Wednesday, September 27, 2023

Is Shingrix A Recombinant Vaccine

Contraindications And Precautions For Herpes Zoster Vaccination

Shingles Vaccine Meets Unprecedented Demand

Shingrix should not be administered to:

  • A person with a history of severe allergic reaction, such as anaphylaxis, to any component of a vaccine or after a previous dose of Shingrix
  • A person who is known to be seronegative for varicella
  • It is not necessary to screen for a history of varicella. However, if a person is known to be varicella-negative via serologic testing, providers should follow ACIP guidelines for varicella vaccination.
  • A person experiencing an acute episode of herpes zoster. Shingrix is not a treatment for herpes zoster or postherpetic neuralgia . The general guidance for any vaccine is to wait until the acute stage of the illness is over and symptoms abate.
  • Shingrix has not been studied in pregnant women or women who are breastfeeding. Providers should consider delaying Shingrix vaccination for these women.Adults with a minor acute illness, such as a cold, can receive Shingrix. Adults with a moderate or severe acute illness should usually wait until they recover before getting the vaccine. This includes anyone with a temperature of 101.3°F or higher.To learn more, see Contraindications and Precautions, General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices .

    Are Dna Vaccines Safe

    Written by Deep Shukla on September 28, 2021 Fact checked by Anna Guildford, Ph. D. DNA and RNA vaccines use genetic material to deliver information to human cells and elicit an immune response. DNA vaccines are safe, easy, affordable to produce, and, unlike RNA vaccines, are stable at room temperature.

    How Can I Learn More

    • Ask your healthcare provider.
    • Contact the Centers for Disease Control and Prevention :
    • Call 1-800-232-4636 or visit the CDC’s website at

    Recombinant Zoster Vaccine Information Statement. U.S. Department of Health and Human Services/Centers for Disease Control and Prevention. 10/30/2019.

    Don’t Miss: Cvs Dtap Vaccine

    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.

    Dose Route Of Administration And Schedule

    New Shingles vaccine available to anyone over 50

    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 .

    Recommended Reading: Can I Get Tdap At Cvs

    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.

    Drug Interactions Of Shingrix Vs Zostavax

    Immunosuppressive drugs such as cyclosporine and tacrolimus can decrease the effectiveness of vaccines. Steroids, like prednisone, and chemotherapy can also have immunosuppressive effects that can alter how vaccines work.

    Those who are on immunosuppressive therapy should avoid Zostavax altogether Zostavax contains the live virus, which could result in an infection.

    Antiviral drugs such as acyclovir and famciclovir can interfere with the effects of the Zostavax vaccine. The Advisory Committee on Immunization Practices recommends that people who are on antiviral drugs stop taking antiviral medications 24 hours before getting a Zostavax vaccine. Treatment with antiviral drugs should not be resumed for at least 14 days after vaccination with Zostavax.


    Consult a healthcare professional for other possible drug interactions

    Don’t Miss: How Much Does A Tdap Shot Cost At Cvs

    Shingrix And Other Medications

    Below are medications that can interact with Shingrix. These are not all the drugs that may interact with Shingrix.

    Before taking Shingrix, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

    If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

    Immunosuppressive drugs such as prednisone

    Taking Shingrix with drugs that suppress your immune system can cause problems with the way your body responds to Shingrix. Examples of immunosuppressive medications include:

    • corticosteroids, such as:

    Here are answers to some frequently asked questions about Shingrix.

    Exposure And Index Date Definition

    Shingrix® Update for Pharmacists

    We identified RZV and ZVL vaccinations using national drug codes in Medicare Part D claims . All beneficiaries started as unvaccinated on the index date of 1 November 2017 and switched to the subsequent vaccinated cohorts 30 days after the corresponding vaccination date to account for the time for a biological immune response. Additional beneficiaries cannot enter the study after the index date. Beneficiaries contributed survival time according to their status. For example, individuals who experienced an outcome prior to their first dose were censored on the outcome date and thus did not contribute any time to the first-dose population. We defined influenza vaccinees using Current Procedural Terminology/Healthcare Common Procedure Coding System codes Supplementary Table 3) .

    Don’t Miss: Can I Get A Tdap Shot At Cvs

    Medicare Coverage For Shingles Vaccine

    Shingrix is not the first shingles vaccine, but it is the only one currently on the market in the United States.Instead of using a live virus,the vaccine uses a protein from the virus to trigger an immune response. It is administered in two doses two to six months apart.

    This shingles vaccine has been shown to decrease the risk for shingles by 97% for people between 50 and 69 years old and by 91% for people 70 and older. It reduces complications as well. The risk for post-herpetic neuralgia goes down by 91% and 89%, respectively, in those age groups.

    Because the vaccine works well, it is important to know if and when Medicare covers it.

    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.

    Recommended Reading: Does Cvs Give Tetanus Shots

    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 Adverse events following immunization in Part 2 and the product monograph in Health Canada’s Drug Product Database.

    Shingrix For Prevention Of Shingles

    Shingles (Herpes Zoster)

    Shingrix is a vaccine thats used to prevent shingles . Its approved for use in people:

    • ages 50 years and older
    • ages 18 years and older who have an increased risk of shingles

    People with an increased risk of shingles include those with a weakened immune system, such as people with HIV.

    Shingrix is 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

    state that Shingrix is the preferred vaccine for shingles. They recommend it for:

    • all adults ages 50 years and older
    • adults ages 18 to 50 years with a weakened immune system

    Read Also: How Much Is The Tdap Vaccine At Cvs

    Shingrix A New Vaccine Approved For Herpes Zoster Prevention In Older Adults

    Herpes zoster, also known as shingles, is characterized by a painful itchy rash on one side of the face or body that lasts for 2 to 4 weeks. It is caused by the varicella zoster virus, the same virus that causes chickenpox. An estimated 1 million people have herpes zoster infection annually in the United States, and 1 of 3 Americans will have the infection in their lifetime.1 People with weakened immune systems, including those with leukemia, lymphoma, or HIV, have an increased risk for shingles.1

    The most common complication associated with herpes zoster infection is postherpetic neuralgia, which is associated with severe pain in the areas affected by the shingles rash.1 For most patients, postherpetic neuralgia pain resolves within weeks to months however, a minority of patients can have symptoms for years.1 Postherpetic neuralgia is observed in approximately 20% of patients with shingles and in up to 50% of patients aged 60 years.1,2

    The first vaccine approved by the US Food and Drug Administration for the prevention of herpes zoster is Zostavax , a live-attenuated zoster vaccine. It was approved in 2006 for people aged 60 years in 2011, the age was reduced to 50 years.3

    Shingrix a New Vaccine Approved for Herpes Zoster Prevention

    Mechanism of Action

    The risk for herpes zoster infection is related to a decline in varicella zoster virusspecific immunity. Shingrix boosts the immune response to the varicella zoster virus.8

    Dosing and Administration

    The ZOE-50 Study

    Live Shingles Vaccine Vs Non

    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 .

    Zostavax was a shingles vaccine that was live.

    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.

    You May Like: Where To Get Tdap Vaccine Cvs

    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.

    For Media And Investors Only

    June 25, 2021 ACIP Meeting – Welcome & Zoster Vaccines

    Issued: Philadelphia, London

    GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Shingrix for the prevention of shingles in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.

    Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix is not indicated for prevention of primary varicella infection . The approval for this new population expands the number of people who can be protected against shingles by Shingrix.

    Were proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease, said Thomas Breuer, Chief Medical Officer, GSK Vaccines. Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition.

    Also Check: Does Cvs Give Tdap Shots

    Data Sources And Study Design

    The primary data sources were Medicare claims and enrollment databases. We derived demographic and death information from the enrollment databases and information on vaccinations, health covariates, preventive services, and outcomes from Medicare Part A , Part B , and Part D claims. Supplemental data on health-seeking attitudes and frailty conditions were captured from the Medicare Current Beneficiary Survey . We used a prospective cohort design with a study period from 1 November 2017 to 20 October 2019 .

    Side Effects Of The Shingles Vaccine: Is It Safe

    Shingles is a painful rash caused by varicella zoster, the same virus responsible for chickenpox.

    If you had chickenpox as a child, the virus hasnt completely gone away. It hides dormant in your body and can reemerge many years later as shingles.

    About 1 in 3 people in the United States will develop shingles in their lifetime. This is why vaccination is important. But you should also be prepared for possible side effects. In this article, well discuss the side effects, and talk about who should get the vaccine.

    Older adults are most likely to develop shingles. This is why the shingles vaccine is recommended for people ages 50 and older.

    Shingrix is the only shingles vaccine approved by the U.S. Food and Drug Administration .

    The Shingrix vaccine is a recombinant vaccine. This means vaccine manufacturers created it by altering and purifying DNA that creates an immune response to fight the virus.

    The CDC recommends Shingrix for the prevention of shingles and related complications. The Shingrix vaccine is also recommended for anyone who has already gotten another type of shingles vaccine.

    Currently, the CDC recommends healthy people ages 50 and older get the Shingrix vaccine. Doctors administer the vaccine in two doses, which are given 2 to 6 months apart.

    The Shingrix vaccine has high success rates in protecting people against shingles.

    The Shingrix vaccine is as much as effective in preventing shingles. The same is true for Shingrix and postherpetic neuralgia.

    Also Check: How Much Does The Shingles Vaccine Cost At Cvs

    Herpes Zoster Vaccine: Canadian Immunization Guide

    For health professionals

    Last complete revision:

    July 2018 This chapter was revised to reflect NACI’s Updated Recommendations on the Use of Herpes Zoster Vaccines. Most sections were revised to include information and practice recommendations for the new recombinant zoster vaccine which is now available in Canada. Changes include:

    • Recommendations for use in different populations.
    • Contraindications and precautions.
    • Administration of the HZ vaccines: Table 1 was added to summarize key information.
    • Considerations on the efficacy, effectiveness and immunogenicity of HZ vaccines: Table 2 was added to summarize key information.
    • Vaccine safety and adverse events.

    How Safe Is Shingrix

    CDC Suggests People 50 and Older Receive New Shingles Vaccine

    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.

    Don’t Miss: How Much Does Shingles Vaccine Cost At Cvs

    Popular Articles
    Related news