Outcome Definitions And Follow
Our primary outcome was community HZ, defined by a claim in the OP or PB setting with an International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code for HZ in any position with a claim for HZ-specific antiviral , identified using NDCs, within 7 days of diagnosis. As a sensitivity analysis, we used this same clinical definition without requiring a prescription for antivirals. As secondary outcomes, we evaluated community ophthalmic zoster and PHN. We defined community OZ by a claim in the institutional OP or PB setting with an ICD-10 diagnosis code for OZ in any position , combined with a claim for a prescription for HZ-specific antivirals within 7 days of diagnosis. We defined PHN in the 90180 days after HZ onset using a modified version of the PHN algorithms from Klompas et al and Klein .
Follow-up continued until occurrence of any of the following: a subsequent claim for a third dose of RZV death termination of Medicare Parts A/B or D coverage or enrollment into Part C admission to a nursing home, skilled nursing facility or hospice occurrence of either HZ, OZ, or PHN or end of the study period.
Very Common And Common Adverse Events
Very common adverse events occur in 10% or more of vaccinees. Common adverse events occur in 1% to less than 10% of vaccinees.
Injection site reactions are very commonly reported for both LZV and RZV. For LZV recipients the frequency is slightly higher in adults aged < 60 years. For all ages, the majority of these events were rated mild or moderate in intensity and lasted less than 2 days.
Due to the adjuvant in RZV, which induces a high cellular immune response and helps address the natural age-related decline in immunity, RZV is more reactogenic than LZV.
Injection site AEs are very commonly reported by recipients of RZV. Approximately 80% report injection-site pain and approximately 30% report redness at the site of injection.
Systemic adverse events, primarily fatigue and myalgia are common in LZV recipients and very common in RZV recipients . For RZV, they include headache .
Local and systemic reactions that were severe enough to interfere with normal activities have been more frequently reported following the receipt of RZV than LZV. However, these reactions have been temporary . Patient education on the short-term reactogenicity of the RZV is recommended prior to vaccine administration to promote adherence to the second dose.
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.
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.
Studies in animals showed that there was no risk with Shingrix during pregnancy. However, animal studies dont always predict the way humans would respond.
If youre pregnant or planning to become pregnant, wait until after youve had your baby to get the Shingrix vaccine. Talk with your doctor if you have any concerns.
There havent been enough studies to show whether Shingrix appears in breast milk.
Until more is known, its best to wait until youve finished breastfeeding before getting Shingrix.
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Can You Get Shingles After Youve Been Vaccinated
While the shingles vaccine is highly effective, some people can still get shingles. However, people who do get shingles after getting the shingles vaccine usually have milder symptoms and a shorter illness. Youll also be less likely to have complications from shingles, including postherpetic neuralgia.
Coverage And Cost Comparison Of Shingrix Vs Zostavax
For adults aged 50 years and older, only plans with Medicare Part D coverage will cover the Shingrix vaccine. However, there may still be a copay even with Medicare Part D coverage. The average cash price for one Shingrix dose is $167, though you may be able to use a prescription discount card to lower this cost. Check with your local pharmacy to see if you can use a Shingrix SingleCare card.
Like Shingrix, Zostavax is primarily covered by Medicare Part D plans or Medicare Advantage plans with Medicare Part D coverage. The copay for Zostavax with insurance can vary. With an average cash price of $278, Zostavax can be expensive with or without insurance. Using a prescription discount card for Zostavax may be able to reduce this cost.
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*not reportedFrequency is not based on data from a head-to-head trial. This may not be a complete list of adverse effects that can occur. Please refer to your doctor or healthcare provider to learn more.Source: DailyMed , DailyMed
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Shingrix Is Not A Live Vaccine
A live vaccine is one that contains a weakened form of a germ. Shingrix is not a live vaccine. Its an inactive vaccine, which is a vaccine thats made from a germ thats been killed.
Because Shingrix is inactive, more people can receive it. This includes people with a weakened immune system .
People with weakened immune systems are typically advised against receiving live vaccines. This is because on very rare occasions, live vaccines can mutate back to the full-strength germ that causes a disease.
If this happens, people with weakened immune systems would have a much higher risk for developing the disease that the vaccine is meant to prevent.
Shingrix is also a recombinant vaccine. This means that its made of parts of the shingles virus, such as protein, sugar, or capsid .
There used to be an alternative shingles vaccine to Shingrix. This other vaccine was called Zostavax.
Like Shingrix, it was approved to prevent shingles . However, Zostavax is
Below, we briefly describe the similarities and differences between these two vaccines.
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.
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When To See A Healthcare Provider
For most people, the effects of Shingrix are mild and short-term. In very rare cases, Shingrix can cause more serious side effects.
Seek urgent medical care if you experience signs of a severe allergic reaction a few minutes or hours after your second dose of Shingrix, such as:
- Rapid heartbeat
- Facial swelling
- Swelling in the throat or mouth
You should also let your healthcare provider know if your Shingrix side effects are severe or arent going away on their own.
When Should I Get The Second Dose
The CDC recommends that adults ages 50 and older get a second dose of Shingrix two to six months after their first dose. If youve waited longer than six months since your first dose of Shingrix, its safe to get a second dose right away. Most people dont need to repeat the first dose.
Some immunocompromised adults may need a second dose within one to two months. If you have a disease or are taking medication that affects your immune system, talk to your healthcare provider about the best timeline for your two doses of the shingles vaccine.
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What Are The Possible Side Effects Of Shingles Immunisation
All medicines and vaccines can have side effects. Sometimes they are serious, most of the time theyre not.
For most people, the chance of having a serious side effect from a vaccine is much lower than the chance of serious harm if you caught the disease.
Talk to your doctor about possible side effects of shingles vaccines, or if you have possible side effects that worry you.
Common side effects of shingles vaccines include:
- pain, redness, swelling or itching where the needle went in
Serious reactions to immunisation are rare. With Zostavax® vaccination, very rarely a generalised chickenpox-like rash may occur around 24 weeks after vaccination. This may be associated with fever and feeling unwell. This rash may be a sign of a serious reaction to the virus in the vaccine. Seek medical attention and inform of recent Zostavax vaccination if you experience this reaction.
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How Safe Is Shingrix
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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More Information On Side Effects
Reactions listed under possible side effects or adverse events on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.
If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency through the Yellow Card Scheme . See more information on the Yellow Card scheme and monitoring of vaccine safety.
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Is The Shingles Vaccine Safe
As with any vaccine, its possible to have some side effects after receiving it. In clinical studies, the side effects linked to this vaccine usually lasted only 2 to 3 days, and the most common ones were:
-
Pain and redness at the injection site
Most people report at least some arm pain after the injection. Some people reported that their side effects kept them from doing their usual daily activities. For this reason, its a good idea to plan to not do anything right after receiving your injection, just in case.
Severe allergic reaction to this vaccine is very rare. Symptoms of such a reaction include:
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How Can I Get The Shingles Vaccine
You can buy the shingles vaccine at most pharmacies and travel clinics. Shingrix® is given as a series of 2 doses, 2 to 6 months apart, and costs about $150/dose. Zostavax® II is given as 1 dose and costs about $200. Some health insurance plans may cover the cost of the vaccine check with your provider.
If you buy the vaccine at a travel clinic, a doctor or nurse on site will be able to immunize you. Most pharmacists in B.C. are also able to immunize.
If you want to be immunized by your doctor, find out if they have a supply of the shingles vaccine.
Redness At Injection Site
Redness at and around the injection site is common and may appear immediately or some days after receiving Shingrix. This redness commonly develops due to a localized immune system response, which shouldnt cause further concern.
Arm redness should disappear within a few days after receiving the vaccine. However, if you experience redness with a rash or severe pain, let your doctor know as soon as possible.
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What If I Wait Too Long To Take The Second Shingrix Dose
The Centers for Disease Control and Prevention state that if more than 6 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 4 weeks after the first dose, it should not be counted. You should get your follow-up dose at least 1 to 2 months after the first dose, per your doctors recommendation.
Why Do I Need Two Doses Of Shingrix
In addition to a painful rash, shingles can lead to serious health complications like PHN, pneumonia, vision loss, hearing problems, and encephalitis . Research indicates that about 1% to 4% of people with shingles will be hospitalized.
Two doses of Shingrix offer effective protection against shingles and related complications for at least seven years. Among healthy adults ages 50-69, Shingrix is more than 90% effective in preventing PHN when two doses are administered. Among adults ages 70 and older, it is 89% effective.
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When Should You Get Vaccinated Against Shingles
Most people should be vaccinated against shingles at ages 50 and over. People ages 18 and over who have health conditions or take medications that can weaken the immune system should consider getting the shingles vaccine before age 50.
For people receiving the vaccine at ages 50 and over, there is no particular time and no maximum age when you should be vaccinated.
Vaccination against shingles can be done on its own or alongside other vaccinations, like for the flu or pneumonia. Generally, the vaccine is given in two doses, with the second dose given 2 to 6 months after the first dose.
For people who are receiving the shingles vaccine because of an immune deficiency, the second dose can be given sooner: 1 to 2 months after the first dose.
In this case, if possible, shingles vaccination should be timed with your immune response. This could mean waiting until after a flare-up of your condition has subsided or getting the vaccine before you receive certain immune-suppressing medications.
7 years and remains effective afterward.
Speak with a doctor about how often you should be vaccinated for shingles based on your specific immune system and health concerns.
The shingles vaccine that is currently available in the United States was introduced in 2017, so you may have questions about it. Below are answers to some of the most common questions.
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.
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What Does The Shingles Vaccine Do
The shingles vaccine can prevent shingles. Every year, about 1 million people in the United States get shingles. Anyone whos had chickenpox can get shingles. Thats because the varicella-zoster virus lives silently in your nervous system after you’ve had chickenpox. The virus can reactivate later in your life if your immune system is weakened. Your risk of getting shingles goes up as you get older. In the United States, 1 in 3 people will get shingles in their lifetime.
Cdc Recommendation For The Shingles Vaccine
The Centers for Disease Control and Prevention recommend Shingrix as the preferred vaccine to prevent shingles and other complications from the disease.
The CDC found that Shingrix was more effective than Zostavax. It recommends that you receive Shingrix, even if youve had Zostavax in the past.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.
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Pain At Injection Site
Pain at the injection site is a common side effect of many vaccines, including Shingrix. This pain is generally mild but can feel like anything from slight discomfort to deep bruising. In some cases, injection site pain can be severe enough to limit arm movement.
To ease this discomfort, you can apply cold packs to the affected area for 20 minutes at a time.
If these arent effective, over-the-counter pain remedies may help. However, if you have injection site pain that is severe or lasts longer than 2 to 3 days, follow up with your doctor.