Can It Cause Side Effects
Like every vaccine, Shingrix has the potential for side effects, although so far, none seem particularly worrisome. The new shingles vaccine does appear to be more likely to cause pain during injection and at the site of injection for up to three days afterward than Zostavax does.
In clinical trials, the side effects also included injection site redness and swelling, muscle pain, and immune system responses such as headache, shivering, fever, and upset stomach. Most, according to GlaxoSmithKline, its manufacturer, lasted less than three days.
Though Shingrix was tested on some 16,600 adults in clinical trials, its real-world use has been limited. The company will be conducting additional safety and efficacy studies over the next few years, and the CDC will be monitoring any adverse events that are reported.
As with any drug thats approved on the basis of studies in only thousands, in contrast to millions after approval, strict post-marketing surveillance studies have to be agreed upon, with severe penalties for irregularities, says CRs Lipman.
What Is The Shingles Vaccine
The shingles vaccine can protect you against shingles and postherpetic neuralgia , which is the most common complication of shingles. Shingles is a painful rash caused by the varicella-zoster virus, the same virus that causes chickenpox. The rash usually develops on one side of your body or face. It starts with red bumps and then the bumps turn into fluid-filled blisters.
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.
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What Is The Brand Name Of The Shingles Vaccine
There are 2 shingles vaccines used in the UK:
- Zostavax, a live vaccine given as 1 dose
- Shingrix, a non-live vaccine given as 2 doses, 2 months apart
Most people will have the Zostavax vaccine. The Shingrix vaccine is recommended if Zostavax is not suitable for you, for example if you have a condition that affects your immune system.
You can read more about the shingles vaccines in the patient information leaflets:
What Are The Main Differences Between Shingrix And Zostavax
Shingrix is a recombinant, adjuvanted zoster vaccine that was first FDA-approved in 2017. It uses the varicella-zoster glycoprotein E antigen to produce an immune response in the body. An adjuvant, or added ingredient, helps boost the bodys immune response to the virus. Because Shingrix is an inactivated vaccine, it can be used in immunocompromised patients or those with a weakened immune system.
Shingrix is administered as an injection into the muscle . It is given in two separate doses with a period of two to six months in between. The second dose is necessary to ensure long-term effectiveness.
Zostavax, approved in 2006, is a live attenuated herpes zoster vaccine. In other words, Zostavax contains a weakened version of the actual virus to produce an immune response. For this reason, it is not recommended for those who are immunocompromised. Or else, the vaccine itself could cause an infection.
Zostavax is administered as a single injection underneath the skin . It comes in a frozen version and a refrigerator-stable version. The frozen version must be kept frozen during transport and storage to ensure its effectiveness while the refrigerator-stable Zostavax can be kept in a refrigerator until it needs to be used.
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More Common Side Effects
The more common side effects of Shingrix can include:
- pain, redness, and swelling at site of injection*
- dizziness or fainting
- flu-like symptoms, including fever, shivering, and tiredness
Most of these side effects may go away within a few days or a couple of weeks. If theyre more severe or dont go away, talk to your doctor or pharmacist.
* For more information about this side effect, see Side effect details below.
How Is Shingrix Given
Shingrix is given as an injection into a muscle. A healthcare provider will give you this injection.
Shingrix is usually given in a series of 2 shots:
the second shot may be given any time within 2 to 6 months after the first shot.
for people who have a weak immune system, the second shot may be given any time within 1 to 2 months after the first shot.
You may receive this vaccine at the same time that you get a flu shot.
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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Mayo Clinic Q And A: New Shingles Vaccine Recommended For Most Adults Over Age 50
DEAR MAYO CLINIC: How effective is the shingles vaccine? Who should get it? Is it recommended even for those who have already had shingles?
ANSWER: A new vaccine, called Shingrix, is now available thats very effective in preventing shingles. The Centers for Disease Control and Prevention recommends that everyone age 50 and older with a healthy immune system receive this vaccine, whether youve had shingles before or not.
Unlike the other vaccine thats been available for shingles since 2006, called Zostavax, this new vaccine is inactivated. That means it does not contain a live virus. Because of that, it is safe in people who have weakened immune systems. However, the CDC has not yet made recommendations for Shingrix vaccination in these individuals. If you have a weakened immune system, talk to your health care provider about your vaccination options for shingles.
Shingles is caused by a virus called varicella-zoster. When youre first infected with this virus, it causes the itchy rash known as chickenpox. Although chickenpox is uncomfortable, most people recover from it without any lasting problems. But after the rash of chickenpox goes away, the virus does not. Instead, the varicella-zoster virus goes into hiding in your bodys nerve cells.
Side Effects And Counseling For Reactogenicity
In eight clinical trials of more than 10,000 immunocompetent participants 50 years or older, 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. Also, 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.
Local and systemic grade 3 reactions among immunocompromised adults were evaluated in six studies in five immunocompromised groups. Local grade 3 reactions occurred in 10.7% to 14.2% of RZV recipients, and systemic grade 3 reactions occurred in 9.9% to 22.3% of RZV recipients, compared with 0% to 0.3% and 6.0% to 15.5%, respectively, among placebo recipients. The most commonly reported systemic symptoms were fatigue and myalgia.
Healthcare providers should counsel patients about expected reactogenicity before administering Shingrix.
What to tell patients about the side effects of Shingrix:
Most people have a sore arm after they get Shingrix. Many people have redness and swelling on their arm spanning several inches where they got the shot. Many people also feel tired or have muscle pain, a headache, shivering, fever, stomach pain, or nausea.
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How Is Shingles Treated
You can shorten and improve a shingles attack by quick treatment with antiviral drugs. Those include acyclovir, valcyclovir, or famcyclovir.
Pain medicine can relieve some of the pain caused by shingles. Wet compresses, calamine lotion, and oatmeal baths may help relieve some of the itching.
For most healthy people who receive treatment quickly, the pain should subside within three to five weeks and the blisters often leave no scars.
If you think you may have shingles, call your health care provider as soon as possible to discuss treatment options.
How Does The New Vaccine Work
Shingrix contains broken-down parts of the virus which then allow the body to build up immunity to the virus. When the body confronts the actual virus in the future, it mounts a response to keep the infection at bay. The vaccine also contains molecules that make the bodys immune response stronger and last longer.
For these reasons, Shingrix provides better and longer-lasting protection against both shingles and PHN than the older vaccine, Zostavax.
Protection from the older vaccine wore off after approximately eight years, but we believe Shingrix to last much longer.
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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.
*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
Considerations For Patients Who Previously Received Zostavax
Studies have not examined the safety and immunogenicity of Shingrix administered less than 5 years following Zostavax vaccination. However, there are no data or theoretical concerns to indicate that Shingrix would be less safe or less effective when given at an interval shorter than 5 years following Zostavax. Since the risk of herpes zoster increases with age, providers should weigh a patients risk of herpes zoster with the age-specific protection expected from Zostavax to determine when to vaccinate with Shingrix.
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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.
How Do You Get The Vaccine And Should You Get It
Youll have to get a prescription from your physician, pick up the vaccine, then return for the injection.
But should you consider getting it? While thats something youll need to discuss with your doctor, according to Quach, one thing is clear. The older you are, the more benefit youre going to derive from this vaccine.
Debbie Airhart will certainly be looking into the new shot, both for herself, and her parents. I would definitely consider it, she says. I wouldnt wish shingles on anybody.
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Before Taking This Medicine
You should not receive Shingrix if you have ever had a life-threatening allergic reaction to inactivated zoster virus vaccine.
Tell your doctor if:
you have ever had an allergic reaction to any vaccine or
you have fainted after receiving an injection.
Tell your doctor if you are pregnant or breastfeeding.
Shingrix Vaccine Efficacy And Duration Of Protection
Among immunocompetent adults 50 years and older, the efficacy of two doses of Shingrix for the prevention of herpes zoster was high among all age groups. In a clinical trial of more than 30,000 participants, vaccine efficacy was 96.6% in adults aged 50 to 59 years, 97.4% in adults aged 60 to 69 years, and 91.3% in adults aged 70 years and older.
The efficacy of two doses of Shingrix for the prevention of postherpetic neuralgia was high: 91.2% in adults aged 50 years and older, and 88.8% in adults aged 70 years and older.
Vaccine efficacy was estimated among several immunocompromised groups:
- 68.2% among adult autologous hematopoietic cell transplant recipients.
- 87.2% in a post hoc efficacy analysis of adult patients with hematologic malignancies.
- 90.5% in a post hoc efficacy analysis of adult patients with immune-mediated diseases who were not taking immunosuppressive medication.
In immunocompetent adults 70 years and older, vaccine efficacy remained high, at or above 84% in all 7 years after vaccination.
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Shingrix Vs Zostavax: Differences Similarities And Which Is Better For You
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.
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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Persons With Chronic Diseases
Although definitive data are lacking, individuals with autoimmune disease not being treated with immunosuppressive drugs are not considered significantly immunocompromised. Individuals 50 years of age without contraindications should receive RZV.
Im Living With Hiv Is It Safe For Me To Get Shingrix
The Centers for Disease Control and Prevention hasnt made a recommendation about the use of Shingrix in people living with HIV.
However, one study looked at healthy adults ages 18 and older who were living with HIV and had an HIV dosing schedule that was customized to their needs. These people received the Shingrix vaccine, and the study results did not report any safety issues.
If youre living with HIV, talk with your doctor about the risks and benefits of getting Shingrix.
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Whats Different About The New Vaccine
Experts say that based on data from clinical trials, the new shingles shot, Shingrix, differs from Zostavax, an older vaccine thats been in use in Canada for about 10 years, in two main ways. First of all, says Dr. Caroline Quach, medical lead, infection prevention and control at CHU Sainte-Justine in Montreal, it offers greater protection 90 to 95 percent versus 60 to 70 percent. And its nearly as effective when given at age 80 or 90 as at 50.
When you hit 70, the older vaccine tended to be less effective, Quach explains.
The only unknown is how long the protection lasts, she adds, since so far, studies have tracked participants for only four years. In other words, it may turn out a booster shot is needed.
Shingrix can also be given even if youve already had the older vaccine, and some family physicians, like Dr. Karen Cunningham, of London, Ont., anticipate that in such cases, theyll recommend doing exactly that.
The downsides? The newer vaccine needs to be given in two doses, two to six months apart , and is more likely to cause temporary side-effects such as fever and headache or redness and swelling at the injection site .
Shingrix is also more expensive $244 plus any dispensing and vaccination fees, versus $177 for the competitor although some private plans may pick up the tab.