13. Shingrix (Zoster Vaccine Recombinant, Adjuvanted) was approved in October 2017 for adults 50 and older for the prevention of shingles, a viral infection that causes a painful rash that generally develops on 1 side of the body, usually the face or torso. From FDA website https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM584456.pdf20. US Food and Drug Administration. If you’ve had chickenpox, the virus that causes shingles is already inside your body and can reactivate. http://www.cdc.gov/vaccines/pubs/pinkbook/index.html200. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial. Application number 125614: Summary Basis for Regulatory Action. Note: This document contains side effect information about zoster vaccine, inactivated. Signs And Symptoms At Injection Site "Product Information. 5. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). Recommended immunization schedule for adults 19 years or older, United States, 2018. You and patients should make every effort to ensure that two doses are administered within the recommended 2-6 month interval. Low Energy 7. Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine - United States, 2017-2018. Centers for Disease Control and Prevention. http://www.aidsinfo.nih.gov166.
Chills 2.
Hales CM, Harpaz R, Ortega-Sanchez I et al. Prevention of herpes zoster (zoster, shingles) in adults ≥50 years of age.Zoster is caused by reactivation of latent VZV infection in individuals who previously had varicella (chickenpox) infection.Zoster vaccine recombinant is used to boost active immunity to VZV, thereby reducing risk of VZV reactivation.There are 2 different types of zoster vaccine commercially available in the US for immunization against zoster in adults ≥50 years of age: zoster vaccine recombinant (RZV; ShingrixFor prevention of zoster in immunocompetent adults ≥50 years of age, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that zoster vaccine recombinant (not zoster vaccine live) is preferred and can be used in such individuals regardless of history of zoster or prior vaccination with varicella virus vaccine live or zoster vaccine live.For prevention of zoster in immunocompetent adults ≥60 years of age, ACIP states that either zoster vaccine recombinant or zoster vaccine live can be used.May be given concurrently with other age-appropriate vaccines.Be aware that 2 different types of zoster vaccine are commercially available in the US (zoster vaccine recombinant [RZV; ShingrixFDA alerted healthcare professionals about multiple reports of medication errors related to confusion about the 2 different zoster vaccines (e.g., incorrect reconstitution, incorrect route of administration, incorrect interval or number of vaccine doses, inappropriate age of vaccinee, administration after incorrect storage).Administer reconstituted zoster vaccine recombinant by IM injection, preferably into deltoid region of upper arm.To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique.Commercially available as a kit containing single-dose vials of lyophilized VZV gE antigen and single-dose vials of AS01Prior to administration, reconstitute a single-dose vial of lyophilized VZV gE antigen from the kit by adding entire contents of a single-dose vial of adjuvant suspension from the kit according to the manufacturer's directions.Administer immediately after reconstitution or store at 2–8° for up to 6 hours.Give zoster vaccine recombinant in a series of 2 doses.If interruptions or delays result in an interval >6 months between the 2 doses, ACIP states vaccine series does not need to be restarted; however, efficacy of dosing interval >6 months not evaluated to date.A 2-dose regimen recommended regardless of history of zoster or prior vaccination with varicella virus vaccine live or zoster vaccine live.If used in those who previously received zoster vaccine live, give zoster vaccine recombinant ≥2 months after zoster vaccine live.History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of the vaccine.Take all known precautions to prevent adverse reactions, including a review of the patient’s history with respect to possible hypersensitivity to the vaccine or previous vaccine-associated adverse reactions.Have appropriate medical treatment readily available in case an anaphylactic reaction occurs.Individuals with altered immunocompetence were excluded from initial clinical trials evaluating safety and efficacy of zoster vaccine recombinant.ACIP states that recombinant vaccines generally can be administered safely to individuals with altered immunocompetence.Recommendations for use of recombinant vaccines in HIV-infected individuals usually are the same as those for individuals without HIV infection.Immune response and efficacy may be reduced in individuals receiving immunosuppressive therapy.Base decision to administer or delay vaccination in an individual with a current or recent acute illness on severity of symptoms and etiology of the illness.May be administered to age-appropriate adults with certain chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease).ACIP states mild acute illness generally does not preclude vaccination.ACIP states moderate or severe acute illness (with or without fever) is a precaution for vaccination;Duration of protection against zoster following a 2-dose series of zoster vaccine recombinant not fully determined.Data to date indicate duration of protection following a 2-dose series is at least 4 years;Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.Data not available regarding use of zoster vaccine recombinant in pregnant women.ACIP states consider deferring administration of zoster vaccine recombinant in pregnant women.Not known whether zoster vaccine recombinant vaccine is distributed into milk, affects milk production, or affects the breast-fed infant.Consider benefits of breast-feeding and clinical importance of the vaccine to the woman along with potential adverse effects on the breast-fed child from the vaccine or the underlying maternal condition (i.e., susceptibility to reactivation of VZV infection).ACIP states that recombinant vaccines generally do not pose any unusual risks for women who are breast-feeding or their breast-fed infants.Safety and efficacy not established in pediatric patients.No clinically meaningful differences in efficacy among various age groups of adults ≥60 years of age or between those ≥60 years of age and those 50–59 years of age;Concurrent administration with other age-appropriate vaccines or toxoids during the same health-care visit (using separate syringes and different injection sites) not expected to affect immunologic responses or adverse reactions to any of the vaccines.Potential for decreased immune responses to zoster vaccine recombinantCorticosteroids: Zoster vaccine recombinant may be used in those receiving low-dose systemic corticosteroid therapy (prednisone or equivalent in a dosage <20 mg daily) or inhaled or topical corticosteroid therapy;Parenteral non-adjuvant-containing influenza virus vaccine inactivated: Concurrent administration of inactivated influenza vaccine (FluarixAdjuvant-containing influenza virus vaccine inactivated (FluadParenteral non-adjuvant-containing influenza virus vaccine inactivated: May be given concurrently with zoster vaccine recombinant (using separate syringes and different injection sites)Zoster vaccine recombinant has been administered to adults who received zoster vaccine live ≥5 years earlier;If used in adults who previously received zoster vaccine live, ACIP recommends that zoster vaccine recombinant be given ≥2 months after zoster vaccine liveVials containing lyophilized gE antigen: 2–8°; protect from light.Zoster vaccine recombinant is an inactivated (recombinant) vaccine used to boost immunity to VZV, thereby reducing the risk of reactivation of VZV and development of zoster and complications of the disease.Commercially available as a kit containing single-dose vials of lyophilized VZV gE antigen and single-dose vials of AS01The recombinant VZV gE antigen component is prepared using recombinant DNA technology and Chinese hamster ovary (CHO) cells.Administration of a 2-dose vaccination series of zoster vaccine recombinant in adults ≥50 years of age boosts VZV-specific cell-mediated immune responses and VZV-specific humoral immunity resulting in a reduced risk of zoster and PHN in vaccinees.Herpes zoster (zoster, shingles) and varicella (chickenpox) are distinct clinical entities caused by the same virus, VZV.Zoster is characterized by unilateral, painful, vesicular cutaneous eruption with a dermatomal distribution.Minimum immune response that correlates with protection against zoster not established.Prior to administration, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at Advise patient of the risks and benefits of vaccination with zoster vaccine recombinant.Advise patient of the importance of receiving 2 doses of zoster vaccine recombinant given 2–6 months apart.Advise patient that zoster vaccine recombinant may not provide protection in all vaccinees.Inform patients about the potential for adverse reactions temporally associated with the vaccine.Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.Importance of informing patients of other important precautionary information.For injectable suspension, for IM use, 50 mcg of recombinant varicella zoster virus glycoprotein E antigen per 0.5 mL2. 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