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.
How Cdc Monitors Vaccine Safety
CDC and FDA monitor the safety of vaccines after they are approved or authorized. If a problem is found with a vaccine, CDC and FDA will inform health officials, health care providers, and the public.
CDC uses 3 systems to monitor vaccine safety:
- The Vaccine Adverse Event Reporting System : an early warning system, co-managed by CDC and FDA, to monitor for potential vaccine safety problems. Anyone can report possible vaccine side effects to VAERS.
- The Vaccine Safety Datalink : a collaboration between CDC and 9 health care organizations that conducts vaccine safety monitoring and research.
- The Clinical Immunization Safety Assessment Project: a partnership between CDC and several medical research centers that provides expert consultation and conducts clinical research on vaccine-associated health risks.
What Are The Advantages Of Getting The Shingles Vaccine
The shingles vaccine reduces your risk of getting shingles. Shingles causes a painful rash that usually develops on one side of your body or face. Some people describe the pain as an intense burning or shooting sensation. The rash is often a single strip that wraps around one side of your body or is on one side of your face. It consists of blisters that normally crust over in seven to 10 days. The rash generally clears up within a month.
For some people, the pain from the rash can last for months or even years after the rash goes away. This long-term pain is called postherpetic neuralgia , and it is the most common complication of shingles.
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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.
Itchy Skin Near The Injection Site
Itchy skin, also called pruritus, can potentially occur near the injection site after receiving Shingrix. Itching, swelling, and redness arent usually a huge cause for concern, as they often occur together as a localized reaction.
Applying Benadryl gel or hydrocortisone cream around the injection area can help reduce itchy, swollen, or red skin. If the itching worsens or spreads away from the injection site, get in touch with your doctor.
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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.
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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Who Shouldnt Get The Shingles Vaccine
You shouldnt receive the shingles vaccine if:
- Youve had a previous severe allergic reaction to Shingrix or any of its ingredients.
- Youre pregnant or breastfeeding.
- You have no immunity to chickenpox, which means you should get the chickenpox vaccine instead.
Having a mild illness like a cold isnt a reason to not get your shingles vaccine.
However, if you have a moderate to severe illness or a fever of 101.3 or higher, you should recover before getting your shingles vaccine.
state that the COVID-19 vaccine may be given without regard to the timing of other vaccines.
This means you dont have to wait to receive your COVID-19 and shingles vaccinations.
In fact, you can get your COVID-19 vaccine and shingles vaccine at the same time. If you choose to do this, make sure to receive your injections at two different sites.
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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Risks Of A Vaccine Reaction
- A sore arm with mild or moderate pain is very common after recombinant shingles vaccine. Redness and swelling can also happen at the site of the injection.
- Tiredness, muscle pain, headache, shivering, fever, stomach pain, and nausea are common after recombinant shingles vaccine.
These side effects may temporarily prevent a vaccinated person from doing regular activities. Symptoms usually go away on their own in 2 to 3 days. You should still get the second dose of recombinant shingles vaccine even if you had one of these reactions after the first dose.
Guillain-BarrÃÂ© syndrome , a serious nervous system disorder, has been reported very rarely after recombinant zoster vaccine.
People sometimes faint after medical procedures, including vaccination. Tell your provider if you feel dizzy or have vision changes or ringing in the ears.
As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.
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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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Make A Plan To Get 2 Doses
- You can get Shingrix at your doctors office or pharmacy. Talk to your doctor or pharmacist about getting Shingrix.
- Plan to get your second dose of Shingrix 2 to 6 months after your first dose.
Five years later, I still take prescription medication for pain. My shingles rash quickly developed into open, oozing sores that in only a few days required me to be hospitalized. I could not eat, sleep, or perform even the most minor tasks. It was totally debilitating. The pain still limits my activity levels to this day.
A 63-year-old harpist who was unable to continue playing due to shingles
Spacing Of Multiple Doses Of The Same Antigen
Vaccination providers should adhere to recommended vaccination schedules . Administration at recommended ages and in accordance with recommended intervals between doses of multidose antigens provides optimal protection.
Administration of doses of a multidose vaccine using intervals that are shorter than recommended might be necessary in certain circumstances, such as impending international travel or when a person is behind schedule on vaccinations but needs rapid protection. In these situations, an accelerated schedule can be implemented using intervals between doses that are shorter than intervals recommended for routine vaccination . The accelerated or minimum intervals and ages for scheduling catch-up vaccinations. Vaccine doses should not be administered at intervals less than these minimum intervals or at an age that is younger than the minimum age.*
Certain vaccines produce increased rates of local or systemic reactions in certain recipients when administered more frequently than recommended . Careful record keeping, maintenance of patient histories, use of immunization information systems , and adherence to recommended schedules can decrease the incidence of such reactions without adversely affecting immunity.
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Shingrix Dosage And Schedule
Shingrix should be administered to immunocompetent adults aged 50 years and older and adults aged 19 years who are or will be immunodeficient or immunosuppressed because of disease or therapy as a two-dose series , 2 to 6 months apart . However, for persons who are or will be immunodeficient or immunosuppressed and who would benefit from completing the series in a shorter period, the second dose can be administered 12 months after the first. See more detailed clinical guidance.
If more than 6 months have elapsed since the first dose of Shingrix, you should administer the second dose as soon as possible. However, you do not need to restart the vaccine series.
If the second dose is given less than 4 weeks after the first dose, the second dose should be considered invalid. A valid second dose should be administered 2 months after the invalid dose .
Who Should Get The Shingles Vaccine
The CDC recommends it for healthy adults over the age of 50, but the FDA has approved Shingrix for people 18 and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. This includes those who have already had shingles, which you can have more than once. Vaccination lowers the chances of a second round of the painful rash and of a serious outbreak and complications, Kistler says.
Thatâs why Duncan Isley, who had shingles at 45, recently got vaccinated. The outbreak he had was âfairly mildâ compared with the stories heâs heard from others. But itâs something he doesnât want to repeat.
âI had the classic torso rash and back pain. It was a very painful experience to be sure, and I still have some lingering, minor nerve sensations from time to time,â says Isley, who is now 53 and lives in Durham, NC. âI tell my close friends they should get vaccinated.â
You should also get vaccinated with Shingrix if you got an older shingles vaccine called Zostavax, which was withdrawn from the market in 2020. Zostavaxâs protection wears off with time, says Kathleen Dooling, MD, MPH, a medical officer and shingles disease expert at the CDC.
In the first year after vaccination, Zostavax prevented shingles about 60% of the time. âThat decreases in subsequent years, so that after a number of years itâs not clear that the vaccine is providing any protection,â she says.
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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 .
Side Effects Of Shingrix
Shingrix comes with one drawback, though, according to the Centers for Disease Control and Prevention . Some of thecommon side effects, like arm pain, redness at the injection site, muscle pain and fevers became more common. They can last up to three days and be intense enough to limit your activity during that time.
Injection-site reactions during the clinical trial were common. Heres what patients experienced:
If you have pain or swelling at the injection site, Baker says, You can take Tylenol or ibuprofen. She adds that injection-site reactions like pain, redness and swelling expected and normal.
Systemic effects were also common, with 10% of people reporting that the symptoms were intense enough to limit their activity. Others reported the following:
- 17% gastrointestinal symptoms like nausea or diarrhea
If you are experiencing systemic symptoms after taking the vaccination, Baker says, Its certainly fine to take through the first two to three days when having symptoms. If the symptoms last longer than that, she says its time to call your healthcare provider.
The vaccine also may increase the risk of Guillain-Barre syndrome, a rare complication that can cause temporary paralysis.
As with any vaccine, anaphylactic shock is less likely, but a possible reaction. If you have hives, swelling of the face or throat, difficulty breathing or an elevated heart rate within hours of receiving the vaccine, you should contact your healthcare provider right away.
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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.
Shingrix Approved In The Us For Prevention Of Shingles In Adults Aged 50 And Over
Pooled clinical trial results showed > 90 percent efficacy across all age groups
Issued: London UK
GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Shingrix for the prevention of shingles in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: Shingrix represents a significant scientific advancement in the field of vaccinology. The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects 1 in 3 people in the United States.1 The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity.
Approval of Shingrix is based on a comprehensive Phase III clinical trial program evaluating its efficacy, safety and immunogenicity in more than 38,000 people. In a pooled analysis of these studies, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of 4 years.2,3 By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia , a form of chronic nerve pain and the most common complication associated with shingles.
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Who Should Not Get The Vaccine
It is safe for most people to get two doses of Shingrix. However, you should talk to your healthcare provider before getting the shingles vaccine if:
- You are pregnant
- You have severe allergies to any of the Shingrix ingredients
- You have ever experienced a severe allergic reaction to Shingrix
If you have a mild sickness, such as a cold, its usually safe to get the shingles vaccine. If you are moderately or severely ill, you should wait until you feel better to get your next dose of Shingrix.
You should still get the shingles vaccine if you dont remember having the chickenpox virus in the past and if youve had shingles previously. Shingrix can protect you against developing shingles again in the future.