is not entirely clear since the disease has nothing to do with chickens. A few theories have been put forward. One is that chicken-pox is a linguistic corruption of child-pox since the disease generally affects children. But the real reason is likely lost to history. In any case, we are better off referring to chickenpox by its scientific name of varicella.
Varicella is caused by the aptly named Varicella-zoster virus . Varicella is not a benign illness and it can be fatal, but most people survive the initial infection. However, even though the characteristic rash eventually disappears, the virus is never entirely cleared from the human body. It remains dormant in the dorsal root ganglia, a cluster of nerve cells that run parallel to the spine. Your immune system normally keeps the virus in check. But as we age, immunity can wane. By age 55, 30-40% of people have lost the specific immunity they had to the varicella-zoster virus and the virus can re-awaken.
Warnings Of Shingrix And Zostavax
Shingrix and Zostavax can cause hypersensitivity, or allergic, reactions in those with allergies to vaccine ingredients. Zostavax may cause severe allergic reactions in those with a known allergy to gelatin or neomycin. Severe allergic reactions can lead to severe rash and trouble breathing .
Zostavax should be avoided in those who take immunosuppressive agents and those who are affected by medical conditions that weaken the immune system.
Ask your doctor or pharmacist about other precautions before getting a shingles vaccine.
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For What Patient Groups Is Zostavax Contraindicated
Zostavax® is contraindicated for patients who are anaphylactic to any component of a VZV-containing vaccine or previous doses of a VZV-containing vaccine. Zostavax® is also contraindicated in patients who are immunocompromised either due to a medical condition or due to medical treatment and medication. It should not be given in pregnancy.
If there is uncertainty about a patients level of immunocompromise and whether vaccination is contraindicated, best practice is to delay vaccination until expert advice can be sought. The Australian Immunisation Handbook: Table. Live shingles vaccine screening for contraindications should be used for all patients presenting for Zostavax® vaccine prior to administration to assist in the identification of patients who may be contraindicated for the shingles vaccine.
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.50,51
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
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British Columbia Specific Information
Shingles is a painful rash caused by the varicella zoster virus. The shingles vaccine is the best way you can protect yourself against the virus. For more information about the shingles vaccine, see HealthLinkBC File #111 Shingles Vaccine or visit the ImmunizeBC Shingles web page.
Shingles is a viral infection of the nerve roots that occurs when the virus that causes chickenpox starts up again in your body. There are two shingles vaccines approved for use in Canada.
What Systems Will Help Ensure The Zoster Vaccine Is Used Safely
Always check the AIR and patient medical records prior to considering vaccine administration. The pre-immunisation checklist, and the Australian Immunisation Handbook: Table. Live shingles vaccine screening for contraindications should also be completed before administration.
If in doubt, delay vaccination until further information/expert advice can be obtained.
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